November 2019 - n°60

EUROPE & For effective policies in Europe PROTECTING HEALTH, SAVING LIVES EU cooperation against -preventable diseases

2.7 million Worldwide MEASLES vaccines million 2 NEONATAL prevent TETANUS every year 1 million PERTUSSIS

VACCINATION IN THE EU INFECTIOUS DISEASES ON THE RISE Influenza vaccination coverage rates V More than 14 000 measles & among people aged 65+ 696 rubella cases in 2017 UK 71% RO - 5 608 measles NL 67% IT - 5 098 measles EU 34% DE - 929 measles BG 2% GR - 967 measles EE 2% EU ACTION DISTRUST IN VACCINES Ensure ACCESS to vaccines for all

0% Control all vaccines to ensure HIGHEST SAFETY STANDARDS

Share CLEAR, INDEPENDENT 45.5% and TRANSPARENT information “ I think vaccines More RESEARCH to develop new vaccines

are not safe” Confidence Project Sources: ECDC; Eurostat; WHO; The Vaccine

European Commission: ec.europa.eu/health/vaccination/overview_en European Centre for Disease Prevention and Control: ecdc.europa.eu @EU_Health #EUvaccines

Health and Food Safety E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 3

EDITORIAL EUROPE & VACCINES

accination is the primary instrument interest of vaccination should be more clearly vaccination programmes. The Commission is for prevention in public health. Thanks highlighted. Providing reliable information considering the creation of a European virtual V to vaccination programmes, life to the general public and dispelling myths data warehouse on vaccine needs, which expectancy in the world is one of humanity’s about vaccines and vaccination through the could facilitate the voluntary exchange of greatest achievements. According to the exchange of good practices is key to ensure information on available supplies. This would WHO, vaccination can prevent between 2 and effective public health. ensure that the necessary measures are in 3 million deaths per year worldwide. place in the event of a pandemic. For several years now, the sub-optimal Nowadays, several European and neigh- vaccination coverage observed in Europe Vaccination policies fall within the purview bouring countries are facing the return of has led the European Commission to step of national authorities. However, the EU some epidemics thought to be long forgotten, up its vaccination efforts by working closely must ensure fair access to vaccines for all EU the resurgence of which is mainly due to a lack with Member States. In December 2018, citizens through free distribution in order to of vaccination coverage. the Council adopted a recommendation to remove major financial barriers, combat dis- strengthen EU cooperation against vaccine- information and build confidence in vaccines, In an increasingly digitalized and intro- preventable diseases. Subsequently, it estab- facilitating a vaccination pathway from an Vverted society, misinformation is on the rise, lished a roadmap to ensure better cooperation early age. social media pose a new challenge when it between Member States. A feasibility study on comes to maintaining confidence in immu- the development of a common EU vaccination Vaccination is first and foremost about nization. However, the use of digital tools map was launched this year. A draft common education for all of us. In this issue of The would facilitate and improve vaccination vaccination document, which could help EU European Files, we capture the responses of programmes throughout Europe, using citizens to continue their vaccination in the our institutions and hope to encourage a interoperability of systems, monitoring data, Member States, is expected to be completed public discussion faithful to the greater good. procurement and a real-time supply status, in 2022. preventing waste, all as a way of fighting fire Editor-in-Chief with fire. Europe plays an important role in the pro- LAURENT ULMANN duction of these vaccines. Several European Our policies and scientists must have a clear countries have experienced a shortage of and unambiguous narrative about the need vaccine production and supply which has for vaccination and its coverage. The collective hampered the implementation of their

Management: The European Files / Les Dossiers Européens - 19 rue Lincoln, 1180 Brussels www.europeanfiles.eu - ISSN 1636-6085 - email: [email protected] Publication Director and Editor-in-Chief: Laurent ULMANN Layout & printing: VAN RUYS PRINTING Copyright: Shutterstock, European Commission 4 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Europe & Vaccines TABLE OF CONTENTS For effective vaccination policies in Europe

The benefits of digital tools for improving Sustain vaccination programmes through a healthier immunisation programmes 6 vaccine ecosystem in an interconnected Europe 16 Krista Kiuru, Finnish Minister for Family Affairs and Social Corinne Bardone, Pharm D, Head of Global Vaccines Public Services Affairs, for Polio, Pertussis and Hib containing Vaccines, Sanofi Pasteur To eliminate measles in Germany: The Measles Protection Christina Klein, Manager, Global Vaccine Public Affairs, Act. Requirement for all children entering school or Sanofi Pasteur kindergarten to have both measles 7 Jens Spahn, Germany’s Federal Health Minister Florence Baron-Papillon, Pharm D, Head of Public Affairs Europe for Vaccines, Sanofi Pasteur Place vaccination at the forefront of the public space 8 Agnès Buzyn, French Minister for Solidarity and Health, Looking ahead to the next decade for Extract from the article in European immunisation week in Europe 19 Dr. Siddhartha Datta, Programme Manager, Vaccine- Dedicated supra-structural vaccination organizations: preventable Diseases and Immunization programme, WHO the driver of a successful vaccination schemes 10 Regional Office for Europe Maggie De Block, Belgian Minister of Social Affairs and Public Ms. Catharina de Kat, Communications, Web and Health and Asylum Policy and Migration Information Officer, Vaccine-preventable Diseases and Immunization programme, WHO Regional Office for Europe Promote vaccination, particularly the childhood immunisation programme and the HPV vaccine Securing a robust vaccine sector in Europe 20 for both girls and boys 11 Magdalena Rodriguez de Azero, Executive Director, Simon Harris, Irish Minister for Health Vaccines Europe

European Commission roadmap on vaccination 12 Harnessing the power of partnerships to Anne Bucher, Director-General DG SANTE, European develop life-saving vaccines 22 Commission Dr. Pierre Meulien, Executive Director, Innovative Medicines Initiative (IMI) A : how to eradicate -related cancers in Europe? 13 Vaccination, Population Health, and Véronique Trillet-Lenoir, Oncologist and MEP, Renew European Leadership 24 Europe, France, Member of the ENVI Committee David E. Bloom, Harvard T.H. Chan School of Public Health Boston, Massachusetts USA Clinical Evaluation of vaccines 14 Daniel Cadarette, Harvard T.H. Chan School of Public Health Director Executif of EMA Prof. Guido Rasi, Boston, Massachusetts USA

Improving pan-european collaboration in tackling Raising awareness about the importance of vaccine-preventable diseases 15 vaccination in Europe for public health 25 ECDC Director Andrea Ammon, Monika Beňová, MEP (S&D Group), Member of the ENVI Committee E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 5 Europe & Vaccines For effective vaccination policies in Europe

Is Europe Prepared for the Future of Vaccines - The educational and preventive role 37 Vaccines Innovation? 26 Sara Cerdas, MEP (S&D Group), Member of the ENVI Dr. Emmanuel Hanon, Senior Vice President, Head of R&D, Committee GSK Vaccines Dr. Rino Rappuoli, Chief Scientist, GSK Vaccines The EU research programmes in support to vaccine Research & Innovation 38 Dr. Philippe Denoel, Head of External R&D, GSK Vaccines Irene Norstedt, Acting Director, People Directorate, Directorate-General for Research and Innovation, European Vaccination for patients with chronic conditions 28 Commission Marco Greco, President of European Patients’ Forum (EPF) Alessandra Martini, Policy officer, Directorate-General for Research and Innovation, European Commission : public health emergency 29 Rory Palmer, MEP (S&D Group), Member of the ENVI Julia Molto Lopez, Programme assistant EU policies, Committee Directorate-General for Research and Innovation, European Commission Resilient immunisation systems: looking Barbara Kerstiëns, Head of Unit Combatting diseases, beyond high vaccination rates 30 Directorate-General for Research and Innovation, European Sibilia Quilici, Public Policy Director, MSD Commission

Raising awareness about the key role of health Vaccination in Europe – the crucial role of professionals - The role of physicians in vaccination 32 the health care provider 40 Prof. Dr Frank Ulrich Montgomery, President of the Pierre Van Damme, MD, PhD, vice-dean faculty of Medicine Standing Committee of European Doctors (CPME) and Health Sciences, director Centre for the Evaluation of Vaccination, University of Antwerp, Belgium. Vaccination in Pharmacies 33 Michał Byliniak, President of PGEU (The Pharmaceutical Maternal vaccination: A new and highly Group of the European Union) effective policy to improve European pertussis immunisation programmes 42 Independent control contributes to Benoit Soubeyrand Md, Blossom Vaccinology, Lyon, France ensuring vaccine quality 34 Susanne Keitel, Director of the EDQM, Council of Europe

Healthcare distribution: facilitating optimal access and uptake of vaccines in Europe 35 Monika Derecque-Pois, Director General of GIRP

AIM calls for European Action with regard to Vaccination Hesitancy 36 Christian Zahn, President of AIM (International Association of Mutual Benefit Societies) Johdanto

Suomen EU-puheenjohtajakauden järjestelyt nojaavat toimivuuteen ja johdonmukaiseen kestävyyteen. Yhteyshenkilö puheenjohtajakauden ilmettä Tavoitteena on, että vuoden 2019 EU-puheenjohtajuus jättää mahdollisimman pienen ekologisen koskevissa asioissa:

jalanjäljen ja kiinnittää samalla huomion kestäviin ratkaisuihin ja kiertotalouteen. Nina Loisalo visuaalinen suunnittelija Valtioneuvoston kanslia Kestävyysajattelua edustaa myös puheenjohtajakauden visuaalinen ilme, joka on luotu kierrättämällä ja EU-puheenjohtajuussihteeristö uudistamalla vanhaa. Päärooleissa ovat edellisen puheenjohtajakauden ilmeestä jalostettu tunnuskuvio p. 0295 160 295 [email protected] ja uusi EU2019.FI-logo. Niiden käytön periaatteet yhdessä väri- ja typografiamääritysten, digitaalisten sovellusten sekä kuvallisten suuntaviivojen kanssa tarjoavat työkalut monikäyttöisen ja erottuvan visuaalisen ilmeen rakentamiseen.

6 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e A B C D E F

Presidency The benefits of digital of the Council

Valokuvien Logo s.4 Värit s.10 tools for improving luonne s.13 s.5 Logo ja tarkenne Typografia s.11 Kuvakkeet ja Logon erottuminen s.6 Tunnuskuvio s.7 grafiikkas.12 Kuvion rajaaminen s.8 G Elävä tunnuskuvio s.9 immunisation programmes Elementit toisen osapuolen ilmeessä s.14 Comprehensive immunisation information tools could correct the trend by Originaalihakemisto information systems are essential using differentSuunnittelu: context-based deSignal / Timo Kuoppala strategies to s.17 Electronic vaccination registries or immu- counter the spread of misinformation and nisation information systems (IIS) can show create partnerships with civil society and other up-to-date vaccination coverage across all relevant stakeholders. age groups and sub-populations, as well as in Modern website algorithms seek to different geographic or healthcare-providing determine which information a user would areas. Full interoperability of different elec- like to see, based on their previous internet tronic systems and registries is essential. For activity. This might be harmful to both indi- example, the IIS data can be analysed together viduals and society if it leads to increasing with the disease-surveillance data to monitor hesitancy and mistrust concerning vaccines the real-time impact of vaccines, both in or information provided by health authorities. terms of effectiveness and safety. The IIS data On the other hand, sophisticated search algo- Krista KIURU combined with vaccine procurement data rithms could also play an important role in can show the supply situation in real time addressing vaccine hesitancy. Health systems Finnish Minister for Family Affairs and reduce . The IIS can also could be developed to individually tailor and Social Services provide new opportunities to inform those at messages most likely to resonate with citizens. risk that they should be vaccinated. This can The real-time analysis of internet and social- be achieved through automated reminders via media discussions and networks could also be email, SMS alerts and dedicated health apps. utilised in vaccine confidence monitoring and When integrated with electronic healthcare to identify possible safety concerns. records, the reminders can also target healthcare professionals, so that every time a Sustainable EU-level collabo- patient visits any healthcare facility, the visit ration to improve vaccination can be utilised as an opportunity to administer programmes mmunisation programmes are one of the vaccine doses missed during previous visits. Immunisation programmes are the respon- most cost-effective public health inter- All individuals should have easy access to sibility of the Member States. However, it is I ventions, saving millions of lives every year. the data on vaccines they have received. The clear that we should also enhance EU-level In addition to protecting individuals, vaccines IIS can generate individual electronic vacci- collaboration. Pursuant to Article 168 of the can also protect the whole population against nation cards that can be accessed online — Treaty on the Functioning of the European epidemics as well as significantly reduce while respecting data protection and privacy Union (TFEU), a high level of human health healthcare and societal costs. A unique benefit requirements, naturally. protection is to be ensured in the definition of high vaccination coverage is herd Some EU countries already have an opera- and implementation of all Union policies and – population-level protection for individuals tional IIS. However, more effort is still needed activities. Union action, which complements who cannot be vaccinated because they both at EU and Member State level to develop national policies, is to be directed towards are too young or have pre-existing medical operational guidelines and remove infra- improving public health, preventing physical conditions. structural, legal and standardisation barriers and mental illness and disease, and obviating While many new effective and safe vaccines in order to facilitate interoperability and elec- sources of danger to physical and mental have been introduced in national immuni- tronic immunisation-data-sharing. The feasi- health. The EU Joint Action on Vaccines and sation programmes in recent years, vaccines bility of developing a common EU vaccination other initiatives provide important platforms are still underused and vaccine hesitancy card should also be explored as a matter of for the creation of EU-level added value is posing a threat to the high vaccination priority. for immunisation programmes. In addition coverage needed to stop the spread of com- to initiatives and networks, we should also municable diseases in communities and Internet and social media as tools strengthen the role of the European Centre for internationally. to improve vaccination coverage Disease Prevention and Control (ECDC) as an Council Recommendation (2018/C 466/01) Never before has the creation, distribution, EU agency responsible for providing scientific on strengthened cooperation against vaccine- use and, unfortunately, manipulation of infor- advice and support to Member States on the preventable diseases is a comprehensive and mation been this easy. Ideally, the internet development and adaption of new tools to ambitious commitment from the Member should provide fast and easy access to reliable improve vaccination programmes. States and the Commission to jointly ensure information on vaccination to the public. that European citizens have the full benefit However, the experience so far has been that of existing and new vaccines. The recommen- misinformation from anti-vaccine groups may dation highlights eHealth and digital inno- spread even faster than science-based infor- vations as important new tools for improving mation provided by healthcare professionals immunisation programmes. and public-health authorities. New digital E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 7

To eliminate measles in Germany: The Measles Protection Act. Requirement for all children entering school or kindergarten to have both measles vaccinations

in these settings will also have to be vaccinated With all of that, the second shot is easily for- against this dangerous infectious disease. The gotten. We can therefore assume that our new same applies to staff working in healthcare regulation will provide a welcome reminder in facilities. Exempted from mandatory vac- these cases. And I trust that it will result in more cinations are persons for whom the vaccine children getting both measles vaccinations. would not be safe on medical grounds and The case might be different for people who persons born before 1970. In the absence of this are against mandatory immunisation for other proof, the child can be barred from attending reasons. In such cases, reference is often made school or day care. Parents of school children to the question of proportionality and the will face a fine. After all, it is the same as in road right to “free choice regarding vaccination”. traffic: if you put others at risk and get caught, My counterargument is that any person who you have to pay a fine. sits in a paediatrician’s waiting room with their Between August 2018 and late July 2019, baby, who is still too young to be vaccinated, Jens SPAHN more than 13,000 measles cases were reported must be able to rely on the older children in across Europe. In Germany, as many as 485 the waiting room not having measles. That too Germany’s Federal Health Minister cases were registered by early September of is a precondition of freedom – and it applies this year. In 2018, a total of 544 cases were particularly to those entrusted to our care who reported nationally for the entire year. Measles are children. And even more so to children commonly involve complications and lead to who cannot be vaccinated for medical reasons. secondary conditions. One in 1,000 children Naturally, it also becomes the State’s business if who contract measles will develop a brain unvaccinated children attend day care facilities easles are among the most con- inflammation known as measles encephalitis. and schools. This is especially the case if, as in tagious infectious diseases and – Children under five, and adults over 20 years Germany, school attendance is mandatory. M contrary to the widespread narrative of age, are at an increased risk of experiencing Being unvaccinated not only poses a con- – they are not a ‘harmless children’s disease’! serious complications. This clearly debunks siderable threat to the physical well-being In fact, globally, measles cases even doubled in the argument put forward by many vaccine of the affected person themselves but also 2018. In Germany, a large number of children, deniers that measles usually takes a mild course constitutes a risk to other persons who, for young people and adults are still not vaccinated therefore rendering vaccination unnecessary. example, because of their age or specific health against measles. This means that they can shed However, according to current evaluations limitations cannot be vaccinated. That is why and spread the pathogen, causing repeated done by the Berlin-based Robert Koch Institute mandatory vaccination must begin as early outbreaks. We cannot let this go unchallenged. (RKI), despite all of the campaigns to educate as possible and must begin in those places The best protection against measles is vac- the population, the measles vaccination gaps where people come into daily contact with one cination. Vaccines afford immunity for life. in Germany are still too large. While it is true another. Therefore, I most strongly believe that not that 97.1 per cent of all children starting school Vaccination is one of humanity’s greatest only do people who fail to have themselves have had their first shot, there are large regional achievements. We have almost eradicated or their children vaccinated put their own life differences in the numbers of those getting infectious diseases that in earlier generations and health at risk, but, as we live in an open the second, decisive shot. This means that, at took the life of many millions of people. I society, they do the same to others. My goal Federal level, we still fall short of the target therefore have the utmost confidence that is to protect all children in Germany, if at all immunisation coverage of 95 per cent. Only through this piece of legislation vaccination will possible, from measles – at day care this coverage rate can afford what is known as become the norm and vaccination myths will facilities, at their day care mother’s home and ‘’. be exposed. Mandatory vaccination for children at school. This is why we seek to make measles According to new data from the RKI, a good should also cause parents to reflect and to ask vaccination mandatory in all of these settings. 93 per cent of children who started primary themselves: why am I not vaccinated? In short, We want to do this by introducing the “Measles school in 2017 have had two measles shots. mandatory vaccination is health education! Protection Act”. With the approval of the Here, it must be said that not all of the parents In a free country, I must be able to bank on German Bundestag, it will become effective in who failed to get the second shot for their child the fact that the person sitting opposite me spring of next year. on schedule are out and out ‘vaccine deniers’. does not pose a danger to me. That too is a pre- What specific regulations do we have in This can be seen from the fact that the children condition of freedom. We have an obligation mind? Going forward, all children entering already had their first shot. Apparently, there to protect our children, so that they do not school or kindergarten will need to provide are those parents who just lose sight of the become infected and infect others. If parents evidence of the two measles shots recom- second shot and its importance for long-term do not do it, then the State must take action! mended by the German Standing Committee immunity. It may be that the family is growing No child in Germany should ever again become on Vaccinations (STIKO). This proof will also or that the demands of work, the children infected with measles or die as a consequence have to be furnished if the child is being looked starting school and going about their hobbies of this disease. after by a day care mother. Persons who work sometimes make it hard to organise daily life. 8 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Place vaccination at the forefront of the public space

Extending the immunisation obligations to Actions to inform and promote vaccination infants or simplifying the vaccination process have been stepped up. for seasonal influenza vaccination are all measures that redefine and revitalise the vac- With the launch of the vaccination info cination policy in France. service website for the general public and access of this vaccination info service website The European Immunisation Week was first to professionals; launched back in 2005 at the behest of the World Health Organisation. Also with, – and this is the key –, the com- mitment of all professionals. I should like Many events, coordinated by Regional to thank in particular the associations of Health Agencies, such as the “vaccination info health-care professionals that support the villages”, take place in the regions during that government . Their signing Agnès BUZYN Week every year. the charter last fall reflects their commitment French Minister for Solidarity and Health, to promoting the vaccination of these Extract from the article in European These actions bring together a wide panel professionals. immunisation week of field operators: health and education pro- fessionals, the civil society, health insurance We are right to wager on a proactive policy: funds, supplementary mutual insurances, our actions are starting to bear fruit. scientific societies and professional asso- ciations, whom I sincerely thank for their work As I had announced and as prescribed by s you know, vaccination is a topic dear throughout the year towards improving the law, I will present a review of the reform of the to me. I am committed to it because health of our fellow citizens. immunisation obligations at the end of 2019. vaccination is the great exponent of A Indeed, in order to take stock, we need to give our history and a symbol of the progress in I would like to start with a brief overview of children born after January 1 time to grow up medicine and the fight against obscurantism. the actions and steps taken since 2018. a little and benefit from the vaccines. Pasteur has blazed the trail that we are all walking on. Everyone can see that the I have proposed reforms that affect the daily The results are already noticeable, and the fight against vaccination is never safe from lives of our fellow citizens in a spirit of col- first immunisation coverage data for children opposing, still very dangerous, forces. lective and solidarity-based protection. born between January and May 2018, at the age of 7 months, is proceeding as expected. As soon as I took office, I made vaccination I am referring, of course, to the extension one of my top priorities. The choices and of the immunisation obligations to infants, For hexavalent vaccination, which, may I decisions I made were dictated by the context which was implemented as early as 1 January remind you, includes vaccinations against DTP, of vaccine hesitation and the resurgence of 2018, alongside a whole series of support tools and Heamophilus influenzae the epidemics we are facing. for the health professionals, parents and com- type B and hepatitis B, we have gone munities, including assistance in monitoring from 93.1% (compared with the same period It was also vital to place vaccination at the these obligations before children enter the in 2017) to 98.6%. forefront of the public space and to have a community; clear, strong and responsible public narrative. Vaccination coverage against meningo- I am also thinking of simplifying the vacci- coccal C infections with one dose is now It is therefore with the greatest pleasure nation process for people eligible for seasonal estimated at 75.7%, compared with only 39.3% that I am here with you today for a new flu vaccination since, from now on, anyone over the same period in 2017. We have clearly phase, the launch of European Immunisation going for their first vaccination will have the made significant progress here, too. Week 2019. choice to go to a nurse’s or pharmacist’s, in addition to a doctor’s or midwife’s practice; Vaccination coverage for the MMR vaccine 2018 and 2019 are two pivotal years in for children born in 2018 is not yet available which many milestones have been set for By the upcoming 2019-2020 season, because this vaccination begins at the child’s vaccination. Influenza vaccination by pharmacists will first birthday. But the vaccination rate also have been generalized. As everyone knows, progressed in 2018, from 85 to 87.2% for the Including vaccination as one of the priority increasing vaccination opportunities by sim- first dose, which was hoped for in the face of issues of the Priority Prevention Plan pre- plifying the process it is the best way to trigger the tragedies caused by the epidemic we expe- sented in March 2018 by Edouard Philippe is this collective effort on the part of our fellow rienced then and are still seeing with the 2019 a decisive support to this proactive policy. citizens. outbreaks. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 9

› The movement brought about by the reform With this new approach, a reference › An experiment is being conducted to of the immunisation obligations benefits vac- framework for pharmacovigilance is a nec- bring the professionals closer to the young cination in the broadest sense. essary prerequisite. This inventory will be with the aim of promoting and improving accompanied by data on the first 6 months the HPV vaccination coverage. The rate for the first dose of HPV vaccine of the implementation of the reform of the Finally, this year, Santé publique France will among 15-year-old girls, albeit still far too low, extension of immunisation obligations from conduct a nationwide survey in a number of has improved, rising from 26.2% for girls born January to June 2018. health facilities and EHPADs (residential estab- in 2002 to 29.4% for girls born in 2003. lishments for dependant elderly people) to While our first actions are already taking assess the vaccination coverage of the health In terms of parents’ participation, Santé shape, and in a positive way, many challenges professionals, and identify the obstacles to publique France has also carried out surveys still await us and we must restore confidence their vaccination against influenza. On this among parents of children under two years of and keep being vigilant. basis, we will launch in 2020 trial cooperation age. actions between professionals to promote the We face recurring clustered cases of measles; vaccination of health professionals. Parents’ opinions about the importance of and the latest outbreak has attracted the vaccination for children’s health is increasing interest of the media. These situations, which And I will conclude with a more compre- by +5 points (compared with June 2018). The mark the return to times and epidemics we hensive objective, to which the European perception of collective vaccination protection believed were over, are due to the inadequacy Immunisation Week is contributing: restoring is making progress in the same direction. of measles vaccination coverage, particularly confidence. among young adults. A slightly less positive figure: 47% of the Restoring confidence by talking about vacci- parents admit to being unfamiliar with the That is why the current measles epidemic, nation, restoring confidence by having a clear, immunisation obligations for infants. We, although less intense than in 2018 but still strong and responsible narrative. institutions and health professionals alike, worrying, needs to raise our awareness about must therefore keep up our collective efforts, the potential seriousness of this disease: it was Restoring confidence also by being there in terms of communication with and infor- responsible for one death early in 2019, and I where the French citizens get their infor- mation to the parents. would like to remind you that in 2018 three mation and by combatting misinformation deaths were linked to this disease. or disinformation. Fake news is a scourge, as Finally, the Collège de la médecine générale, rampant and dangerous as ever. in partnership with Santé publique France, This epidemic must also make us aware of interviewed a number of general practitioners. the need to protect ourselves against measles Health-wise, the European Union is also a in order to protect the most vulnerable. major field of action. Health is our common 99% say they are in favour of vaccination good, and Europe has a role to play. in general, and 75% of them perceive the Similarly, despite our efforts, the rate of extension of the immunisation obligations seasonal influenza vaccination among the Since September 2018, France has been as a positive step. I do not know whether the target population is 50%, a figure that remains coordinating a joint European action on vac- latter figure will increase, or whether it reflects well below the WHO target of 75%. cination. This action, which is planned over 3 the bitterness of having to exercise pressure in years, will strengthen cooperation and com- order to increase the immunisation coverage. I am also thinking of the vaccination against munication between all Member States in HPV. Initial activity data show an increase, order to have common tools at their disposal We are well on our way to achieve the col- but we are still a long way from achieving our and to fight, for example, against vaccine hesi- lective protection of the new generations, and goal. Preventing cervical cancer is yet a major tation or fake news. I cannot help but think that every point gained challenge. in vaccination coverage means fewer tragedies. Coming back to the European Immuni- We must therefore build upon this dynamic sation Week, I would like to stress that this I know that there are still parents out there and consolidate our foundations: event of general mobilisation extends beyond who fear the adverse effects of vaccination, our boundaries and gets the same message but the risks of not vaccinating a child are I have asked the Haute Autorité de Santé across everywhere to rally around the same infinitely higher. (HAS or High Authority for Health) to propose objective. changes for even simpler vaccine pathways, As I was committed to this for the sake and expanding the vaccination skills of the Our common objective of promoting vac- of transparency, to which I am very much health professionals will do just that; cination will have a new and very concrete attached, I will also present a pharmacovig- translation this year. ilance report at the end of the year. I also asked the HAS to extend the HPV vac- cination programme to young boys; The National Agency for the Safety of Med- icines and Health Products (ANSM) is working Experiments will also be conducted between with stakeholders and will present in June 2019 and 2020 to identify new means for 2019 a first progress report on the safety of action to promote vaccination. mandatory vaccines for children under 2 years ›› A project is underway to make vac- of age vaccinated during the years 2012-2017 cines available in doctors’ and midwives’ (i.e. before the implementation of the reform). practices, 1 0 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Dedicated supra-structural vaccination organizations: the driver of a successful vaccination schemes

5% by hospital services. (Groupe de réflexion Today, with a coverage of 97,2% Belgium is at scientifique Vaccinations, 2016) In Flanders the point of eradication. An obvious question a totality of 85.4% of the children were vac- is: why not make all vaccinations obligatory? cinated by Kind & Gezin, 9.5% by the pedia- trician, 4.4% by the general practitioner and An advice on the matter by the Belgian 0.7% by other authorities, for example vacci- Advisory Committee on Bioethics expresses nation programs overseas. (Vandermeulen C, a pragmatic and valuable approach regarding e.a., 2017) this question: “It is ethically unacceptable for a parent to deny his / her child a vaccine that In Flanders, Wallonia and Ostbelgien a is effective against a serious and preventable supra-structure of medical supervision works disease such as poliomyelitis or tetanus. On in schools themselves (CLB, PSE and Kaleido- the other hand, it is ethically acceptable to DG). Every two or three years each pupil refuse the vaccination of his / her child if the Maggie DE BLOCK visits this medical service. The visit of school balance of vaccination / disease risks is not sci- children to these facilities gives a unique entifically decisive. Parents must always make Belgian Minister of Social Affairs and Public access to vaccination. Flanders started with their decisions in the best interest of the child, Health and Asylum Policy and Migration HPV vaccination for girls through this medical and it is legally and ethically unacceptable for school supervision supra-structure in 2010, them to make decisions that are manifestly which led to a vaccination coverage of 90%. In to the detriment of their child.” (Belgian Wallonia this supra-structure was not offering Advisory Committee on Bioethics, 2015) This this possibility. Only approximately 35% of the conclusion undoubtfully will be used as a uccess and high participation in vac- eligible female target population is vaccinated. benchmark in the debate should the anti-vax cination schemes by the population Luckily since 2019 with new HPV-vaccines on movement keep growing. S is a multi-layered issue. A solid reim- the market, both in Flanders and Wallonia bursement regulation and the mere availability this supra-structure will now offer HPV- Summing up, making vaccination com- of vaccines will not guarantee that there will vaccination to all boys and girls. The coverage plementary by law, should be a last resort. be a high uptake or vaccination coverage. Two of vaccination against measles, is different However, when the public health is at stake, other equally important drivers to success are in the two parts of our country: in Wallonia such drastic measures need to be considered. the supra-structural organization responsible and Brussels, 75% of the adolescents are vac- The priority is to invest in common sense of the for vaccination and the legal framework cinated, while in Flanders 93% is vaccinated. A citizens and to ensure supra-structural organi- regarding vaccination. recent rapport (Devos C, 2019) on the Belgian zations that can facilitate and contribute to health system, showed however the necessity pro-actively vaccinate the population. Espe- First lets highlight how supra-structural that not only actions are needed to attain a cially in adult and older populations, there is organizations for vaccination can contribute high level of vaccination in children, but also a gap to fill. to a high coverage. By this we mean all facilities for the detection and vaccination of non-vac- that assure the successful functioning of a vac- cinated adults in order to prevent outbreaks. Bibliography cination program. In Belgium, the government guarantees access to vaccination for all Reaching the elderly is a challenge. How Belgian Advisory Committee on Bioethics. children. Three supra-structural organizations can we establish a dedicated supra-structure (2015). Opinion no. 64 of 14 December 2015 on oversee the administering of vaccines: Kind & to reach the elderly population easily in terms the ethical aspects of mandatory vaccination. Gezin in Flanders, ONE in Wallonia and Kaleido of pro-active vaccination? In contrary to the Brussels: BACB; https://www.health.belgium. DG in Ostbelgien. Working in close collabo- maternity wards and the schools where the be/en/opinion-no-64-mandatory-vaccination ration with the maternity department in the eligible target population flocks together, Devos C, C. A. (2019). De performantie van hospitals, these organizations assure basic vac- the major part of the elderly population is het Belgische gezondheidssysteem - rapport cination and the follow-up according to the scattered all over the geographical area, except 2019 Health Service Research (HRS). Brussels: vaccination scheme for young children set by for elderly homes. An interesting option to Belgian Health Care Knowledge Centre (KCE) the government. The presence on the field of study is whether a dedicated team in a home KCE Reports 313A. D/2019/10.273/32. this supra-structural organizations leads to a nursing service could take up this role similar Groupe de réflexion scientifique Vaccinations. vaccination coverage among newborn babies to the supra-structural organizations to ensure of over 93% in both Flanders and Wallonia for pro-active vaccination in this population. (2016). Enquête de couverture vaccinale en the most essential recommended vaccination. Wallonie. online: https://www.vaxinfopro.be/ A second driver for vaccination might be spip.php?article2000&lang=fr. In Wallonia nearly 55% of these vaccines are to make it compulsory by law. In 1966 the Vandermeulen C, e.a. (2017). Vaccinatiegraad given to children by the ONE, 35% by private Belgium government made poliomyelitis vac- in Vlaanderen in 2016. Vlaams Infectiebulletin, pediatricians, 5% by general practitioners, cination obligatory for each newborn child. 6-17. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 1 1 Promote vaccination, particularly the childhood immunisation programme and the HPV vaccine for both girls and boys

hpvalliance.ie), led by the Irish Cancer Society, to platforms. Information about vaccines on social promote the vaccine and regain parental trust. media can be misleading. I welcome efforts to The role of patient advocates in the Alliance direct parents to trusted sources of information was vital in connecting with the public. I would with the appropriate scientific advice which can particularly like to remember the contribution enable them to make the right choice to vac- of one such advocate, Laura Brennan, who sadly cinate their children. From an Irish perspective, passed away at the age of 26 in March this year I look forward to engaging with social media as a result of cervical cancer. Her legacy will be companies in the coming weeks and months the lives saved through her inspirational efforts to discuss what further measures can be put in to encourage girls to get vaccinated. Her work place to combat vaccine misinformation. and the work of everyone involved in the HPV Vaccination Alliance has seen uptake rates dra- The Role of the European Union matically improve to over 70%. In addition, from Cooperation between member states plays Simon HARRIS this academic year, boys in secondary school an important role in protecting the health of all are now able to avail of HPV vaccination which Europeans as infectious diseases do not respect Irish Minister for Health will further reduce HPV related cancer deaths in national boundaries. We have seen evidence of years to come. this with the rise in outbreaks of measles across “Misinformation about vaccines is Europe in over the past couple of years. as contagious and dangerous as the The Vaccine Alliance Within the European Union I would like to diseases it helps to spread.” Dr Tedros Regrettably, Ireland has experienced a drop especially commend the ongoing collaborative Adhanom, Director-General of the in the uptake of many of our other routine research on Vaccine Hesitancy. “The State of World Health Organisation, September childhood vaccinations over the past five years. Vaccine Confidence in the EU 2018” report 2019 This has been associated with recent national highlights the need to maintain high levels outbreaks of vaccine preventable diseases such of confidence in vaccination programmes to lobal life expectancy gains resulting as measles and pertussis and has highlighted achieve herd immunity but also underlines the from universal immunisation pro- the need for on-going vigilance regarding our complexities involved, including both individual G grammes represent one of the greatest childhood immunisation programmes. and environment factors that can influence achievements of humanity. The irony is that this In September this year I launched the Vaccine confidence. success can lead to complacency as we forget the Alliance which includes members from a wide At an international level I think it is important morbidity and mortality caused by diseases such range of health and civil society organisations. to recognise the role that transnational agencies as smallpox and polio in the past. In recent years The alliance will look to replicate and build on play in protecting us all. The work of the GAVI in Ireland we have had to face new challenges the good work done by the HPV Vaccination Alliance has seen huge strides being made in to vaccination confidence. Much work has gone Alliance. Their vison is to ensure all children in countries that would otherwise not be able to into restoring that confidence but undoubtedly Ireland are protected from vaccine preventable financially support and organise national immu- this work is not over. diseases and I will support them in whatever way nisation programmes. Similarly, the work of the I can to achieve this goal. WHO and of representative member states in HPV Vaccine Uptake Under Threat reacting to Public Health Emergencies of Inter- Chronic infection with Human Papilloma Social Media national Concern and preparing for future pan- Virus (HPV) infection causes cervical cancer, Although the absolute effect on vaccine demics is vital and I hope this work continues along with other cancers of the vulva, vagina, uptake is difficult to measure, I have no doubt and strengthens into the future. penis, anus, and oropharynx. A school-based that social media has played a role in under- programme of HPV vaccination for teenage mining confidence in vaccination. The dynamic Vaccinations save lives girls began in Ireland in 2010. It was initially nature of social media presents a new challenge Vaccinations have saved millions of lives since well received with an 87% uptake in the for maintaining confidence in immunisation they were first introduced towards the end of 2014-15 academic year. However, following a programmes worldwide. Misinformation on the 18th century, and we continue to improve coordinated anti-vaccination campaign this social media has the potential to spread and and strengthen our vaccination programmes plummeted to an estimated 50% in 2016-17. amplify in manner not seen before. However, with the introduction of more vaccines, like Anti-vaccine campaigners managed to utilise it also provides an opportunity to disseminate those against HPV and rotavirus, as they both traditional media and social media to information regarding the benefits of vaccines to become available. It would be a travesty to see spread misinformation about the HPV vaccine a wide audience especially younger generations this progress stall or regress, however there are with devastating effect. who are less inclined to use traditional media. worrying signs both in Ireland and in Europe. I The response to the drop in HPV vaccination It has been heartening to see that social therefore call on all member states to redouble uptake required a co-ordinated effort from a media companies have begun to recognise their efforts in maintaining robust childhood wide range of stakeholders. This included the the important role they can play in preventing immunisation programmes to protect the formation of an HPV Vaccination Alliance (www. the spread of vaccine misinformation on their futures of all children in Europe. 1 2 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e European Commission roadmap on vaccination

extensive vaccination campaigns. These cam- sources of information for the public, as well paigns save lives. In 2019 three EU Member as a European vaccination information portal States lost their measles-free status. There is to be launched next year. still work to be done. The Commission will support countering Vaccination is a safe and cost-effective online vaccine disinformation and develop way to protect people – especially infants evidence-based information tools and and young children – from certain infectious guidance for Member States in responding to diseases. Despite this, many children in Europe vaccine hesitancy. Communication on vacci- go unvaccinated and remain vulnerable to nation, explaining the myths, misconceptions potentially life-threatening diseases. The and skepticism that surround this issue will be key to preventing serious consequences as a priority for the next College. a result is to ensure that every community is Anne BUCHER not only prepared but also well informed that In the field of vaccine reserves, the Com- vaccinations protect the individual and those mission is considering a virtual European data Director-General DG SANTE, European around them. warehouse on vaccine needs, which could Commission facilitate the voluntary exchange of infor- At the EU level, our role is to assist countries mation on available supplies, possible surpluses in coordinating their policies and programmes. and global shortages of essential vaccines. This The European Commission has stepped up its would ensure that necessary measures are in action on vaccination, working closely with EU place in the event of a pandemic. ast September, during the Global Vacci- Member States and key partners in the global nation Summit in Brussels - co-organized community. In December 2018, the Council We also want to ensure, along with industry, L with the World Health Organization adopted a Recommendation to strengthen EU that a steady supply of vaccines is available, (WHO), I was particularly moved by the pres- cooperation on vaccine-preventable diseases. while ensuring a diversity of suppliers, and to entations of two of our participants: Ethan Moving forward, the European Commission exploit the possibilities of joint vaccine pro- Lindenberger, at the age of 18, went against his has set out a roadmap to ensure better coop- curement. Measures such as these are already mother’s anti-vaccine stance and inoculated eration among Member States. being rolled out. 15 Member States and the himself; and Kevin Brennan, whose sister Laura Commission have signed framework contracts Brennan died of cervical cancer this year aged Firstly, a feasibility study on the devel- for the production and supply of pandemic 26 after dedicating her last two years of life to opment of a common EU vaccination card influenza vaccines guaranteeing access to advocate for the HPV vaccine - which she had began this year, with a proposal for a common vaccines in the case of a pandemic. not received1 . What struck me most about vaccination document that could help EU both of these cases, was that they could – and citizens continue their vaccination across Recent years have shown us that the spread should - have been unnecessary. Member States, is expected in 2022. of contagious diseases do not respect borders. Europe has not only a responsibility to its Yet, these testimonies are crucial. According The Commission will continue the devel- citizens but to the global community as well, to a 2018 WHO/UNICEF report, vaccine opment of safe and effective new vaccines as evidenced by its work this year in central hesitancy has been reported in more than through Research programmes Horizon 2020 Africa. Thanks to close cooperation of Member 90% of countries worldwide, while according and the upcoming Horizon Europe. States and the European Medicines Agency to a recent Eurobarometer, 38% of Europeans (EMA), more than 1.5 million doses of a new believe that vaccines could cause the illnesses The bi-annual Report on the State of in the Democratic Republic of from which they protect2. Vaccine Confidence in the EU started in 2018. Congo have now been stocked. Its role is to monitor attitudes to vaccination Let us be clear - vaccines work. In 1980, the on a regular basis. Based on this, guidance that Together in the EU, we have built solid foun- World Health Organization declared smallpox, can support Member States in countering dations that will serve us well for success in the which once killed 400,000 in Europe each year, vaccine hesitancy will be presented by 2021. future. Let us keep up the fight to relegate to be eradicated. This was as a direct result of further diseases to history, and ensure that Information is key, in particular to coun- following generations no longer die from pre- teract the increasing trend on hesitancy in ventable causes, and avoid further speeches some of our countries. The European Centre like those of Ethan Lindenberger and Kevin 1 https://ec.europa.eu/health/vaccination/ ev_20190912_en for Disease Prevention and Control (ECDC) Brennan. will establish a European Vaccination Infor- 2 https://ec.europa.eu/health/ sites/health/files/vaccination/ mation Sharing system and provide guidance docs/20190426_special-eurobarometer-sp488_en.pdf for developing relevant and trustworthy E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 1 3 A cancer vaccine: how to eradicate virus-related cancers in Europe?

by 99%. These studies do not show any side phenomenon of mistrust of vaccines, largely effects that can be attributed to the vaccine. fuelled by significant disinformation about their risks and leading to a strong hesitation The European Centre for Disease Prevention from citizens regarding vaccination, in par- and Control (ECDC) therefore recommends ticular parents for their children. that Member States vaccinate girls aged 10-14 years with 3 doses. What can the European Union do?

However, the remains In order to respect gender equality regarding an exclusive competence of the Member diseases, and given the proven efficacy of vac- States. cination for male cancers, it is important to review ECDC’s recommendations for gender- The recommendations vary greatly from neutral programmes to include young boys. Véronique TRILLET-LENOIR country to country in the European Union: vaccination is recommended at different ages The European Union should also encourage Oncologist and MEP, Renew Europe, France, (from 9 to 26 years), most of the time only for an increase in the number of teenagers vac- Member of the ENVI Committee girls, at different doses (2 or 3 doses), and since cinated (ideally 90%) and guarantee fair 2017 it has been extended to boys in Italy, access to vaccination by preventing the risk of offered at school in Hungary and Ireland, free shortages. or partially reimbursed (France), etc. Last but not least, informing and educating ome cancers are virus-induced. Among Vaccination coverage is also very uneven: people is key in order to raise citizen awareness them, human papillomavirus (HPV), above 70% in Sweden, the United Kingdom, about the issues at stake. S responsible for sexually transmitted Northern Ireland, Spain, Portugal, Italy, cancers of the cervix, anus, penis, vulva and Malta, Hungary, Belgium, 50-60% in Finland, Updating European guidelines, working on the ENT region. the Netherlands, Denmark, Latvia, 30-50% hesitation regarding vaccination and setting in Germany, Slovenia, below 30% in France, up surveillance records for vaccine coverage The vaccine against the virus is effective: Luxembourg, Greece, Cyprus, Poland, Slovakia, should be part of a future European Cancer 26 studies conducted on 73,000 women and Romania and unknown in Estonia, Lithuania, Plan. which compare the risk of cervical cancer the Czech Republic, Austria, Croatia, Bulgaria. depending on whether or not they had been vaccinated with a follow-up of up to 8 years The gaps in coverage are due to a lesser have been compiled: the risk of developing extent to discrepancies in Member States’ lesions leading to cancer has been reduced recommendations than to a growing 1 4 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Clinical Evaluation of vaccines

In early clinical studies, the aim is usually pregnant women, to be included in the safety to determine safety and immunogenicity of database. the vaccine in a limited number of vaccinees, After approval, there is a need to make sure according to different doses and schedules, so that, vaccines are continuously monitored so to define the posology to be progressed into that emerging information on their benefit risk later clinical studies. Research geared towards balance is rapidly evaluated. To facilitate this, gaining more insight into the immune response risk management plans are put in place at time that confers protection after vaccination or of approval summarising, among other aspects, natural exposure would help in streamlining the the activities needed to gather additional development of new vaccines. In addition, new information on the safety of the vaccine. Effec- generation assays for both humoral and cell tiveness studies, that reflect real-world efficacy mediated immune responses could facilitate in terms of both the direct and indirect effect antigen(s) and regimen selection, and support of the vaccine, are in certain cases required as Prof. Guido RASI definition of correlates of protection with post-approval commitments. The existence of major impact on the development process. networks that can rapidly conduct safety and Director Executif of EMA In case there is no immune marker that effectiveness studies in the post-authorisation can be accepted as surrogate endpoint for phase would be instrumental for a timely and protection, and whenever possible, studies to efficient collection of these data. Collaboration determine the efficacy of the vaccine in pre- with public health authorities is often necessary venting the disease in the target population is to allow the conduct of these studies, which required. Depending on the incidence of the calls for a structured and transparent col- accines are arguably among the most infectious disease to be prevented, often these laboration among the different stakeholders. cost-effective and successful inter- randomised studies require large sample sizes, A platform that would enable the conduct of V ventions in public health. Regulatory in the order of the thousands, to meet the these studies across the EU would be of major authorities are responsible for evaluating study objectives. public health relevance as it would support vaccines prior to marketing authorisation For several diseases and pathogens, the more rapid and better-informed public health and continually monitor vaccines that are conduct of field efficacy trials is hampered by policy decisions on vaccination in Europe placed on the market to ensure requirements the relative rarity of cases that can be recruited through knowledge sharing and utilisation of for quality, safety and effectiveness are met. in a reasonable timeframe. In such instances, common methodologies. At the same time, Robust and established criteria for evidence provided feasible and scientifically adequate, it would also facilitate rapid and robust regu- to be generated during vaccine development approaches such as human challenge studies, latory decisions on individual vaccines. are in place and illustrated in dedicated up to or inferring protection from animal models of Overall, provision of greater assurance on date guidance documents issued by EMA. EMA disease, have been proposed. More in-depth the robust evaluation of vaccine safety and also offers the possibility of scientific advice to understanding of these models and their sur- vaccine effectiveness, would improve public discuss elements related to a specific vaccine, rogacy is needed to help regulators in deter- confidence in vaccines and vaccination moni- that cannot be addressed by guidelines. mining their value across the different devel- toring programmes. opment phases. Indeed, the growing phenomenon of Several new vaccines are currently under Late stage clinical trials usually provide vaccines hesitancy is negatively affecting vac- development. These cover pathogens for which major contribution to the safety database of cination campaigns in many countries in the a vaccine is not yet available or pathogens for the vaccine. Besides standard requirement for EU and elsewhere in the world, with detri- which current options may provide further the safety evaluation of medicinal products, mental consequences on the ability to protect improvements. In order to efficiently advance adverse events of special interest following citizens and save lives due to the spread of the development of these vaccines, it has been immunisation are proactively collected in vaccine preventable diseases. Regulators have advocated for a more conducive environment the clinical trials. The actual size of the safety a major role to play in improving transparency to foster vaccines research and development in database at time of approval may vary for each and providing easily accessible way infor- the EU and retain the current vaccines expertise vaccine depending on the identified potential mation on vaccine product ingredients and and infrastructure. risks. However, in principle the database should the assessment of quality, safety and efficacy, Innovative technologies such as nucleic be sufficiently large to estimate the frequency including safeguarding their scientific integrity. acids and viral vectored vaccines, including of uncommon adverse events (occurring in- The collaboration with ECDC, health care heterologous prime-boost strategies, or alter- between 1/100 and 1/1000 vaccinated persons). professionals and other authorities around native routes of administration such as needle- Depending on the vaccine and the target popu- the world, to raise awareness on safety and free mucosal administration, are emerging lation, there is a need to consider the number effectiveness of vaccines, and the creation of approaches requiring where an understanding of subjects in the target population within a an EU vaccination portal to proactively share of the underlining science is needed to establish certain age range or belonging to any special information on vaccines and vaccination in the regulatory requirements. population, e.g. immunodeficient subjects or EU, are important steps forward in that regard. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 1 5 Improving pan-european collaboration in tackling vaccine-preventable diseases

closely together at the pan-European level. in evaluating the evidence base, and lead Whilst each country is responsible to organise to greater opportunities for sharing good and deliver healthcare to its citizens, it makes practice and expertise. ECDC will also assess sense to facilitate information sharing and to the feasibility of developing guidelines for a pool knowledge and best practice around vac- core European vaccination schedule, and work cination between Member States. to improve vaccination coverage monitoring systems. Following a 2018 Council Recommendation on strengthened cooperation against vaccine- Building trust preventable diseases, the European Centre The reasons why people are not getting for Disease Prevention and Control (ECDC) vaccinated are manifold and complex. ECDC is embarking on a new journey in the fight is helping to build and regain trust in vacci- against vaccine-preventable diseases. One nation by providing credible information to Andrea AMMON important task is to lead a new collaboration healthcare professionals, policymakers and between European public health and immuni- also the wider public. One more step in that ECDC Director sation experts. It provides a forum for experts direction is the ongoing development of an from EU Member States and countries of online European vaccination portal to provide the European Economic Area (EEA) to come evidence-based information on immuni- together and discuss current priorities, issues sation - in plain language that everyone can and best practices. understand.

f you could easily protect yourself from This new collaboration builds on existing Vaccines have brought tremendous health harm – wouldn’t you? Taking the example structures – so called National Immunisation benefits to our world – much more than I of vaccines, we see that they have led to Technical Advisory Groups (NITAGs), that are we often realise. ECDC is therefore com- significant reductions in the number of cases established in most European countries and mitted to strengthening Europe’s defences of many diseases. Smallpox, for example - once whose scientific assessments form the basis of against vaccine-preventable diseases, and will the deadliest disease known to humanity - national recommendations around vaccines. continue to help Member States build con- has now been completely eradicated. Polio is These NITAGs, or equivalent expert com- fidence and trust around vaccines. present in only a handful of countries, and the mittees, provide decision-making bodies with number of cases of measles and rubella are but evidence-based advice to ensure that local a fraction of what they once were. policy is well informed with the latest scientific knowledge. But despite these major achievements for public health, outbreaks of vaccine-pre- Improved national ventable diseases such as measles continue decision-making to occur across Europe, due to insufficient The collaboration between the different numbers of vaccinated people in many NITAGs, facilitated by ECDC, will enable countries. The target for measles elimination the sharing of published and unpublished in 2020 will be missed, and measles vacci- evidence generated at national level through nation coverage has fallen steadily over the last an online platform and through a series of ten years. False claims about immunization webinars. It will also serve as a system for threaten to undermine public confidence countries to work together in synthesising the in the safety and efficacy of vaccines, and evidence on vaccines and their use in immuni- are being spread on the internet and social sation programmes through conducting joint media. In addition, several European countries reviews of the latest evidence, and through have experienced shortages in vaccine pro- the development of mathematical models on duction and supply, which has hampered the vaccination. effective implementation of their vaccination programmes. The result of such close exchange of knowledge and practice will ideally lead to Facilitating exchange between EU more transparency, efficiency, effectiveness Member States and consistency in the national decision- There is no simple answer how to address making process on vaccines and immuni- these challenges. But many of them can be sation policies. It should also reduce the dupli- tackled more effectively if we work more cation of work that exists across countries 1 6 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Sustain vaccination programmes through a healthier vaccine ecosystem in an interconnected Europe

Corinne BARDONE, Pharm D Christina KLEIN Florence BARON-PAPILLON, Pharm D Head of Global Vaccines Public Affairs, for Manager, Global Vaccine Public Affairs, Head of Public Affairs Europe for Vaccines, Polio, Pertussis and Hib containing Vaccines, Sanofi Pasteur Sanofi Pasteur Sanofi Pasteur

ince the emergence of vaccination, life Continuing in the path of progress The global vaccine ecosystem comprises a expectancy has increased between 15-25 for immunisation is dependent on large variety of actors, including the European S years, and further gains are expected. a healthy vaccine ecosystem. actors, both at regional and country levels, Evidence suggests that the control of Over the last decade, the vaccine ecosystem notably EU Institutions, Member states gov- infectious diseases through vaccination largely has proven to be vulnerable, with increasing ernments, healthcare professional associations, contributed to this increased life expectancy. risks of unbalances, the most visible being vaccine manufacturers, patients’ groups, as Many infectious diseases, which were once vaccine shortages. illustrated in figure here below. commonplace, are increasingly rare because of vaccination. Take smallpox, for example – an infectious disease which killed hundreds of Vaccine Ecosystem International / European Public Health Institutions Organizations millions of people globally. It is now eradicated Interdependancies chart (WHO / ECDC.) thanks to vaccination, and we are on the verge of eradicating polio. National procurement Vaccine Ecosystem International / European Public Health bodies R&D based vaccine manufacturers Trade Despite the tremendous progress made, Institutions MediaOrganizations Associations Interdependancies chart (WHO / ECDC.) (IFPMA, EFPIA, there are major trends of the global public Vaccines Europe.) heath context directly impacting the vaccine Health National authorities / Vaccine Immunisation Technical MoHs National procurement Ecosystem Advisory Groups ecosystem: (NITAGs) bodies R&D based vaccine ›› Growing/ aging world population which manufacturers Trade HCP groups Employees Media (physicians, Associations challenges both national health structures pharmacists, (IFPMA, RegulatoryEFPIA, nurses, etc.) EU Institutions Vaccines Europe.)agencies (EU Commission, (EMA, National and budget agencies,etc.) Health EU Parliament)National ›› Infectious diseases still being major public authorities / Vaccine Immunisation Technical MoHs Ecosystem Advisory Groups Local communities (NITAGs) Neighbors, schools/ health threats, with still circulating infec- Patient & universities tious agents, like polioviruses or measles, Citizens’ groups Other 3rd parties / HCP groups Employees despite existing vaccines and continuous (physicians, civil society pharmacists, Regulatory Think tanks evolution of bacteria and resulting nurses, etc.) EU Institutions agencies (EU Commission, (EMA, National in new emerging diseases (Ebola, Zika…) EU Parliament) agencies,etc.) ›› Urbanisation and increasing migration Local communities and displaced populations from areas of Neighbors, schools/ Patient & universities conflicts, which raise new vaccine preven- Citizens’ groups tion challenges to be addressed, including Other 3rd parties / civil society for Europe. Think tanks E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 1 7

high volume and low price. They spend on average 2% of their annual income in R&D, some even benefiting from donors’ or gov- ernment’s funding for their manufacturing infrastructures. Over the last decade, the concentration of R&D based manufacturers was observed, with, consequently, shrinkage of R&D investments for new vaccines against new diseases. Only five companies are carrying out 63% of the most urgently needed vaccine R&D projects2.

In addition, decisions for industry to invest in Europe are increasingly challenging as incentives are much higher in other ter- ritories like Singapore and the USA. Further loss of vaccine manufacturing capacity and capabilities in Europe would have direct con- sequences for the European population, with progressive loss of control over its own vaccine supply and over its biodefence. Europe would then become reliant on imported vaccines supplies and in the event of epidemics or even more worryingly, a pandemic or a biological attack, EU Member States will find themselves competing with non-EU countries for available vaccine supply, risk losing out, as local manu- facturers might prioritize their home markets Each of the actors of the ecosystem has its price criteria resulting from governments and geopolitical partners. This should raise own role and is impacted by the behavior of and public health partners willingness to concerns knowing infectious diseases evo- the others, among others: minimize vaccine budget. lution risks and the antibiotic resistance › ›› For regulatory agencies, to set guidelines › Limited visibility on the vaccines demand: context. for high quality, safe and efficient vaccines knowing that it takes up to 3 years to ›› For the EU and National public health in- produce vaccines, a 1-year tender con- Invigorating the vaccine eco- stitutions, to define vaccination policies/ tract does not allow us to anticipate the system is critical to sustain vac- programmes according to the epidemi- manufacturing. cination programmes › ology, existing vaccines and their benefit- › Highly specific national regulations Fortunately, we see encouraging EU initi- risks at population level creating delays to vaccine access. For ex- atives on vaccination (i.e. Council Recommen- ›› For the procurement agencies, to plan ample, to reach a Chinese baby, a vaccine dation and the Joint Action on Vaccination) and procure vaccines based on the de- lot manufactured in Europe is tested 3 that demonstrate the strong commitment mand, the immunization programme and times and sometimes with different test from Europe to stay at the forefront of vac- the budget defined by the governments methods or norms. cination policies & innovation, and lay the ›› For the manufacturers, to develop and These global trends are damaging for the groundwork for a necessary ‘healthier’ vaccine produce vaccines with the required vaccine industry, mainly the R&D based ecosystem. Supply & preparedness to health quality and regulatory standards, and vaccine manufacturers ‘species’ including the threats, fight to stop vaccine misinformation supply countries according to demand ones based in Europe. We produce vaccines dissemination, HCP coalition on vaccination signals. that have been researched for worldwide pop- are critical topics that contribute to set up a ›› For the healthcare professionals (HCP), to ulation, investing massively in development policy climate supportive of a European-based implement vaccination policies and get of vaccine and large-scale manufacturing vaccine industry, with continuous investments target populations vaccinated accordingly biotechnologies as well as manufacturing in R&D and in manufacturing capacity for a ›› For the population, to access reliable and infrastructures/ facilities. An average of 16% of sustainable supply of high-quality vaccines. accurate information on vaccination they our income is spent in R&D of new vaccines, In a few months, Germany will take the EU need complying with highest level of standards of presidency fora a semester, and the European evidence generation (eg. Efficacy Randomised Health Data Space appears to be one of their Because of these high interdependencies, Controlled Trials involving thousands of priorities. Digital transformation of healthcare major impact on one “species” can put at risk patients1). systems has the potential to boost R&D and the ecosystem balance, with consequences In comparison, the emerging countries innovation in vaccines. Not only it will open such as reduced access to vaccines/vaccination vaccine manufacturers produce mainly a new era in vaccine innovation, but it will globally and reduced Research & Development heritage vaccines for the emerging world that also create opportunities to accelerate clinical (R&D) investments in new vaccines. were researched and developed by the R&D- based manufacturers, with a clear focus on Indeed, still today, we too often see: 2 2018 Stat+ - Access to Medicine Foundation ›› Cost-containment policies and tender report https://www.accesstomedicineindex.org/ processes-based solely on the lowest 1 https://clinicaltrials.gov/ct2/show/NCT01427309 publications/2018-access-to-medicine-index 1 8 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e

development of new vaccines or new indi- between 0,5 and 1 billion Euros. As a result, that demonstrates the power that integrated cations and to reduce the related costs, while the private sector can no longer develop new electronic health registries can have on vaccine assessing the real-world impact of vaccines vaccines at risk, without any visibility on a evaluations, allowing better understand the thanks to the electronic health registries. possible return on investment. performance of vaccines in a real-world envi- Interesting new solutions approaches have ronment, helping to demonstrate the value Sanofi Pasteur is contributing and com- emerged as either public-private partnerships. of a vaccine, and providing insights for future mitted to engage with all vaccine ecosystem These are new sources of value sharing, vaccines development. actors to address the key challenges that coordination and cooperation for the world, require coordinated efforts. as for instance for the usage of electronic Conclusion ›› Sustainable supply and procurement health data. Sanofi Pasteur is committed to As recently mentioned by Professor Panos practices R&D open innovation, notably via Innovative Kanavos ‘In order for the vaccine ecosystem to Sanofi Pasteur has a strong legacy in Medicine Initiative (IMI) projects (eg. Antimi- be “healthy”, all relevant stakeholders should be vaccines and produce vaccines against 7 crobial resistance, healthy ageing, pertussis) taken into account’3…, including the vaccine bacterial diseases and 8 viral diseases. More in Europe and contribute to the ongoing industry. than 1 billion doses of vaccines are produced discussions on the new Horizon Europe each year in 12 sites, in France, North & South 2021-2027 framework. Moving forward, we should maintain America, and Asia. ›› Use of electronic medical records in new dialogue and jointly seek common solutions We all concur on the fact that poor fore- vaccine development for: casting, inappropriate procurement mech- The development of a new vaccine clas- ›› a more balanced and healthier vaccine anisms and increasing regulatory barriers are sically requires from 10 to 15 years with ecosystem, in order to tape the full po- impacting ability to supply vaccines to the massive investment ranging from $200 million tential that vaccination has both on the population. to $1 billion (including construction of manu- sustainability of the European healthcare At Sanofi Pasteur, we have conducted facturing facilities). systems, and on releasing pressure on its our own assessment of the roots causes that Convinced by the fact that digital health health care resources. impact our capacity to supply our vaccines data opens a new era in vaccine, Sanofi Pasteur ›› a favorable environment for vaccine through a specific company initiative to is supporting the Northern California Kaiser industry investments in R&D and manu- improve supply security and we have action Permanente (NCKP) vaccines research unit in facturing in the EU countries, that provide plans in place to optimize our Industrial affairs the conduct of an unprecedented, innovative similar incentives than other attractive processes accordingly. In parallel, we actively real-world evidence clinical study to evaluate regions contributes to the existing collaborative work the relative effectiveness of different flu ›› an interconnected Europe that facilitates within the trade associations at global and EU vaccines available in the US. patient electronic medical data collection, levels (IFPMA & VE), with regular interfaces The data used are generated during routine including vaccination records, and ena- with WHO on this topic. Optimising public clinical practice within the NCKP healthcare bles interoperability of health information procurement practices and better demand system in the US, using their integrated systems to connect data, for the benefits anticipation is also central in our discussions digitalized patient record system enabling the of public health and vaccines innovation. with Health Authorities at National levels. tracking of influenza events, complications ›› Continuous investment in vaccine in outpatient and inpatient facilities and This would contribute to a healthier Europe, Research, development & Innovation vaccination status. The novel approach of where ‘no one should die or suffer from a As R&D remains Sanofi Pasteur’s DNA, we this pragmatic study allows the prospective vaccine-preventable disease’ and to reduce are investing more than 500 million euros each inclusion and cluster randomization of a total cross border health threats. year, with five R&D sites (Europe and North of 1.6 million vaccinees over two years – which America) and employees representing 15% of would, have never been possible in the tradi- the overall Sanofi Pasteur’s staff. tional setting. However, due to drastic evolution of Similarly, we have just started a similar regulatory standards and requirements for pragmatic randomized controlled database 3 Professor Panos Kanavos (associate professor LSE) pre-clinical and clinical trials, the cost of devel- trial in partnership with the Finnish Institute during the European Health Policy Forum Gastein opment (R&D, global licenses) and industrial of Health and Welfare (THL). This study https://www.euractiv.com/section/health-consumers/ equipment for a new vaccine is estimated possible in a European country is one example special_report/a-healthy-vaccines-ecosystem/1388050/ E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 1 9 Looking ahead to the next decade for immunization in Europe

diseases that vaccines can prevent, more must be done in the Region to systematically identify the root causes leading to these coverage gaps and to devise effective responses in a tailored way to close them. Immunization as a platform to provide other pertinent healthcare benefits, including the role of immunization in contributing to financial risk protection against health costs, will posi- tively contribute to the concept of attaining Universal Health Coverage by the countries in the Region. With EVAP coming to an end in 2020, a strategic agenda for the next decade Dr. Siddhartha DATTA Ms. Catharina de KAT to amplify the efforts of countries to improve vaccination coverage and thereby protection Programme Manager, Vaccine-preventable Communications, Web and Information against vaccine-preventable diseases in every Diseases and Immunization programme, Officer, Vaccine-preventable Diseases and community will give achievement of Universal WHO Regional Office for Europe Immunization programme, WHO Regional Health Coverage a healthy boost in the Region. Office for Europe A European strategic agenda for immuni- zation for the next decade, developed by the accination is widely recognized as one elimination or eradication of vaccine-pre- countries in Region, will outline strategic focus of the most successful public health ventable diseases. Realistic regional goals, areas to address the root causes of gaps in V interventions ever developed. Vaccines including sustained polio-free status and vaccination coverage in every community in have been responsible for the eradication of measles and rubella elimination, laid out the Region. The strategic focus areas will allow smallpox and rinderpest, near eradication of together with enabling objectives, such as further strengthening of immunization systems polio, control of several other once ubiquitous financially sustainable immunization pro- to comprehensively reach everyone so that diseases and untold millions of saved lives. Yet grammes, have served as a roadmap to achieve countries can attain and sustain the disease their full potential for preventing diseases and this vision. elimination and eradication goals of the Region thereby contributing to society in broader In 2018, at the midpoint of EVAP, a detailed in the next decade. Building on the principles ways, from preventing lost days at school, review was conducted to assess progress based enshrined in EVAP and insights gained through savings in healthcare costs, lost wages and on identified targets and milestones. What its implementation, the starting point for this productivity due to illness to reducing the risk this review found was a mixed picture. Overall new strategic agenda will be equity – every of antimicrobial resistance, has not yet been coverage increased, to 91% for the first dose person in the European Region should have realized. With the end of European Vaccine of measles-containing vaccine in 2018, for the same quality of opportunity to enjoy the Action Plan 2015-2020 (EVAP) approaching, example, but not by enough. Progress made in benefits that the existing and future vaccines this is an opportune moment for the countries some countries did not match that in others: offer. Innovation and partnerships at all levels in the European Region to reassess progress middle-income countries that lack any external will be key to achieving this. and design a path forward that will help ensure donor funding or support were especially The new European regional immunization the people of the European Region enjoy both lagging behind in terms of achieving the vac- strategy will contribute to the strategic pri- optimal use of and the full benefits of vaccines. cination coverage targets and providing their orities outlined in Immunization Agenda In 2014, all 53 Member States of the WHO populations with the benefits of newer vaccines. 2030, a new global strategy for immunization. European Region (Region) unanimously Measles coverage in the European Region as By aligning itself to the principles of primary committed to do more in the area of immu- a whole is the highest in the world (together health care, the new regional strategy will be nization and agreed on a set of key goals for with the Western Pacific Region), yet measles anchored in a “people at the centre” approach their national immunization programmes. In and rubella elimination will, most likely, not to developing national policies. addition to setting priorities, EVAP is a tool be achieved during the life of EVAP and large The strategic focus areas in the new strategy for the national immunization programme measles outbreaks have swept through com- will be guided by national priorities and based managers to lobby decision-makers for munities and countries, killing over 70 people on local data and evidence. National immuni- adequate programme funding; for ministries in 2018 alone. zation stakeholders will thus be in the driver’s of health to benchmark and compare their The ongoing measles outbreaks in the Region seat, both in development of the regional progress to that of other countries; and for affecting even countries with high reported strategy and in its national adaptation and populations to gain better protection against immunization coverage expose dangerous implementation. Only in this way can the new vaccine-preventable diseases. immunization gaps in individual and com- regional immunization strategic agenda apply EVAP centers on a vision of what can be munity protection against this and other to all peoples, all nations and all institutions in achieved through vaccination – the control, vaccine-preventable diseases. To stop the the Region. 2 0 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Securing a robust vaccine sector in Europe

immunisation programs still significantly a concerted and coordinated effort by all differs within Europe3. Moreover, only a few stakeholders. countries start to account for the change in demographics that we are all experiencing with Vaccine manufacturers strive to anticipate many Vaccine Preventable Diseases (VPDs) and respond to production issues and to remaining uncovered due to insufficient continuously improve production processes, budget provision. When it comes to investing invest in new sites or expand the existing in healthcare, we should ask ourselves whether ones. A quick response to increased demand the balance is right. is most of the times not feasible due to the long vaccines production lead times and to Vaccines are a distinctive product for a the time needed to increase capacity. Since number of reasons. First of all, they are a pre- the production of vaccines involves biological vention tool administered to a large number processes, the manufacturing of one lot of Magdalena RODRIGUEZ de AZERO of healthy people which is affecting the ben- vaccine takes between 12 months for mono- valent vaccines and more than 36 months for Executive Director, Vaccines Europe efit-risk assessment. Secondly, compared to other medicines, vaccines are highly technical some complex multivalent vaccines. Up to 70% biological products with complex and lengthy of that time is dedicated to quality control. The manufacturing, control and release processes, increase of production capacities through the construction of a new plant may take between starting from live micro-organisms to end with accination certainly constitutes one 5 and 10 years from inception to production safe and sterile products. These special features of the most cost-effective preventive and release of the first vaccine lot. mean that the development and production measures existing today and a foun- V of vaccines are particularly time-consuming, dation of public health programmes in Europe In contrast to the broader pharmaceutical demanding, complex and costly and expose it and worldwide. Vaccines play a fundamental industry, the global vaccine market is limited to numerous risks for disruption. role in reducing the morbidity associated to a to relatively few manufacturers. It is due to number of diseases, including certain types of the manufacturing complexity of biological More broadly, the vaccine industry con- cancer and chronic conditions. Vaccines are products, the need for significant investments also part of the solutions to reduce antimi- stitutes a strategic sector for the European up front to develop new products, building and crobial resistance. Today, there is a vast range economy. Europe has a long history of vaccine maintaining the facilities, and guaranteeing the of vaccines available to protect against more discovery, development and manufacturing, quality of the product with increasing regu- than 30 infectious diseases – and there are new and benefits from a strong industrial infra- latory requirements. All this, together with a vaccines on the horizon with the potential to structure. While major innovative vaccine cost-driven policy that does not sufficiently prevent even more. manufacturers are global in nature, many of incentivise research and development efforts, their operations are based in Europe. 80% of makes the vaccine industry a “fragilised” sector. Vaccination, therefore, makes a substantial vaccine doses produced by Vaccines Europe We have seen that some European countries contribution to health, healthcare systems, (VE) members are being manufactured in the have divested national vaccine manufacturing and society at large, and health is the cor- European region and 86% of these doses are (e.g. Rijksinstituut voor Volksgezondheid en nerstone for a competitive economy. However, exported for worldwide use4. Guided by the Milieu (RIVM) in the Netherlands and Statens health systems are still largely built on treating constant pursuit of innovation, the vaccine Serum Institut (SSI) in Denmark), and the same illness, not promoting health. In Europe, the industry scores a 16% of revenues invested is happening in the private sector with com- overall spending on primary prevention and in research. This high rate of investment is panies leaving the vaccine space6. vaccination is relatively low compared to 50% greater than the software and computer overall healthcare spending: on average, less services5. Keeping Europe’s lead in such a key This is worrisome and, in this context, a well- than 3%1, and 0.5% of Member States’ total sector and ensuring that European citizens balanced vaccine ecosystem, which recognises healthcare budgets respectively is dedicated benefit from the value of vaccination requires the true value of current and future vaccines to immunization programmes.2 The number of as well as the strategic value of the EU vaccine publicly funded vaccines included in national industry is absolutely critical. What can we all 3 https://www.sciencedirect.com/science/article/pii/ do together to make sure we keep Europe at S0264410X18308727?via%3Dihub the centre of vaccine research and manufac- 1 Gmeinder M; Morgand D;Mueller M (2017). How 4 https://www.vaccineseurope.eu/about-vaccines/ turing in the future? much do OECD countries spend on prevention? vaccines-europe-in-figures/ https://www.oecd-ilibrary.org/docserver/f19e803c-en. 5 Data provided by WifOR Institute is based pdf?expires=1569405811&id=id&accname=guest&che on the 2018 EU Industrial R&D Investment cksum=6744C8AF05558BA46D9F2FB79CEBD486 Scoreboardhttps://publications.jrc.ec.europa. 6 https://www.pharmaceutical-technology.com/ 2 Olivier Ethgen & others https://www.ncbi.nlm. eu/repository/bitstream/JRC113807/eu_rd_ news/newsgsk-pharma-completes-acquisition-of- nih.gov/pmc/articles/PMC4994728/ scoreboard_2018_online.pdf novartis-healthcares-vaccines-business-4683437/ E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 2 1

The research-based vaccine industry in Europe continues to be committed to 1) * invest in future vaccines and capacity building, to 2) seek efficiencies and innovative solutions to further improve manufacturing and supply, and to 3) work with National and European authorities and stakeholders on the solutions proposed in the Council Recommendation on strengthened cooperation against vaccine- production sites preventable diseases and the Joint Action on Vaccination, especially on research, devel- opment and improving sustainable supply of vaccines in Europe and globally.

In addition, Vaccines Europe recommends (1) to address the lack of a stable policy envi- ronment to support vaccine innovation with Europe appropriate pull mechanisms, together with North America a fair recognition and reward of vaccines Asia Rest of the world value, (2) to continuously interact with all stakeholders from the earliest stages of devel- opment – especially regulatory authorities and * recommending bodies to ensure that resources are not spent on developing vaccines that are unlikely to be approved and recommended, (3) to better connect and coordinate vaccine research while also focusing on research for diseases of low-income countries and pandemic preparedness to better anticipate and prepare for future health threats, which is one of the greatest challenges of our time (4) to keep the right balance between treatment and prevention when it comes to investing in healthcare and to account for the shift in demographics in Europe within the national immunisation plans.

Keeping Europe’s lead in such a key sector is crucial if the EU does not want to become reliant on imported vaccine supplies and A LEADER IN THE R&D OF INNOVATIVE VACCINES* ensure that European citizens benefit from the value of vaccination.

*

Pneumococcus,

healthcare expenditure. (cf. ref. Back cover B .1)

(cf. ref. Back cover B .2)

VACCINATION PROTECTS PATIENTS WITH CHRONIC DISEASES E.g. Influenza vaccination

Hepatits B vaccine.

715 000 lost days of work and productivity thanks to Influenza vaccination.

SOCIETAL BENEFITS

PROTECTING YOURSELF IS ALSO ABOUT PROTECTING OTHERS

? 2 2 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Harnessing the power of partnerships to develop life-saving vaccines

public-private partnership (PPP) between the technologists to ensure public acceptance of European Union and the European pharma- the local campaigns through educational and ceutical industry. outreach programmes.

Vaccine research lends itself well to the PPP Within our Ebola portfolio there are model because there are many areas where projects focused on rapid diagnostics which there is a need for collaboration between are badly needed for this disease. It is so industry, academic researchers and others to important to be able to detect as quickly as create multi-stakeholder groups that have possible whether people presenting with the expertise, data and resources to address symptoms have Ebola (in which case they major gaps and solve challenges in vaccine need to be isolated) or another illness. Four research and development. Only by working IMI projects are dealing with this issue and together in this way can we hope to accelerate have mobilised laboratories in Europe and Dr. Pierre MEULIEN the time from the research bench to clinical Africa as well as small biotech companies and assessment in humans. the diagnostic industry to provide creative Executive Director, Innovative Medicines solutions. Currently several of the resulting Initiative (IMI) Over the past 11 years of IMI we have prototypes have been approved to be used in invested over EUR 430 million (from public, field trials in the current DRC outbreak. private and philanthropic sources) in 17 projects covering a whole host of issues. The We have another project called ZAPI IMI vaccine portfolio can divided roughly into (‘Zoonoses anticipation and preparedness two main chapters. The first includes projects initiative’), which brings together experts covering general bottlenecks in vaccines R&D, in human and animal health to create new including ways of assessing vaccine efficiency, platforms and technologies that will facilitate t is universally well accepted that vacci- manufacturing quality, and vaccine safety, for a fast, coordinated and practical response nation is one of the most effective lifesaving example. The second is about how Europe to new infectious diseases as soon as they I public health interventions the world has as responded to the pandemic threat of Ebola in emerge. The project has chosen three viruses its disposal. So far, two mammalian diseases 2014. that have been known to make the leap from have been officially wiped out through vac- animal to human. These are Rift Valley fever cination campaigns. Smallpox, which plagued Spotlight on Ebola (usually infecting cattle, sheep, camels and the human race for thousands of years (it was goats), Schmallenberg virus (cattle sheep and responsible for about 400,000 deaths in Europe When the Ebola crisis broke in Africa in goats), and Middle East Respiratory Syndrome every year in the 18th century) was officially 2014, there was no vaccine, no rapid diag- (MERS, whose usual reservoirs include bats eradicated in 1980. Rinderpest, which caused nostic, no anti-viral therapy; in short, nothing and camels). infections in cattle, buffalo, antelope, deer and that we could offer patients or those at risk related species, was eradicated in 2010. in order to squash the epidemic. The IMI Addressing some of the biggest Governing Board reacted immediately by challenges in vaccines research Many other diseases have been and are allocating a significant budget and launching being controlled today through massive vac- a series of Calls for proposals for European The other part of the IMI vaccine portfolio cination campaigns worldwide. These include and African groups to accelerate research on deals with some hot topics in vaccinology. , tetanus, polio, some forms of men- vaccines, rapid diagnostics, manufacturing For example, while we know a lot about how ingitis, otitis, whooping cough, pneumonia, platforms and clinical trials platforms. To antibodies neutralise incoming pathogens, hepatitis A&B, measles, rubella, mumps, date, we have invested over EUR 300 million we know a lot less about how cellular chicken pox, influenza and others. in this area and the resulting IMI projects immunity works, and what potential markers have been spectacular in how they have of immunity could be in different settings. Europe plays an important part in securing enabled valuable implementation in the Here, IMI’s FLUCOP project is looking at many the production of these vaccines. Indeed field. One vaccine went from bench to the immunological parameters to decipher which 80% of the world’s vaccines are produced on clinic within one year, while another project markers correlate with a protective response European soil and we can also boast some of worked on analysing the immune responses to flu vaccines. The results of this project the best groups involved in vaccine research to another Ebola vaccine both in Europe are currently being used to design future and development in the world. and Africa. Three rapid diagnostics are being influenza vaccines and could help us design field-trialled as we speak and manufacturing the ultimate universal flu vaccine. This is one reason why so much vaccine at scale strategies have been worked out in oriented research is funded through the yet another project. The project teams have We are also looking at vaccine safety as the Innovative Medicines Initiative (IMI), a also been working with social scientists and bar for safety in vaccination is set extremely E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 2 3

high - and for good reason - as vaccines are used mostly in prevention strategies and Introducing IMI therefore intervening in healthy populations where safety should be paramount. Thanks to The Innovative Medicines Initiative (IMI) our projects, we now understand much more was set up in 2008 as a public-private part- about the human and how to nership between the European Union (rep- harness this optimally in order to maximise resented by the European Commission) the desired immune response against a and the European Federation of Phar- specific infectious agent while minimising the maceutical Industries and Associations risk of adverse events. (EFPIA).

Taking action on vaccine For 2014-2020, IMI’s total budget is hesitancy EUR 3.276 billion. Of this, EUR 1.638 billion comes from Horizon 2020, the EU’s funding Finally, we need to address the issue of programme for research and innovation. vaccine hesitancy in Europe. There has been EFPIA companies have committed EUR a lot of misinformation coming from the anti- 1.425 billion to the programme, and up vaccine lobby which needs to be countered by to EUR 213 million can be committed by evidence based data covering the other organisations that decide to con- of disease in Europe and the positive impact of tribute to IMI as Associated Partners in the use of vaccines. IMI’s ADVANCE project’s individual projects. 47 partners come from 19 EU countries and include the vaccine industry, the European At IMI, our goal is to improve the med- Centre for Disease Prevention and Control, the icines development process and make it European Medicines Agency, national public more efficient, and to ensure that patients health laboratories and academic experts. will have faster access to better and safer The project has delivered a blueprint of an medicines. We do this by funding collabo- efficient and sustainable vaccination benefit- rative projects that bring together all key risk assessment tool that is acceptable to all groups involved in life science research. stakeholders. This is a major achievement and Through our projects, we are funding provides a platform for solid monitoring of the innovative solutions to the most pressing benefits and safety of vaccines. medical burdens of our time, including antimicrobial resistance, dementia, and Recently ADVANCE has driven the creation diabetes. of a not-for–profit international organisation called VAC4EU. Its goal is to provide, in a con- Over a decade in, we are globally rec- sistent and stable manner, the evidence that ognised as a pioneer of open innovation the European citizen and policy makers have and an attractive model for successful been asking for. Hopefully this will increase the public-private partnerships (PPPs) in confidence that the EU citizen has in vaccines research. so that we can together avoid dramatic situations like the recent explosion of cases of Interested? Find out more at imi.europa.eu measles in 47 European countries, solely due to a decrease in vaccination rates. We have a collective responsibility to share solid evidence on the benefits of vaccination so that our populations can remain immunised against the most deadly diseases that historically had such a devastating impact on our societies. 2 4 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Vaccination, Population Health, and European Leadership

savings as populations continue to age. All of these health benefits, as well as vaccination’s economic and social benefits, are magnified by vaccination’s ability to interrupt the transmission of disease, offering some protection to the unimmunized—a phenomenon known as “herd effects.” Chief among vaccination’s economic benefits is its protective effect for labor force participation, hours, and productivity. When people remain healthy, they are able to work more and with greater vigor, translating into increased household income and savings, as well as, at the macro level, reduced fiscal stress. In a similar fashion, vacci- David E. BLOOM Daniel CADARETTE nation for post-retirement adults can allow them to be more productive in non-market activities, Harvard T.H. Chan School of Public Health Harvard T.H. Chan School of Public Health such as volunteering in the community or helping Boston, Massachusetts USA Boston, Massachusetts USA to raise grandchildren. And at the other end of the age spectrum, children who are vaccinated accination coverage in Europe is high aging and the associated mounting burden of non- are able to attain higher levels of schooling with in both historical and comparative per- communicable diseases. fewer absences and even enjoy greater cognition in V spectives. Based on available data, coverage The aforementioned benefits of vaccination are comparison with their unvaccinated counterparts. for all antigens recommended for routine immuni- widely recognized and reflected in the methods Vaccination also helps reduce risk for households zation by the World Health Organization (WHO)1 used to assess both existing and new vaccines for and improves peace of mind. has increased or remained at high levels over the determining inclusion in national immunization Finally, vaccination’s social benefits include last one to two decades. For most of these vaccines, programs. However, in recent years economists boosting social equity, insofar as the protection Europe is at or near the top of the list for coverage and the global health community have come to afforded by vaccination tends to disproportionately in comparison with other geopolitical regions of recognize that vaccines confer myriad benefits advantage less-well-off members of society. Within the world. beyond direct reductions in morbidity, mortality, households and families, vaccination also has inter- Although there are myriad causes of morbidity and health care costs. These benefits (which must generational effects; the human papillomavirus and mortality, it is not a coincidence that vaccine also reflect any adverse effects due to vaccination) vaccine, for example, improves the odds that coverage is high in Europe and life expectancy is fall into three categories: additional health benefits mothers will survive and be able to care for their also long. In fact, life expectancy at birth in Europe not typically assessed or measured, economic children. has increased five years since 2000 and is higher benefits, and social benefits. Rational, well-informed decisions about the than in any other WHO region. Europe’s high life One broad health benefit of vaccination that has allocation of social resources need to account for expectancy is due in part to having the world’s gained prominence in recent years is its ability to all of the sources of benefit vaccination offers, lowest mortality rate for children under the age of help slow and mitigate the effects of mounting anti- which appear to be substantial from accumu- five—to which pediatric vaccination indisputably microbial resistance—a major threat looming over lating evidence. In principle, most of the health, contributes—and is further bolstered by high the future of Europe and the world. Vaccination social, and economic impacts of vaccination can longevity for adults who have reached the older both directly reduces the incidence of resistant be measured, monetized, and summarized in the ages—to which adult vaccination contributes. infections and indirectly curtails resistance by form of a social benefit-cost ratio. The models Europe’s deep commitment to vaccination diminishing the need for antimicrobial treatment, and tools to accomplish this are well established, coverage has also relieved some pressure on its which is what drives the development of resistance and in the European context we have much of health budgets. Prevention of infectious disease in the first place. At the individual level, vaccination the data required to generate estimates in a rea- via vaccination has an important offsetting effect can help prevent cascading health problems, such sonably rigorous fashion. Assessing vaccination’s with respect to rising health care costs. Some of as secondary nosocomial infections that might full benefits will be especially relevant for funding the steady creep in health spending in recent years take hold when an unvaccinated individual is hos- decisions with respect to a new generation of is due to the market entrance of new, expensive pitalized for a vaccine-preventable disease. Some vaccines currently in the pipeline (such as those for treatments and procedures. Costs are further vaccines, such as the , are hypoth- clostridium difficile and respiratory syncytial virus), magnified by the pressure imposed by population esized to protect against “immune amnesia” in which are likely to be more expensive and have a which infection with one virus makes a child more moderately greater immediate budgetary impact vulnerable to other potentially fatal infections. than earlier-generation vaccines. European policy- 1 The WHO recommends vaccination against Vaccination can also protect early childhood devel- makers would do well to keep the full benefits of tuberculosis; hepatitis B; polio; diphtheriae, tetanus, opment, which has been linked to improved health vaccination in mind in decisions looming on the and pertussis; Haemophilus influenza type b; pneumococcal disease; rotavirus; measles; rubella; and outcomes later in life; at the population level, this horizon and continue Europe’s impressive record human papillomavirus for all immunization programs. will eventually lead to considerable health care cost of leadership in the vaccines space. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 2 5 Raising awareness about the importance of vaccination in Europe for public health

Conducted surveys have shown that 85 % were during this year placed by World Health of EU citizens considered vaccination as an Organization among the top 10 threats effective instrument how to prevent infectious to public health. These data confirm that diseases. Around 50 % of Europeans vaccinated effective awareness rising and combat against in the last five years and almost 80 % of EU the disinformation is necessary for the efforts citizens are discussing the possibilities of vac- to increase the level of vaccination. We need cination with health care experts, whom they to support further research regarding the trust. On the other hand 48 % of Europeans improvement of vaccines and the need to mistakenly believe that vaccines can often ensure equal access to vaccines for all. We also cause serious side effects and 38 % think have to support health workers and empower vaccines can cause them the diseases they are them so that they can build on trust that originally protecting them from. 34 % do not people have to them. They are the frontline see the need to be vaccinated and 29 % think when it comes to vaccination and are helping Monika BEŇOVÁ vaccination is only necessary for children. to increase vaccine acceptance and counter vaccination myths. MEP (S&D Group), This is one of the results of disinformation Member of the ENVI Committee campaigns focused on vaccination, which

accination can surely be considered as a great success. It helped to almost V exterminate such diseases as measles, smallpox, whooping cough or diphtheria that hurt or killed millions of people in the past. Vaccination saves up a huge amount of human lives every year. It also provably offers an important protection for the youngest and oldest members of our society, as well as for those people who due to their health condition cannot be vaccinated and are most vulnerable to illness. Vaccination is the crucial part of our modern public health care systems. It not only saves human lives, but also reduces health care costs.

Unfortunately, vaccination has become the victim of its own success. Suppression of some diseases started to be taken by society as for granted and society than mistakenly stopped feeling the risk of those. It is still true that diseases that can be prevented by vaccination still pose a great risk. People also have become more concerned about possible side effects of vaccination. The result is that there are doubts about the need to vaccinate and the level of coverage decreases which leads to the weakening of herd immunity.

Confidence in vaccines is crucial. Decisions of individuals not to vaccinate, affects the whole entire population. The fact is that if we want to continue in eliminating diseases and aim to protect people who cannot be vac- cinated, because they are too young, too old or too sick, we all need to vaccinate. 2 6 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Is Europe Prepared for the Future of Vaccines Innovation?

Dr. Emmanuel HANON Dr. Rino RAPPUOLI Dr. Philippe DENOEL Senior Vice President, Head of R&D, GSK Chief Scientist, GSK Vaccines Head of External R&D, GSK Vaccines Vaccines

Introduction New Vaccines Will Bring Unprec- deeper understanding of how the human edented Health Benefits immune system interacts with pathogens. ach year, vaccines help protect people Advancements in vaccinology, immunology, With a new generation of adjuvanted vaccines of all ages worldwide against nearly 30 and new technologies have the potential to we will be able to target populations with E vaccine-preventable diseases. Second fundamentally change the dynamics of vaccine sub-optimal immune responses, including only to clean drinking water, vaccines save development by enabling us tackle new disease older adults at risk of developing diseases like more lives (around 2-3 million) than any other targets previously believed out of reach, and to respiratory syncytial virus (RSV) and Chronic public health intervention. Vaccination plays a test, manufacture, and deliver vaccines faster. Obstructive Pulmonary Disease (COPD), and fundamental role in helping to protect people Moreover, these breakthroughs highlight new people living in developing countries and from diseases that would otherwise decimate opportunities to expand protection offered by exposed to global killers like tuberculosis and communities and weaken societies. That is vaccination for all stages of life, a concept we Malaria. why vaccines are widely seen as one of the call “lifecourse immunisation” [see Figure 1]. These new technologies open opportunities best investments in healthcare that any gov- Promising new technologies include antigen for a step-change in vaccine discovery, and ernment can make. delivery platforms like GSK’s self-amplifying will help expand new fields of vaccine devel- mRNA (SAM), generalised modules for opment. For example, the area of therapeutic The recent life science revolution, the membrane antigen (GMMA), and bioconju- vaccines is growing and has great potential for exponential growth of new insights into gation, which can potentially speed up dis- patients. GSK is already working on vaccines host-disease interactions, and the discovery covery, increase potency and efficacy, simplify for patients suffering from chronic diseases like of disruptive technologies are enabling us and accelerate manufacturing, and reduce Hepatitis B infection, which can lead to liver to re-think vaccinology and to develop new scale-up time and costs to make vaccines cancer,1 and COPD, a debilitating respiratory vaccines we could not have imagined even a accessible to broader populations. Adjuvants – few years ago. Unlocking this potential means substances designed to enhance the immune we are on the verge of developing vaccines response to vaccines – also create new possi- 1 Hepatitis B Foundation. Risk Factors for more diseases and populations, faster and bilities. Adjuvants have been used in vaccines for Liver Cancer. https://www.hepb. more efficiently than ever before. since the 1930s, but today scientists have a org/research-and-programs/liver/ risk-factors-for-liver-cancer/. Careful preparation is required to fully realize the potential of tomorrow’s vaccines. Many current challenges related to devel- opment, licensure, and administration of vaccines must be overcome. Now is the time to for Europe to lead the way to ensure suc- cessful development of the next generation of vaccines and delivery to patients who need them. Figure 1. The Transformation of Vaccine Innovation E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 2 7

disease that is becoming more prevalent The Horizon Europe and new health inno- research. CHIMs are particularly needed for globally.2 In addition to therapeutic vaccines, vation partnership programs offer a timely the development of universal or broadly pro- we are also setting our sights on vaccines that opportunity to build upon this successful tective vaccines against influenza, RSV, andC. address antimicrobial resistance (AMR), a model for the future. To build a true part- difficile. growing threat to public health and modern nership, we urge European Institutions to Finally, we recommend expanding beyond medicine.3 For example, GSK has begun clinical move beyond the current structure where mainly disease-driven IMI projects toward studies for a vaccine against an often-devas- the role of industry is often limited to a con- projects that encompass technology-oriented tating infection with bacteria called C. difficile, tributor rather than an integral partner in the research, including vaccine adjuvants, platform a major cause of gastroenteritis-associated process of bringing vaccines to the market. As technologies, antigen discovery, and systems- illness, antibiotic use, and death worldwide.4 we have demonstrated, industry brings unique immunology. By doing this, Europe will more expertise, experience and capabilities that quickly open new fields of vaccine devel- Europe Can Play a Lead Role in significantly contribute to innovation, and opment like therapeutic and AMR vaccines for the Transformation of Vaccine therefore should be integrated as a key partner patients throughout the life course. Innovation across the spectrum of R&I activities. Europe is poised to drive the transfor- 3. Foster a Competitive and Innovation- mation of vaccine innovation. The EU-funded 2. Commit to Transform & Accelerate Friendly Environment for Vaccines and multi-stakeholder led Innovation Part- Vaccine Development nership for a Roadmap on Vaccines in Europe A supportive and innovation-friendly (IPROVE), outlines the science and technology Given the rapid progress in life science and R&I environment is essential to drive the investments required for vaccines innovation vaccine technologies, concerted action is development of new vaccines. Europe has a and charts a scientific course forward.5 GSK needed to realize the full potential of future long history of leading the world in vaccine contributed to this roadmap and we remain vaccines. Constant innovation is needed in discovery. Today, the vaccine R&I and manu- a committed partner to implement its vaccine development, which is complex and facturing footprint in Europe is substantial. objectives. In this spirit, we offer the following currently takes as long as two decades or Continuous investment in vaccine research, recommendations for a stronger European more.8 To accelerate the critical pathway from development, and production represents a vaccine research and innovation (R&I) discovery to delivery, we need to transform major public health strength and economic enterprise: research, development, and licensure. asset for Europe. The IPROVE roadmap identified a need for Ensuring a competitive and innovative 1. Build Upon the IMI Partnership Model a multidisciplinary approach to vaccinology. vaccine development and manufacturing By harnessing analytical tools and data sources landscape requires commitment to policies Europe has led multi-sectoral partnerships available today and in the future, we can that drive private sector investment. This in public health and medicine with the Inno- identify targets and reach decision points requires an appropriate balance between vative Medicines Initiative (IMI1 and IMI2). faster, by exploiting our rapidly evolving “push” mechanisms (e.g. capacity, capability, Now in its second decade, the IMI has built understanding of microbiology, genetics, funding, tax incentives and infrastructure) and an unparalleled network of public and private immunology, structural and systems biology, “pull” mechanisms (e.g. clear target product researchers who have translated basic immu- and bioinformatics. profiles, more predictable and stable demand, nology insights into tangible vaccine devel- We also need to take a closer look at clinical and improved procurement policies). More opment milestones.6 With 13 IMI projects on trials to identify opportunities to modernise fundamentally, it requires a viable and sus- vaccines, GSK and other vaccine companies and streamline whilst maintaining the highest tainable pricing and access environment have contributed substantially to major safety standards. The IPROVE roadmap calls for vaccines in Europe. Policy change will advancements in vaccine R&I in Europe and for innovative design and harmonisation of require sustained political will, but will ensure beyond.7 clinical trials data and development of analyses Europe remains a global leader in this vitally- frameworks, including use of novel analytical important sector. tools to streamline data collection during trials 2 Quaderi, SA and Hurst, JR. The unmet global and profile volunteers earlier in the process. Conclusion burden of COPD. Glob Health Epidemiol Genom. Advances in immunology, disease modelling, We are on the brink of a new era of vaccines 2018; 3:e4. Available at, https://www.ncbi.nlm.nih.gov/ in silico modelling, including the analysis of big in which the scientific and technological pmc/articles/PMC5921960/. data and the application of machine learning advances across the life sciences will revolu- 3 Toner E, et al. Antimicrobial resistance is a global and artificial intelligence, provide opportu- tionise vaccine development. To fully enable health emergency. Health Security 2015 13:3 153-55. nities to innovate, de-risk and accelerate the the potential of future breakthroughs, a https://www.liebertpub.com/doi/full/10.1089/ vaccine-development process. clear scientific roadmap of actions has been hs.2014.0088. In addition, more effort and collaboration proposed that would improve the way vaccines 4 Abt Mc, MKenney PT, Pamer EG. Clostridium are needed to develop controlled human are evaluated, licensed, used, administered, difficile colitis: pathogenesis and host defence. Nature infection models (CHIMs) which are especially monitored, and financed. The European Insti- Reviews Microbiology 2016; 14:609-620. Available at, helpful for the development of vaccines and tutions are positioned to be at the forefront of https://www.nature.com/articles/nrmicro.2016.108. can provide early evidence of clinical efficacy this transformation. What is needed now is suf- 5 A strategic European roadmap for the vaccines of and samples for cutting-edge immunological ficient political drive to enable this ambition, tomorrow: a joint stakeholder reflection. March 2016. including implementation of appropriate legal, Available at, http://iprove-roadmap.eu/wp-content/ uploads/2016/06/IPROVE-ROADMAP_JUNE2016_ economic and structural measures that will 8 International Federation of Pharmaceutical WEB.pdf. best incentivise, reward, and accelerate vaccine Manufacturers & Associations (IFPMA). The complex innovation in Europe. 6 Denoel P. et al. Impact of Innovative Medicines journey of a vaccine: the steps behind developing Initiative on vaccine development. Nature Reviews a new vaccine (2019). Available at, https://www. Drug Discovery 2018; 17:769–770. ifpma.org/wp-content/uploads/2019/07/IFPMA- 7 Ibid. ComplexJourney-2019_FINAL.pdf 2 8 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Vaccination for patients with chronic conditions

therapy that weakens it. Patients with auto- about the benefits and risks of vaccination immune conditions, or people with organ specifically for them, i.e. understanding the transplants, sometimes cannot be vaccinated benefit/risk of each vaccine in their personal at all, so they depend even more than other context, including the risk of not being vac- people on effective community (herd) cinated, so that they can make an informed immunity. Those patients are put at particular decision that is right for them. risk by the falling rates of vaccination in the population. The EPF Manifesto on vaccination for patients with chronic diseases calls for action The European Patients’ Forum started to improve patients’ access to vaccination, engaging its membership on this topic in 2018, as well as better targeted information. Vac- first by conducting a short survey to explore cination should be included in disease man- awareness and attitudes to vaccination, and agement plans and clinical guidelines, and pro- Marco GRECO then by producing a toolkit of information and fessionals should routinely check their adult advocacy resources. Three national workshops patients’ vaccination status and offer vacci- President of European Patients’ Forum (EPF) have been held – two in Romania, and one nation if needed. Patients’ barriers to access in Germany. Our work has highlighted some vaccination in different countries, including issues, including: patients’ lack of awareness availability and cost, should be tackled. of specific recommendations for their chronic condition; vaccination not being integrated Patients are also concerned about low properly as part of the treatment pathway; vaccination uptake and hesitancy among accination does not just concern some degree of hesitancy in the patient com- healthcare professionals. Inconsistency or children: it is something that benefits munity; and practical access barriers such as negative attitudes can undermine the trust V people of all ages. A life-course availability and cost. relationship between patient and healthcare approach to vaccination as part of universal professional, so it is vital that professionals health coverage can enhance people’s quality Patients look to both traditional and give a consistent, solid, evidence-based of life, including that of people living with increasingly social media for information. message across professional groups, and set an chronic diseases. For society and governments, Many say there is not enough easy-to-find, example. The EPF believes that developing col- there may be significant savings for health and trustworthy and easily understandable infor- laborations between healthcare professionals’ social systems from reducing the burden of mation on vaccination for specific chronic and patients’ organisations in this regard is a chronic as well as vaccine-preventable diseases conditions. Patients also want to know more vital step forward. – for example by avoiding unnecessary hospital admissions through better management of chronic conditions in the community and by reducing the impact of antimicrobial resistance and thus costs associated to it. Vac- cination should thus be considered a part of universal health coverage.

Vaccination is particularly important for patients with chronic diseases and long-term health conditions, such as diabetes, respiratory illness and heart failure. Their numbers are increasing, especially as people become older. Many of these patients are at higher risk of catching infectious diseases; complications of common infectious diseases can be much more serious for them. Vaccination recom- mendations exist for many conditions, but the uptake of vaccination by patients is lower than it could be.

In addition, some patients are vulnerable either because their immune systems are weakened by disease or they are undergoing E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 2 9 Vaccine hesitancy: public health emergency

One of the main reasons behind this Changing the public perception of vac- resurgence is a rising tide of vaccine scep- cination must be a priority and social media ticism. Europeans are not convinced anymore giants have a big role to play in clamping down about the safety of vaccination and some on fake news and disinformation. They need think it is not necessary to vaccine as the to take responsibility and start promoting diseases appear to be ‘gone’. According to this credible sources of information and verified, year’s Eurobarometer, a third of unvaccinated evidence-led and scientifically credible Europeans do not see the need for vaccination. awareness campaigns. As for the awareness, 48% of surveyed agreed with a false claim that vaccines can produce It is also necessary to reverse the negative serious side-effects and more than one third of trend of the public health funding cuts respondents falsely believed that vaccines can enacted over the past decade. Resources need cause the disease against which they protect. to be put behind empowering healthcare Rory PALMER professionals, including midwives and school How did we get here? In recent years, social nurses, with funding, information and training MEP (S&D Group), Member of the ENVI media has become a “breeding ground for mis- in order to improve expertise and increase Committee leading information and negative messaging uptake in under-vaccinated communities. around vaccination”. This is the conclusion reached by the UK’s Royal Society for Public WHO declared vaccine hesitancy is one of Health. Thanks to platforms like Facebook false the main threats to global health.. We need to claims around the possible side effects of the get all actors on board to tackle it - decision radicating and tackling disease and vaccines spread further and faster than ever and policy makers, healthcare professionals, protecting public health through vac- before, despite strong scientific evidence that organisations, communities, social media E cination is one of the most important those fears are false. These platforms could platforms, the media and citizens - working achievements of modern medicine. Next year become even more influential as generations together to provide comprehensive and we will celebrate the 40th anniversary of the that have grown up with these platforms accessible information. global eradication of smallpox, a disease which become parents. had been one of the world’s most feared Choosing not to vaccinate puts everyone at diseases. Moreover, thanks to the national The good news is that healthcare profes- risk. It is the vulnerable who are put at most vaccination programmes Europe is free of sionals still remain the most trusted source risk by falling vaccination rates - newborn polio since 2002. Despite successes like these, of vaccine information for parents and they babies, elders, cancer-treated patients whose we have been seeing an unwelcome return play a vital role in making parents aware of the immune system is weakened, or those without of some of the vaccine-preventable diseases. importance of childhood vaccinations. Unfor- a fully-working immune system. This is a Today, we finds ourselves on the verge of a tunately, public health budgets have been hit public health emergency, the EU’s response global public health emergency. severely by the austerity measures in the last must treat it as such. decade. As an example, the county of North- amptonshire in my constituency, local public Measles is one such example. Since a vaccine health budgets have been cut by 15% between was introduced in the UK in 1968, 20 million 2016/17 - 2018/19. Such decisions have long- cases and 4,500 deaths have been averted in lasting impact on access to health services and the UK, according to Public Health England the health of local populations, specifically (PHE). The UK had successfully managed to when it comes to disadvantaged and socially achieve World Health Organization measles excluded groups. elimination status, but shockingly that status has now been lost. Diseases do not recognise borders, that is why the EU needs to show leadership on this. This is a part of a global trend. In recent Vaccination programmes might be a com- years we have been seeing record-breaking petence of national and local authorities, but measles outbreaks across Europe, even though they vary from country to country, creating a the disease is almost entirely preventable with confused and incoherent picture at EU level. just two vaccination doses. Over 82 500 people The EU has the power to advocate for a com- were infected in 2018 - 3 times higher than prehensive and harmonised approach to vac- in 2017 and 15 times the number of people cination and to strengthen cooperation and affected in 2016. coordination. 3 0 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Resilient immunisation systems: looking beyond high vaccination rates

among the top 10 global health threats for contribute to the growing body of evidence 2019, alongside other major health challenges, related to the safety of vaccines. Nothing is such as climate change, non-communicable more important to us than the safety of our diseases, antimicrobial resistance and Ebola.2 In medicines and vaccines. September, the European Commission in col- Vaccine hesitancy is creating a number laboration with the WHO, organised a Global of concerns for those of us who are com- Vaccination Summit. A major focus there mitted to addressing public health issues. was how we can rebuild trust in vaccination, One of these concerns is the effect hesitancy which is a key factor in addressing hesitancy. has on adherence. By adherence to immu- The Summit ended with the adoption of an nisation programmes we mean access to Action Plan3, which, unfortunately leaves a vaccination in due time, based on national lot to be desired in terms of concrete follow recommendations. Ensuring the full course up, measurable goals and operational clarity. of the vaccination programme is delivered is Sibilia QUILICI Undoubtedly, there is political will to fight critical to benefit from the full potential of vaccine hesitancy, but we also need political vaccination. Take, for instance, the example of Public Policy Director, MSD leadership and alignment across the multi- measles, which requires two doses. Adhering sector stakeholders involved in the devel- to the programme schedule and adminis- opment, implementation and delivery of a tering both doses is critical to ensure the successful immunisation programme. vaccine’s immunity protection. To solve the In addressing vaccine hesitancy, we all problem, we need immunisation systems have our part to play. Our role as the inno- that have strong infrastructure for adequate s national health budgets are under vative pharmaceutical industry is to research, surveillance and monitoring, we also need continuous pressure, the importance develop, manufacture and distribute vaccines to run public awareness campaigns, provide A of successful immunisation systems to address some of the most challenging adequate training to healthcare professionals, becomes critical. However, we need to look public health concerns; infectious diseases and improve access. If all of this is achieved it beyond just achieving high vaccination rates which have the potential to put the health of will contribute greatly to the resilience of the and ensure resilient and sustainable immuni- all citizens at risk. Some of those most at risk programme, build public and professional sation systems are established which positively include high risk and immunocompromised confidence and increase uptake. contribute to public health long term. So, where populations. These are the populations which does one begin? rely on the community immunity achieved Creating a resilient immunisation through large population immunization. But programme Responding to hesitancy inventing and developing vaccines is complex, In addition to the issue of hesitancy, a major Vaccines are one of the most cost-effective time-sensitive, and carries no guarantees. It barrier to sustained high vaccination coverage and successful public health interventions requires an ability to produce hundreds of and trust in immunisation programmes lies available. They help prevent diseases, save lives, millions of doses of high-quality vaccines – in the inability of our healthcare systems to and improve social and economic well-being and ensure the same quality in every single properly prepare for and respond to crises. across the globe.1 However, vaccine hesitancy dose, every single time. An example of this is the recent measles threatens the global progress we have made As we develop new vaccines, we think years outbreaks in Europe. This crisis has focused in combatting the spread of many serious and ahead to anticipate and lessen hesitancy: attention on the need to start looking beyond preventable infectious diseases. For this reason, Beyond conducting clinical trials to improve just increasing vaccination coverage rates, it is now becoming more important than ever safety and efficacy, we are considering the and towards taking a more comprehensive that we protect the hard-fought immuni- type of information people need to promote approach by building resilient immunisation sation gains, and ensure they are sustained. We confidence and reduce hesitancy when these systems. have to work towards delivering high-quality vaccines become available. In addition, we A resilient system is able to recover or vaccination services through resilient systems, keep investing to meet the demands of new or “bounce back from adversity” following the which are well resourced, delivered through expanded immunisation programmes around experience of negative events, threats or the life-course of citizens and which are inte- the world, which in turn, leads to an increased hazards.4 At its core, this concept of resilience grated into the wider national health system. global demand for vaccines. Through the is rooted in planning for the successful A few months ago, the World Health Organ- sharing of our scientific work we continue to isation (WHO) identified vaccine hesitancy 4 WHO-EURO. Building resilience: a key pillar of Health 2020 and the Sustainable Development Goals 2 https://www.who.int/emergencies/ Examples from the WHO Small Countries Initiative. 1 https://www.who.int/immunization/sage/ ten-threats-to-global-health-in-2019 2017. http://www.euro.who.int/__data/assets/ meetings/2014/october/SAGE_working_group_ 3 https://ec.europa.eu/health/sites/health/files/ pdf_file/0020/341075/resilience-report-050617- revised_report_vaccine_hesitancy.pdf?ua=1 vaccination/docs/10actions_en.pdf h1550-print.pdf?ua=1 E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 3 1

sustainability of the programme but also d. Capable, implying the possession of a to wider populations. However, this creates a quick recovery in the face of a challenge. broad range of skills, assets and resources significant complexity in the system. The com- Resilience is a state where an issue does not to meet its needs. plexity is mirrored in the variety and numbers have an opportunity to take hold. It is where e. Self-regulating and thus able to quickly of actors involved: from individual and com- an issue or threat can be isolated quickly, dealt isolate threats and minimise threats to munity groups, to healthcare professionals, with and managed without it affecting the essential services. advisory bodies, public health institutes and immunisation programme or other parts of Building resilient immunisation systems policy makers to name just a few. In addition, the health system. is key to sustaining high vaccine uptake and other “non-traditional” actors and platforms Recent research5 6 suggests that you can helping communities prevent, manage and which share information on vaccination, such characterise a resilient immunisation system recover from hesitancy-related issues. Finding as social media platforms and religious leaders as: better ways to anticipate and prevent such further add to the complexity. a. Aware and therefore able to identify issues will protect both individual and public Acting together, each component of this emerging risks, system weaknesses and health. The worrying rise in vaccine hesitancy vaccine ecosystem has the potential to col- strengths and is in a position to map out is threatening to reverse the remarkable laborate and strengthen the resilience of the strategies for engaging strengths and re- decades-long gains made by vaccines. immunisation system. ducing weaknesses. Therefore, building and sustaining resilience Understanding how to build a resilient b. Integrated and thus ensuring recognition in immunisation programmes is now critical. and sustainable system by engaging all stake- and coordination between key system Take, for example, the case of France, which holders, respecting their interrelationships and sectors. in January of 2018 introduced mandatory vac- what roles they play in an immunisation pro- c. Adaptive, indicating an ability to change cination in an effort to address the worrying gramme may therefore be key to promoting to better position itself to succeed in drop in vaccine coverage rates. They identified the resilience of successful immunisation warding off crises, or mitigating threats, the issue and took action to address it dem- programmes. when they do occur. onstrating bold leadership to safeguard public It is time for the EU institutions and health. However, the bigger question is why Member States to start investigating how trust in vaccination and the immunisation to build and sustain resilient immunisation system had dropped so low that this measure systems by firstly assessing the vulnerabilities was required. and strengths within member states. Ensuring 5 Kruk ME, Ling EJ, Bitton A, et al. Building resilient resilience assessment indicators are developed health systems: a proposal for a resilience index. BMJ The need to work together and used in a harmonised way across the (Clinical research ed) 2017; 357: j2323. Over the past few decades immunisation European region is a good place to start. This 6 Kruk ME, Myers M, Varpilah ST, Dahn BT. What is programmes have expanded as a result of the should be central to the work already started a resilient health system? Lessons from Ebola. Lancet introduction of innovative new vaccines and under the EU Vaccination Roadmap going (London, England) 2015; 385(9980): 1910-2. new evidence which demonstrate the benefits forward.

Supportive, Positive Community & Individual Experiences

Addressing vaccine hesitancy and creating resilient immunisation systems require a multi-pronged approach Resilient & Sustainable Immunisation systems

Government & Effective Health Stakeholder Systems, Policies & Programme Leadership and Coordination Commitment (incl. private sector)

@ MSD 3 2 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Raising awareness about the key role of health professionals - The role of physicians in vaccination

At the same time doctors and other Role of the European Union and healthcare professionals have faced a new European umbrella organisations challenge to tackle the declining coverage European policies should support healthcare rates, not only in the EU, but across the whole professionals and empower them to provide world. Healthcare professionals play a crucial effective, transparent and objective infor- role in delivering facts based on scientific mation to the public and fight false and mis- evidence and increasing public awareness leading information. The EU could undertake about the benefits of immunisation. Doctors Europe-wide awareness campaign(s) on vacci- are often the most trustworthy source of vac- nation, propose common EU wide vaccination cination information and therefore important schedules and support education to improve advocates to drive vaccine acceptance. communication on immunisation. EU actions should however be done under consideration However, there is evidence that some of different settings in different member states. Prof. Dr Frank Ulrich MONTGOMERY doctors and healthcare professionals feel ill- equipped to answer questions or engage in The Standing Committee of European President of the Standing Committee of difficult conversations on vaccination, par- Doctors (CPME) is co-chairing a new Coalition European Doctors (CPME) ticularly with reluctant patients and parents. for Vaccination together with the European In addition, healthcare professionals’ own Federation of Nurses Associations (EFN) and confidence in vaccination is not always high. the Pharmaceutical Group of the European Union (PGEU). This Coalition gathers around Education about vaccination facts 20 relevant European healthcare profes- t’s a shame: People are still dying of vaccine- and vaccination myths sionals’ and students’ associations to commit preventable diseases that should no longer Education of medical students is essential to delivering accurate information to the I exist in Europe. Some of them were already to enable new doctors to effectively com- public, combating myths and exchanging best supposed to be eliminated but the rise of municate with their patients. Currently, practices. The Coalition members can poten- disinformation on vaccination, particularly education about vaccination during medical tially outreach to millions of healthcare profes- online, the decline of people’s confidence in school is not yet optimal in all European sionals, as many of them are major European vaccination, and inadequate access to vaccines countries. Vaccination should also be better umbrella organisations. have led to new outbreaks of diseases such addressed in continuous professional devel- as measles. More than 100 measles-related opment. New skills are needed to address CPME has a long-standing commitment vaccine hesitancy and discuss vaccine-related to affirming that the prevention of commu- deaths and over 100,000 measles cases have concerns with patients. Particularly good nicable diseases through vaccination is safe occurred since 2016 in the WHO European communication skills are needed to improve and effective. Immunisation through vacci- Region. This has caused new concern for trust between doctors and patients. Vaccine nation is the best protection against serious decision-makers, public health experts and hesitancy is not a new phenomenon, but infectious diseases but also one of the most healthcare professionals. nowadays it spreads fast on the internet. The successful and cost-effective public health small but vocal group of anti-vaxxers can interventions. Coverage rates and the role of influence normal people through different healthcare professionals social media platforms. Doctors and other Due to insufficient vaccination coverage healthcare professionals should be equipped rates, the EU and its member states need to explain the difference between misinfor- to strengthen their cooperation to ensure mation and the facts. equitable access to vaccines for all EU citizens. They have to fight disinformation and improve Raising awareness of parents should vaccine confidence. The Council of the EU has be started already during prenatal care. Healthcare professionals should also adopted a recommendation to strengthen acknowledge that there is a small possibility the EU cooperation on vaccine-preventable of risks related to some vaccines for some diseases. The European Commission has individuals. Moreover, the collective interest launched a joint action on vaccination and the of vaccination should be highlighted. Herd European Parliament has adopted a resolution immunity works only when almost all people expressing concerns about Europe‘s insuf- in the population are immunised. At EU level ficient coverage rates and its impact on public this means that one country‘s immunisation health. However, vaccination policy as such weakness puts the health and security of remains a competence of national authorities. other countries at risk. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 3 3 Vaccination in Pharmacies

vaccinate, public awareness increases and vac- Pharmacies must as well have an adequate cination rates increase.1 In addition, statistics room for providing the vaccination with all show that provision via Irish community phar- necessary equipment, and be able to manage macies increases coverage for people who had any anaphylactic event (for example, use never received the vaccination before (one of adrenaline to be administered by the in six), with 99% of patients indicating that pharmacist).4 they would return to the pharmacy for their In many of the other European countries, next vaccination. Patient satisfaction with the there exist also additional opportunities to service is very positive with 93% of patients closer engage community pharmacists in the rating the service either 9/10 or 10/10.2 fight against lowering vaccination rates and Outside Ireland, many other established increasing vaccination hesitancy. With their examples can be found across Europe where rigorous scientific educational background and pharmacists are having a hands-on role in an established position as a pillar of the local Michał BYLINIAK administering vaccines, such as in Denmark, community, (often with life-long relationships Portugal, Switzerland and the United with their patients and communities), com- President of PGEU (The Pharmaceutical Kingdom. In addition to administering flu vac- munity pharmacists are an excellent resource Group of the European Union) cinations, community pharmacists administer for providing evidence-based, unbiased and other vaccinations (for example, pneumo- balanced information on the benefits and risks coccal, shingles, human papilloma virus (HPV), of vaccination. It is crucial that information travel vaccinations) in five European countries. provision to the public on vaccination is done France has been the most recent country as part of an integrated, consistent and mul- n the light of the declining vaccination in Europe (March 2019) that has allowed tidisciplinary approach across the different coverage rates across Europe, European pharmacists to administer flu vaccinations in healthcare setting so that wherever people societies depend now more than ever on the pharmacy following a very successful pilot access the healthcare system, they receive I 3 a strong and unified healthcare workforce to project. All community pharmacists in the qualitative information on immunization and help combatting the issues of low vaccination French territory are now eligible to administer that they can be identified as a potential risk/ confidence and trust, misinformation and the flu vaccines in the pharmacy, subject to target group for vaccination. Shared electronic remaining barriers to convenient access. the conditions that they have followed the vaccination/health records could improve Community pharmacists have always required training programme and that the the efficiency of such communication in the advised patients on the importance and/or pharmacy has the appropriate premises and future. appropriateness of immunisation, identified equipment to ensure a private and qualitative To summarise, European community phar- and reminded target groups for vaccination, service provision. macists can improve access and convenience and of course dispensed and advised on Similar requirements for training and appro- to vaccination information and delivery vaccines. Most pharmacists in Europe would priate premises/equipment are in place in all to citizens as a complementary service to regard that as part of their core activity. But other European countries where pharmacists established vaccination services. To increase we are now seeing in recent years this going are allowed to administer vaccines. In Portugal vaccine coverage and help tackling vaccine a stage further with pharmacists carrying for example: hesitancy it is crucial to make better use of out immunisation themselves within the 1. Pharmacists must complete mandatory pharmacist-delivered vaccination services as pharmacy, as a complementary service to training on vaccination; an integral part of national vaccination pro- existing vaccination services. 2. Recertification must take place regularly grammes. Pharmacists across Europe are ready More than two-thirds of Europeans can (every five years in Portugal); to work closely work together with their fellow access a pharmacy within five minutes, fol- 3. Pharmacists must provide evidence of healthcare professional colleagues and the lowing which they can consult a community continued activity; authorities to ensure that the implementation pharmacist without any appointment. For 4. Pharmacists must obtain a certification of vaccination policies in practice can reach instance for flu vaccination, this offers a tre- on Basic Life Support. their full potential and can ensure a maximum mendous opportunity to reach parts of the increase in both coverage rates and public public that have not received a flu vaccination trust in vaccination across Europe. before. 1 http://ipu.ie/wp-content/uploads/2019/08/ Numbers from Ireland have shown that since IPU-Review-AUG2019-WEB.pdf pharmacists first started vaccinating in 2011, 2 https://www.thepsi.ie/Libraries/Pharmacy_ flu vaccine deliveries through the National Practice/Report_on_Patient_Feedback_on_the_Flu_ Immunisation Office (NIO) have increased Vaccination_Service_Provided_in_Pharmacies.sflb. overall by 48% and, within that, deliveries ashx 4 https://www.pgeu.eu/wp-content/ to general practitioners are up by almost 3 http://www.ordre.pharmacien.fr/Les-pharmaciens/ uploads/2019/07/180403E-PGEU-Best-Practice-Paper- 23%, demonstrating that when pharmacists Champs-d-activites/Vaccination-a-l-officine on-Communicable-Diseases-and-Vaccination.pdf 3 4 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Independent control contributes to ensuring vaccine quality

of each licensed batch of vaccine conforms to provide the best quality products. OCABR also the approved specifications, independently allows the authorities to have an overview of from the release tests performed by the manu- the products that will be available, or not, on facturer and before the batch reaches the the market and thus potentially help them to patient. anticipate possible shortages.

OCABR is therefore an additional guarantee In 2018, through efficient work sharing, of the quality of these important products. It OMCLs from 12 different member states tested includes a review of the manufacturer’s batch over 4000 final lots of vaccines to the benefit of documentation and testing of a pre-defined patients in all member states. OMCLs are con- set of critical quality parameters that have stantly evolving to face new challenges, such as been agreed by the network experts. To avoid vaccines with an ever-higher number of com- impacting the timing for availability on the ponents and complex and sophisticated new Susanne KEITEL market the procedure is generally done in testing methods, as well as the logistical chal- parallel to the manufacturer’s own production lenges linked to manufacturers’ increasingly Director of the EDQM, Council of Europe and release procedures. global production strategies.

Article 114 specifies that OCABR results from According to the World Health Organization one member state must be recognised in all the an estimated 2-3 million lives are saved ever others, thus avoiding the duplication of work, year thanks to vaccines. Despite the accu- conserving vaccine samples for use in patients mulated evidence of the benefit of vaccines, ince 1994, the EU Official Control and reducing the burden on manufacturers. vaccination coverage in the EEA is sub-optimal. Authority Batch Release (OCABR) Compliant batches, which have been evaluated In April 2018 the European Commission com- S network has played a key role in ensuring by an OMCL according to codified procedures municated (COM(2018) 245/2) a strategy to vaccine quality. This network of state labora- and under an externally audited quality system, address this issue, highlighting vaccine hes- tories, Official Medicines Control Laboratories receive an EU OCABR certificate which is then itancy as one of a complex set of contributing (OMCLs), is part of the General European recognised throughout the EEA to allow release factors, amongst other issues including vaccine OMCL network, which is supported by the EU to market. These certificates are also recognised supply management. The Council recommen- Commission and the Council of Europe (CoE) outside the EEA as a sign of quality. If a batch is dation of 7 December 2018 on strengthened and co-ordinated by the European Directorate not compliant, all member states are informed cooperation against vaccine-preventable for the Quality of Medicines and HealthCare to ensure that the batch is not placed on the diseases (2018/C 466/01) sets out a number of of the CoE. OCABR, which is also applied to market. important recommendations. Support for the human blood-derived medicinal products, is EU OMCL Network to ensure that vaccines an integrated part of the medicines regulatory Since OCABR is carried out in real time on placed on the market are of high quality is system in the European Economic Area (EEA) every batch, the OMCLs can monitor trends among them. as foreseen by the codified EU Directive for in results and take preventive action if needed. Human Medicines, 2001/83/EC, as amended. Thanks to this surveillance, OMCLs regularly The quality of vaccines is important both for The Directive includes provisions for marketing identify issues which, with the input of the the individual patient and for public confidence authorisation, obligations to comply with good regulatory authorities and manufacturers to foster adherence to vaccination programs. manufacturing practice and oversight through involved, can be corrected so only the batches OCABR is an independent control system that inspection, pharmacovigilance and market sur- with conformant quality reach the patient. helps to ensure that no matter where a patient veillance by the authorities. is in the EEA, they benefit from the same high One strength of the OCABR network is com- standards. OCABR certificates facilitate the Specifications for the quality of medicines, munication. The information gained during the movement of vaccines within Europe, which including vaccines, are defined in their mar- OCABR process is available to the responsible is beneficial for vaccine supply management. keting authorisation dossiers, which are authorities in all member states and can be used The contribution that OMCLs and the OCABR assessed by experts at the European Medicines to help ensure the continued high quality of system make to ensuring good quality vaccines Agency or national competent authorities as these medicines. Maintenance of experimental merits support. Like vaccination, OCABR is part of the licensing procedure. They should testing at OMCLs secures expertise inde- a preventive measure that is good for public comply with the monographs of the European pendent from the manufacturers. Since OMCLs health. Pharmacopoeia, which sets the legally binding have hands-on experience with vaccines from quality standards for medicines in its member different manufacturers, they have a unique states, including the EEA. OCABR (article 114 of insight and contribute to the establishment the Directive) allows a member state to verify of common methods and standards which through testing at an OMCL that the quality helps both authorities and manufacturers to E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 3 5 Healthcare distribution: facilitating optimal access and uptake of vaccines in Europe

and effectiveness can be altered easily by the time spent by an individual pharmacy on influence of environmental factors such as ordering, receiving and processing invoices overheating or freezing and they naturally from the various manufacturers whose biodegrade over time. This may result in the vaccines it buys from. With this, healthcare failure of the vaccine to create the desired distributors add value to the sustainability of immune response and consequently provide healthcare systems across Europe and con- poor protection. An essential part for many tribute to a secure and stable system of supply. of the vaccines supplied across Europe thus is the maintenance of the so-called cold-chain, Supporting confidence in vaccines which is refrigerated transportation, between Despite the obvious positive contribution the manufacturer and the end-user. vaccines have made to European healthcare systems and the overall public health in the Adding value to vaccines supply last decades, vaccine confidence has slowly Monika DERECQUE-POIS Healthcare distributors are essential been decreasing in popular opinion and dis- partners when it comes to the safe and information on vaccination continued to rise Director General of GIRP efficient distribution of vaccines. Because the across Europe. supply process must be robust, reliable and Thus, it has become even more important routinely monitored for possible deviations at for healthcare distributors to ensure end- accination is a story of success in the all points of the value chain, with their state- users can trust that their supply chains work field of medical science. Since the first of-the-art distribution systems, healthcare dis- impeccably and robustly. Healthcare dis- V vaccine was administered over 200 tributors play a crucial part in the vaccination tributors have been stepping up to assure to years ago, vaccination has helped to reduce or process. their customers and patients that their con- even eradicate widespread infectious diseases Equipped with the latest refrigeration tech- tinuously and professionally monitored cold- across the globe. Vaccines nowadays prevent nologies for both storage and transportation of chains are up to the challenge to keep vaccines millions of deaths worldwide each year and vaccines, temperature monitoring equipment safe and secure. significantly reduce costs for healthcare and meticulously planned, mapped, and risk- systems dealing with uninoculated diseases. assessed transport routes according to current GIRP, the European Healthcare Distribution Making vaccines available on a large scale European regulations they support industry in Association, is the umbrella organisation for requires complex production methods, getting their medicine to the right place at the pharmaceutical full-line wholesalers and dis- meticulous quality control and reliable distri- right time while guaranteeing all products are tributors of healthcare products and services in bution channels that ensure the products are kept safe and effective. Europe. It represents over 750 pharmaceutical potent and effective when patients receive By assuming a quantity-based buffer wholesalers serving 34 European countries. them. Guaranteeing availability and effective function for healthcare providers, which GIRP members employ over 140,000 people and delivery of the product also requires strong means stocking vaccines under the right distribute around 15 billion packs of medicines partnerships between manufacturers and their conditions and in sufficient quantities for as well as a wide range of healthcare products supply chain partners. This is where healthcare their geographical area of activity, healthcare per year. As the vital link in healthcare, they distributors make a crucial contribution distributors can bridge bottlenecks in peak are committed to developing and providing to facilitating optimal access to vaccines in demand times and are in a unique position innovative and efficient healthcare products Europe. in the supply chain to pre-finance bulks of and services to improve health and wellbeing of essential vaccination supplies that ultimately patients across Europe. Vaccine distribution: a delicate enable pharmacists and matter physicians to focus fully The European Union puts great emphasis on the patient and to Vaccine distribution in Europe on supporting and strengthening the role of provide superior clinical vaccines in European healthcare systems as care. one of the most cost-effective and efficient Healthcare distributors public health measures available to prevent also assume vital and serious diseases. The EU also applies strict rules important bundling for the approval of vaccinations to be allowed functions of vaccines that on the European market and follows up with draw together supplies post-authorisation surveillance of vaccinations from several different to ensure maximum safety for patients. manufacturers into This is especially important, as vaccines are one delivery pool. This delicate and sensitive medical products. They function is of high value to vary in stability, which means their potency pharmacies as it reduces 3 6 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e AIM calls for European Action with regard to Vaccination Hesitancy

different groups of people and risks into con- Member States have the com- sideration. Moreover, it is important that the petence with regard to compulsion reimbursement of those vaccines does not In that context, compulsion seems to be fall solely on health insurance institutions but the perfect quick-fix to increase coverage is also borne by the State as vaccination is a rates and achieve herd immunity. Yet, com- public health responsibility. pulsion is against the values of freedom and democracy on which the European Union Vaccination should be allowed was built. Furthermore, Member States have outside clinical settings under the competence regarding the decision on certain conditions compulsion and should keep it. In the case of By allowing vaccination outside clinical “non-compulsion”, it is of utmost importance settings, the most vulnerable in society could that citizens are empowered by tailored and be reached and as a consequence, health ineq- comprehensive information describing the Christian ZAHN uities could be tackled. Pharmacists, nurses risk-benefits balance. They should be able to or public health workers (e.g. carers) may be, make well-informed decisions and to avoid President of AIM (International Association depending on national legislation, entitled to unreasonable fear of side effects. One solution of Mutual Benefit Societies) vaccinate as well. However, before allowing to ensure to reach a higher coverage could be such practices, their added value must first of to envisage a policy option such as opting-out all be investigated. Furthermore, if vaccines are of vaccination. An opt-out would be subject to be made available outside clinical settings, to a formal process through which awareness the administrator must be properly trained about risks of not being covered is built. Vaccination is one of the most successful to communicate with the patient in order to and cost-effective interventions to improve provide him with comprehensive information An EU passport for vaccination is health outcomes of people. High uptake rates without inducing fear, and to respect safety needed have allowed to eliminate, and in some cases measures. Citizens need clear, non-biased and trustful eradicate, a number of diseases. And yet, the information on vaccines and clarity about last decade has been characterized by out- Safety of vaccination should be vaccination schedules. An EU-wide schedule, breaks of measles, mumps, or polio in some always guaranteed providing minimum standards, and an EU countries where those diseases had previously Vaccines are administered to people who are vaccination passport would allow to reduce been controlled or extinct. Vaccination and usually healthy and in most cases to children. confusion around diverging schedules and lack vaccine safety have consequently become a Therefore, a higher degree of safety is often of consistency between and within Member priority at European and Global level. A debate expected for vaccines than for other pharma- States. It would also be an added value in has been launched on whether and how vac- ceuticals or other healthcare interventions. To the case of cross-border care, cross-border cination could be organised at EU level. At the ensure the safety of vaccines, we believe it is movement, joint procurement of vaccines same time an EU-wide campaign has started important to improve spontaneous reporting and to generate much needed statistics at EU to fight against vaccine hesitancy. At AIM, we of adverse event(s) following immunization level. Of course, such a proposal raises many are convinced of the added value of European (AEIF) and pooling of AEIF data globally in challenges, notably regarding the electronic action in this field. More than reimbursing order to reduce time to identify rare vaccine vaccination registers and their interoperability. healthcare costs as payer organisations, our reactions. AIM sees a clear need for standard Healthcare institutions and all healthcare members have a mission of general interest methodologies for active surveillance and a professionals involved in vaccination must and have the responsibility of striving for standard reporting format for AEIF should be have the capacity to electronically register the better public health, an aim for which vacci- developed. This would help ensure a proper vaccination status and information of citizens, nation is a sine-qua-non condition. monitoring of vaccines after their use. AIM without being subject to a duplication of welcomes the work done under the EU Phar- work at national level. Those challenges and Accessibility to vaccines is key for macovigilance system. If this collaboration the others previously described (also men- high coverage rates between European Commission, Member tioned in our position paper) can only be One of the key aspects of accessibility is States and the European Medicines Agency tackled through EU collaboration and with of financial nature and thus linked to reim- is of utmost importance, the proper dissemi- the involvement of all actors, governments, bursement. AIM is convinced that vaccines nation of its outcomes to the general public doctors, hospitals, pharmacists, parents, included in vaccination schedules should be is equally crucial. AIM would call for making patients, and, of course, healthcare payers. fully reimbursed so as to remove any potential the information on vaccination resulting from financial obstacle. To guarantee patient safety the EU Pharmacovigilance system more visible but also safeguard citizens’ trust, it is key for and accessible to the general public. Indeed, those schedules to be established on the perceived safety is a key challenge and vaccine basis of scientific recommendations taking hesitancy a growing issue across the EU. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 3 7 Vaccines - The educational and preventive role

and have the best chances of surviving than the task are provided with the best resources. ever before in human history. Eighty percent Otherwise, we will fail. of children worldwide are vaccinated for at least one disease. We must not forget that not everyone can However, history took an unthinkable twist. have the luxury to be vaccinated; there are Somehow, in countries were vaccines are easily people that live in remote areas of the globe accessible, adults stopped vaccinating their that do not have access to the recommended children. vaccination programs; there are persons all around the globe that, even though they are It is important to understand that in vaccinated, their cellular army is not properly medicine, as in any decision in life, there are function; they are immune suppressed and of risks. However, risks are to be balanced with high risk of being infected. In high risk of perish well-informed access to scientific evidence. from a preventable disease. It is a community Sara CERDAS If today, most of the world recognizes the effort, and one where everyone plays a role, harmful effects of climate change, that cannot spreading the most accurate and evidence- MEP (S&D Group), be said for the benefits of vaccines. Despite based information. Member of the ENVI Committee consensus in the medical and scientific com- In an era where antimicrobial resistance is munity, Europe is facing an ever increase earning an emergency status, where climate number of outbreaks, for diseases that we change is making access to safe water harder, can be protected for; they are called vaccine in an era were vaccines are safer than ever and preventable diseases. And it is only with con- work, action is needed. Today. orldwide, people are living longer. certed action by the different players, that In fact, in the last 100 years, human this untruthful and fake-inspired wave of the W life expectancy increased by 30 anti-vaccination movement can be overcome. years. It is not through strength; it is not through There are a multitude of factors that mandatory laws. Public Health professionals account for this increase in human’s life must be called into action and step up for this expectancy, but one cannot deny the role emergency; and must be equipped with the public health measures had. Access to best tools we have at our disposal: evidence- safe drinking water and water waste man- based information. agement, the discovery of antibiotics and And policy makers must clear up the way vaccines. and guarantee that all actors commissioned to

Human beings stopped being exposed to microorganisms that otherwise would be fatal to them through life’s most ingested substance, water. If a person did indeed, through any transmission mode was infected, bacteria could be fought hand in hand with antibiotics, medicines that actively target the harmful microorganisms that would otherwise translate in high death rates by most commu- nicable diseases. And vaccines, the scientific breakthrough wonder substances, if you had the chance to be vaccinated your immune system will be in contact with a short (or a dead) part of the pathogenic microorganism and consequently, if you got in contact with the real pathogenic microorganism, your own cellular army called immune system would fight them off in a stronger and efficient way. The combination of these three public health measures did indeed contributed for a massive transformation in human life. We live longer, and healthier. Our children are born 3 8 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e The EU research programmes in support to vaccine Research & Innovation

Irene NORSTEDT Alessandra MARTINI Julia MOLTO LOPEZ Barbara KERSTIËNS Acting Director, People Policy officer, Directorate-General Programme assistant EU policies, Head of Unit Combatting Directorate, Directorate-General for Research and Innovation, Directorate-General for Research diseases, Directorate-General for Research and Innovation, European Commission and Innovation, European for Research and Innovation, European Commission Commission European Commission

Vaccines: their power, their What is the EU doing in the area What the EC does to overcome challenges of vaccination challenges in vaccine research and innovation accination is among the most The EU is actively involved in the global impactful and cost-effective medical efforts to overcome these challenges. The A number of scientific challenges to V interventions ever introduced for political commitment in support of vacci- developing new and better vaccines remain, prevention of infectious diseases. Each year nation is laid down in the Commission Com- as well a need to understand and address vaccines prevent 2-3 million deaths from munication and Council recommendation the determinants for the decrease in vaccine diseases like diphtheria, tetanus, pertussis on strengthened cooperation against vaccine- uptake. The Commission is strongly committed and measles1, as well as prevent infection- preventable diseases3 adopted in December to providing solutions to these challenges, as related cancers and protect the health of 2018, aiming to increase vaccination coverage, well as to strengthening the involvement of all the vulnerable. Promising research on thera- foster support to research and innovation, relevant stakeholders in the research process peutic vaccines also opens new horizons for and strengthen EU cooperation on vaccine- (e.g. patient community, social scientists) and the treatment of diseases. Nonetheless, preventable diseases. Among the many actions supporting the generation of high quality data several countries are having a comeback of proposed is the establishment of a European for evidence-based recommendations. vaccine-preventable diseases2, with mistrust Information Sharing System; the creation of in vaccines playing a key role in this phe- a European vaccination information portal Through the current framework programme nomenon. Additionally, for a number of major by 2019; and an increase in the effectiveness for research and innovation, Horizon 2020 infectious diseases suboptimal or no vaccines and efficiency of EU and national funding for (H2020), so far over €620 million have been exist. Currently, the many challenges faced in vaccine R&D4. invested on vaccine R&I5. A significant amount vaccine research and development make the of this EU investment went to large con- development of vaccines lengthy, complex sortia performing translational collaborative and with a high risk of failure. research spanning work from discovery to first-in human studies, with projects gen- erating results such as predictive tools as well as promising vaccine candidates against HIV, TB and malaria. Horizon 2020 has also provided funding for the development of 1 WHO Immunization coverage. http://www.who. int/mediacentre/factsheets/fs378/en/ 3 https://eur-lex.europa.eu/legal-content/EN/TXT/ 2 https://ecdc.europa.eu/en/about- PDF/?uri=CELEX:32018H1228(01)&from=GA uswho-we-aredisease-programmes/ 4 https://ec.europa.eu/health/sites/health/files/ vaccine-preventable-diseases-programme vaccination/docs/2019-2022_roadmap_en.pdf 5 https://cordis.europa.eu/projects/en E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 3 9

vaccines against several neglected-infectious more effective types of cooperation, covering Preparedness Innovations11 (CEPI), an inno- diseases and influenza, as well as Ebola. different needs in vaccine R&I, and creating vative global alliance supported by H2020, was The H2020 portfolio also includes projects incentives for industry investment in vaccine established in 2016 with the aim to finance tasked to evaluate vaccine effectiveness. The development. and coordinate the development of new I-MOVE+6 project developed a platform To accelerate the development of medical vaccines to prevent and contain infectious to measure and compare the effectiveness products, including vaccines, for poverty- disease epidemics. and impact of influenza and pneumococcal associated and neglected infectious diseases, Due to the high failure rate during the vaccines, as well as vaccination strategies in the in 2003 the European and Developing product development stages, investment in elderly. The generated data provided useful Countries Clinical Trials Partnership9 vaccine R&I is risky, therefore giving financial insights to public health authorities on these (EDCTP) was launched. A partnership between incentives an important role to play in over- vaccines and on how to use them effectively. African and European countries and the EU, it coming this challenge. In 2015 the Com- The Commission is also supporting the second is currently in its second phase (2014-2024), mission launched the InnovFin Infectious phase of TRANSVAC, a collaborative infra- with a budget of €1.3bn. Diseases Financial Facility (IDFF)12, jointly structure project which supports innovation The Innovative Medicine Initiative10 (IMI), with the European Investment Bank (EIB), to for both prophylactic and therapeutic vaccine a partnership between the EU and European facilitate and accelerate access to finance for development and functions as leverage and Federation of Pharmaceutical Industry and innovative businesses and other innovative innovation catalyst between vaccine R&D Association (EFPIA), was created to speed-up entities in Europe. stakeholders. the development of, and patient access to, The Commission has also supported innovative medicines. Now in its second phase A glance on the future research to understand behaviours towards and with a budget of €3.27bn, IMI is substan- Horizon Europe, the new EU research vaccination. The TELL ME7 collaborative tially supporting vaccine research. Through and innovation programme, is now under project provided evidence and developed IMI’s Ebola+ programme, with a budget of over preparation. Its three pillars (Excellent Science; models for improved risk communication and €200 million, Ebola vaccine candidates have Global Challenges and European Industrial strategies addressing vaccine-hesitant groups, been funded, as well as tools to facilitate the Competitiveness; Innovative Europe) and among others. The E-com@EU8 project deployment and acceptance of such vaccines, activities targeted to widen participation developed communication plans for Under- which are now being used in the Democratic and strengthen the European Research Area, Vaccinated Groups (UVGs), a tool useful Republic of Congo (DRC) and neighbouring will build on the efforts and successes of the for health professionals, health agencies and countries in the global effort to contain the previous programme. Horizon Europe will Institutes of Public Health (IPH) in periods of current epidemic. provide new models and opportunities to outbreaks. The 2014 Ebola outbreak evidenced that boost and improve vaccine development and In addition to the direct investment the current market processes did not aid will be instrumental in further stimulating through H2020, a number of partnerships the development of products for diseases cross-fertilisation and international collabo- and initiatives have been created to enable for with epidemic potential. To help tackle rations to bring public health benefits to the this challenge, the Coalition for Epidemic citizens.

6 http://www.i-moveplus.eu/ 7 https://www.tellmeproject.eu/content/ 11 https://cepi.net/ project-summary 9 http://www.edctp.org/ 12 https://www.eib.org/en/products/blending/ 8 http://ecomeu.info/ 10 https://www.imi.europa.eu/ innovfin/index.htm 4 0 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Vaccination in Europe – the crucial role of the health care provider

despite the availability of vaccination services’ Overall this illustrates that HCPs can play – as one of the top ten health threats to the a crucial role in addressing vaccine hesitancy world in 2019. and in communicating with vaccinees or Therefore recognizing and identifying their parents. Paterson et al (2016) reviewed champions who can inform, communicate a number of studies from which it is clear and encourage confidence in immunization that a good knowledge is related to a better is key. Partnering with future and current confidence and improved recommendations. HCPs is a good opportunity to promote the Evidence suggests that improved knowledge importance of vaccination. through training also improves vaccine con- Health care providers in Europe fidence in HCPs. In addition, HCPs who are vaccinated themselves are more likely to rec- HCPs are among the most trusted sources of ommend vaccines to others; they also lead by immunisation information, and therefore are a example or role model (Maltezou et al, 2019). Pierre VAN DAMME core group to address low or declining public In agreement with these findings Paterson et confidence in vaccination. However, reliance al (2016) report that a lack of preparedness for MD, PhD, vice-dean faculty of Medicine on HCP to provide optimal guidance to target advising patients about vaccination and a lack and Health Sciences, director Centre for the population may be jeopardised if HCP, them- of training act as inhibiting factors for recom- Evaluation of Vaccination, University of selves, have doubts about vaccines or if they mending the vaccine. Antwerp, Belgium. do not communicate effectively with their Unfortunately a lot of work remains to be clientele. A qualitative study among HCP from done in Europe to well educate and train our four different European countries (Croatia, future HCP, nurse, pharmacist and midwife. In Introduction France, Greece and Romania (Karafillakis et order to estimate the current basic knowledge al, 2016) showed that, in general, while the of EU medical students towards vaccines and mmunization has been a great health benefits of vaccination were appreciated there vaccination policy in Europe, a large web-based success story. Consistent widespread use were also risks considered to be important survey was performed among the students of I of vaccines has proven successful in con- such as the fear of side-effects, especially for the European Medical Student Association trolling or even eliminating disease. Indeed, new vaccines, and the HCP’s responsibility for (2018): overall, 73% indicated to have courses diseases that commonly killed infants, these side-effects if they should occur in their in vaccinology in their curriculum, ranging children, adolescents and adults only decades patients. While some HCP see it as their role from 1-2hours up to several courses. Up to ago are now virtually unknown in many to respond to hesitancy and have impact one 20% of last year medical students never had countries. However, many young people and their patients’ decision, others feel they should had vaccinology teaching in their curriculum! even health care providers (HCPs) are not remain neutral, and leave it to the patients aware of these diseases that have been elim- to decide. In general, it was felt that vaccine To assist HCPs in obtaining up-to-date inated and others may not fully comprehend confidence could be improved by more knowledge and information on vaccines and the value of vaccines and the importance of information (e.g. on side-effects) and training vaccination programmes, increasingly post- herd immunity. Moreover, no matter how (e.g. communication skills), as well as stricter graduate courses and in-service trainings are strong the science may be and how large legislation. being organized at a national, regional and and uniform the expert consensus, young Larson et al (2018) showed in a large-scale international level. In an attempt to list all adults and adolescents are far more likely to survey that there is a positive correlation available courses on vaccinology worldwide, a be influenced by the opinions and actions of between the GPs believes about vaccines global vaccinology e-portal was set up recently a friend or peer, or a message on twitter or and the public confidence. This recent study (https://www.global-vaccinology-training. facebook, particularly in the digital age. Over assessed the overall state of confidence in com/) (Duclos et al, 2019). the past decade, an increasing number of vaccines among the public in all 28 EU member studies have documented a rising amount of states and among general practitioners (GP) Conclusion people in both high–income and low-income in ten EU member states. The survey found HCPs serve as the most trusted advisors and countries who are losing confidence in that overall GPs are confident in the safety, influencers of vaccination decisions. A lack vaccines, to the point of choosing not to vac- importance and effectiveness of vaccination of knowledge among HCPs is considered one cinate their children (https://wellcome.ac.uk/ and have higher levels of confidence than the of the most important factors for vaccine reports/wellcome-global-monitor/2018/). general population (except for 1 country). hesitancy. Major efforts are needed to prepare According to organizations such as the WHO While these results are re-assuring and confirm and assist our EU HCP through pre- and and UNICEF, gains in the world’s fight against results from other studies that only a minority in-service training. vaccine-preventable diseases are at risk. of health care providers have concerns about The WHO has specifically identified vaccine vaccines (Karafillakis et al, 2016; Paterson et al, hesitancy – which the organization defines as 2016), confidence of GPs in MMR vaccination ‘the delay in acceptance or refusal of vaccines is lower in certain countries in the survey. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 4 1

Literature:

Duclos P, Martinez L, MacDonald N, Asturias E, Nohynek H, Lambert PH; all participants of the Global Vac- cinology Training Workshop. Global vaccinology training: Report from an ADVAC workshop. Vaccine. 2019 May 16;37(22):2871-2881

Karafillakis E, Dinca I, Apfel F, Cecconi S, Wurz A, Takacs J, et al. Vaccine hesitancy among healthcare workers in Europe: A qualitative study. Vaccine. 2016;34:5013-20.

Larson H, de Figueiredo A, Karafillakis E, Rawal M. State of Vaccine Confidence in the EU 2018 – Report 77p. ISBN 978-92- 79-96560-9 doi:10.2875/241099 – Publli- cation office of the European Union, 2018.

Maltezou HC, Poland GA. Vaccination policies for healthcare workers in Europe. Vaccine. 2014;32:4876-80.

Maltezou HC, Botelho-Nevers E, Brantsæter AB, Carlsson RM, Heininger U, Hübschen JM, Josefsdottir KS, Kassianos G, Kyncl J, Ledda C, Medić S, Nitsch-Osuch A, de Lejarazu RO, Theodoridou M, Van Damme P, van Essen GA, Wicker S, Wiedermann U, Poland GA; Vaccination Policies for HCP in Europe Study Group. Vaccination of healthcare personnel in Europe: Update to current policies. Vaccine. 2019 Oct 14. pii: S0264-410X(19)31285-X

Paterson P, Meurice F, Stanberry LR, Glismann S, Rosenthal SL, Larson HJ. Vaccine hesitancy and healthcare providers. Vaccine. 2016 Dec 20;34(52):6700-6706 4 2 | T h e E u r o p e a n F i l e s | E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e Maternal vaccination: A new and highly effective policy to improve European pertussis immunisation programmes

the vaccination has dramatically decreased in The second strategy the direct protection of some developed countries leading to a lower new-borns and infants thanks to maternal immu- rate a vaccine coverage rate and the resurgence nization. As natural infection does, it has been of pertussis. known for a long time that vaccination during pregnancy, referred to as maternal immunization, The second generation of pertussis can provide protection for the new-born through vaccines maternal antibodies actively transferred via the Acellular pertussis vaccines were developed in placenta. response to those issues. They contain purified In response to the national outbreak in 2012, components of B. pertussis such as inactivated with 14 deaths among 429 infant cases infected pertussis toxin either alone or in combination with pertussis, the United Kingdom, was the with other B. pertussis components. If the first country in Europe to initiate a maternal relative protective efficacy of the best wP and aP vaccination programme. Pregnant women were Benoit SOUBEYRAND MD vaccines are comparable, safety studies of the aP offered a single dose of aP vaccine between 28- have invariably found the acellular vaccines to and 38-weeks’ gestation. Of note, despite the Blossom Vaccinology, Lyon, France be better tolerated than the wP vaccines. Con- theoretical basis, the effectiveness of this new sequently, since 1996, aP vaccines have gradually immunization policy in the prevention of infant idden potential of full benefit of vaccines supplanted the use of wP vaccines in industri- disease had not been established prior the imple- lies in immunization policies. This is high- alized countries for children immunization. mentation. In addition, according to regulatory H lighted by maternal immunization against information, the vaccine chosen to run the pro- pertussis. Originally developed for improving Although routine pertussis vaccination gramme was not recommended during pregnancy, the acceptability of pertussis immunization in of infants and young children reduced the due to limited post-marketing information on the children, the new generation of pertussis vaccines, incidence by more than 99%, the disease persists safety. Studies carried out for assessing the new so called acellular pertussis vaccines (aP), are now today. In addition, there has been a shift in the policy found that maternal vaccine effectiveness used in pregnant women for eliminating the age-specific disease profile with an increased was 90–93% against pertussis and 95% against residual cases of pertussis infant mortality. proportion of cases among infants below 1 year infant death. Large safety studies didn’t show sig- of age too young to be vaccinated and among nificant increased risk of recognized maternal con- The pre area individuals above 15 years of age. This shift ditions or of adverse events in infants born from Before vaccines became widely available in the has been attributed to the waning of vaccine- vaccinated women. Since then, Belgium, Czech 1950s, pertussis was one of the most common induced immunity, because wP vaccines can’t be Republic, Greece, Ireland, Italy, Portugal and Spain childhood diseases worldwide. 80% of cases used for booster immunization in individuals > 7 have introduced similar maternal vaccination pro- occurred in children < 5 years and less than 3% in years of age due to local reactions which increase grammes [ECDC] joining several non-European persons aged ≥15 years. Pertussis was and is still a with age and the number of injections. countries (e.g. Argentina, Israel, New Zealand, UK, severe disease particularly in infants with a case USA). fatality rates estimated to be 0,20%, in low-mor- Additional strategies for preventing Considering that vaccination of pregnant tality countries explaining that the first objectives early infant mortality women is likely to be the most cost-effective addi- of pertussis vaccination is the prevention of The availability of aP vaccines, better tol- tional strategy for preventing disease in infants severe disease and deaths among infants below erated, provided the opportunity to consider too young to be vaccinated, World Health Organi- 12 months of age. booster doses in adolescents and adults for pre- zation encourages countries to consider vacci- venting early mortality in infants too young to nation of pregnant women. And recently, despite The first pertussis vaccines be vaccinated. moderate to severe local reactions associated with The first vaccines developed against pertussis combined tetanus and diphtheria antitoxin (Tdap were the whole-cell pertussis vaccines (wP), which The first strategy is the indirect protection of vaccine) and the lack of monovalent aP vaccine are suspensions of killed B. pertussis organisms. infants by reducing the risk of infection through (i.e. standalone), the USA has recommended that The vaccines were introduced for children widely booster on regular basis in adolescents and pregnant women receive Tdap boosters during in industrialized countries in mid-20th century adults or targeted on the close contacts of infants each pregnancy considering the potential benefits and included in the Expended Programme of (i.e. “cocooning” strategy). However, widening of maternal pertussis immunization. Immunization since 1974. coverage with pertussis vaccines appears to have Whole-cell pertussis vaccination have been had limited impact in preventing transmission In summary, the success of the implemen- highly successful. It was estimated that without or on the resurgence of periodic epidemic peaks tation of maternal pertussis vaccination in several vaccination there would have been >1.3 million in some countries. In 2017, 42 242 cases of per- European countries with a vaccine originally pertussis related deaths globally in 2001. In tussis were reported in EU/EEA countries. Indi- developed for infant immunization and with the 1980’s due the dramatic reduction of the viduals ≥ 15 years of age accounted for 62% of limited data of its use in pregnant women highlight number of cases of pertussis and rising safety all cases reported and infants < 1 year were the the importance of immunization policies and their concerns regarding the vaccine, acceptability of most affected age group. active follow-up to fully benefit from new vaccines. E u r o p e & V a c c i n e s - F o r effe c t i ve v a c c i n a t i o n p o l i c i e s i n E u r o p e | T h e E u r o p e a n F i l e s | 4 3

Selected bibliography • ECDC. Pertussis - Annual Epidemio- logical Report for 2017 [Internet]. Available from: https://www.ecdc.europa.eu/sites/ default/files/documents/AER_for_2017- pertussis.pdf • Edwards KM, Decker MD. 44 - Per- tussis Vaccines. In: Plotkin’s Vaccines (Seventh Edition) [Internet]. Elsevier; 2018 [cited 2018 Mar 19]. p. 711-761. e16. Available from: https://www.sci- encedirect.com/science/article/pii/ B9780323357616000432 • World Health Organization. Per- tussis vaccines: WHO position paper – August 2015 [Internet]. 2015 p. 433–460. Report No.: 35. Available from: http:// www.who.int/wer *

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? VACCINE CONFIDENCE IN THE EU TRUST IS KEY, LET’S ACT TOGETHER

THE EU HAS AMONG THE LOWEST CONFIDENCE IN THE SAFETY AND EFFECTIVENESS OF VACCINES WORLDWIDE

SAFETY EFFECTIVENESS IMPORTANCE «I think vaccines are safe» «I think vaccines are effective» «I think vaccines are important»

69.9% 68.2% 66.3% 74.9% 72.7% 70.9% 85.5% 78.4% 75.9% France Latvia Bulgaria Poland Bulgaria Latvia Slovakia Bulgaria Poland

82.1% EU 86.5% EU 90% EU

Older age groups are more likely to be confident than younger age groups.

THE DOCTORS’ VIEWS Overall confidence in vaccines is high among general practitioners; especially in Germany, Romania, Spain and the UK. Female doctors in Germany and Poland are less likely to believe the seasonal is safe. In Poland and Spain general practitioners with more years in the profession are less likely to believe that measles- containing vaccination is important and safe.

Enhanced EU coordination to:

Ensure access to vaccination in all European countries. Make sure new and existing vaccines follow the highest safety standards. Share independent transparent information. Carry out more research and innovative new vaccines. Source: State of Vaccine Confidence in the EU 2018 report Source: State of Vaccine

For more information: ec.europa.eu/health/vaccination Learn about the confidence in your country with the Interactive Country Data Viewer: http://www.vaccineconfidence.org/ ™ @EU_Health #EUvaccines

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