Generation Gavi: Partnering to protect health through life-saving Generation Gavi: Partnering to protect health through life-saving vaccines

Contents

Forewords

Introduction: A partnership defined by impact

Advancing 20 years of progress

A Scaling innovation

B Strengthening health systems through programs

C Sustaining immunization

D Achieving a healthy vaccine ecosystem

Protecting the next generation: Our commitment

IFPMA and its members would like to thank Gavi for the use of its photography throughout this publication. 3 Generation Gavi: Partnering to protect health through life-saving vaccines Generation Gavi: Partnering to protect health through life-saving vaccines

Seth Thomas Berkley Cueni Chief Executive Officer Director General Gavi, the Vaccine Alliance International Federation of Pharmaceutical Manufacturers & Associations

Gavi, the Vaccine Alliance, Through Gavi’s public-private Today, Gavi supports vaccines As the world faces its first However, as Director From the near eradication of helps protect nearly half the partnership business model, against 17 infectious diseases, global pandemic in living General of the International , to the mass distribution world’s children against deadly it has fostered a unique with more already in the memory, affecting hundreds Federation of Pharmaceutical of the , and debilitating infectious collaboration between pipeline. Now it’s time for of millions of people around Manufacturers & Associations which offers protection to diseases. Since Gavi was industry and global health Gavi’s champions, investors, the world, it is not surprising (IFPMA), I see firsthand children from five major formed in 2000, its mission that has played a critical role partners and supporters to that global attention has fixed the impressive capabilities infectious diseases, the to save lives, reduce poverty in its success. Relentless carry the Alliance through its on the search for a vaccine, available today to research, partnership has extended the and protect the world against vaccine innovation has next five-year strategic period, which could help to control develop, manufacture and benefits of immunization to the threat of epidemics, enabled disease elimination, from 2021 to 2025. Together, the spread of the novel distribute safe, high-quality some of the poorest countries like COVID-19, has helped protection and prevention we’ve already vaccinated an coronavirus, COVID-19, and and effective vaccines. in the world and created a vaccinate more than 760 – and contributed towards entire generation of children the need to ensure equitable It is the same expertise generation of children who are million children in the world’s Sustainable Development – “Generation Gavi” – while access to new vaccines once and determination that has more likely to survive and thrive poorest countries. This has Goals on health, climate action, IFPMA and its members these have been developed. helped transform the health than ever before. not only helped save more gender equality, poverty and are working every day to In a matter of months, the of the world’s children, led to As we commence a new than 13 million lives in the long more. Over the past 20 years, encourage the discovery of pharmaceutical industry the rapid development of a chapter in the story of vaccine term, but has also generated IFPMA and its members have and access to new life-saving has been galvanized in an licensed vaccine and a further innovation, IFPMA, its affiliates more than USD$ 150 billion in nurtured Gavi’s potential into vaccines. Building on the unprecedented manner seven vaccine candidates and its members reaffirm their economic benefits in Gavi- something that has changed strength of this relationship, to quickly find innovative for Ebola, and that is behind commitment to supporting supported countries. None of the future for hundreds of we can deliver on our plans to solutions to contain and end a promising vaccine pipeline, Gavi’s mission to protect future this would have been possible millions of people. From the protect the next generation. It’s COVID-19, on the one hand, which includes research generations from disease. without the partnership of the very first Gavi-funded doses of an investment we can’t afford and by doing so in a way that in malaria, tuberculosis, As we share with you in the members of the International vaccine, which were to lose. is socially responsible on the multivalent meningitis following pages, much has Federation of Pharmaceutical administered in Mozambique other hand. and respiratory syncytial been achieved, but as we aim Manufacturers & Associations in 2001, and the approval of the virus (RSV). for securing the health and (IFPMA). in 2019, to the Using the latest technologies and leveraging deep and Such sustained vaccine wellbeing of all, there is more delivery of vaccines to remote that can be done to bring life- communities by autonomous collaborative networks across innovation lies at the heart of public and private sectors; our partnership with Gavi, the saving vaccines to those who drones in Rwanda and Ghana, need them the most, while also IFPMA is helping Gavi to laboratories, researchers and Vaccine Alliance. As a unique scientists around the world collaboration, the Alliance ensuring we protect the gains succeed and innovate. And of the past. Let science and by supporting the work of have mobilized to discover has been at the forefront of vaccine candidates and put combining vaccine innovation collaboration continue governments and civil society, to prevail. pharmaceutical manufacturers them into . The pace with sustained immunization are helping protect the most and progress of this work has programming. It is a We congratulate Gavi on its valuable resource on earth: surprised many commentators partnership that has solidarity twentieth anniversary and its children. and the watching world. at its heart. look forward to deepening our collaboration during the 2021 to 2025 strategic period.

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Gavi/2013/Evelyn Hockstein Richard Torbett Chief Executive The Association of the British Pharmaceutical Industry

Much has changed in the As Chief Executive of the In the months ahead, the world since Gavi held its last Association of the British shared ambition and expert replenishment conference in Pharmaceutical Industry, collaboration that has come 2015, not least the COVID-19 it is a privilege to showcase in to define Gavi will be needed global pandemic. these pages the commitment more than ever, as we work Against this unprecedented and contribution of our together to protect and backdrop, the UK will shortly members: companies at the advance the remarkable convene Gavi’s donors and cutting-edge of science, progress that has been partners to address the whose mission it is to tackle the achieved, and fight an urgent support and collaboration the world’s healthcare challenges. global health emergency. Alliance needs to achieve its The passion and commitment This new reality demands goals over the next five years. of our members here in the UK a renewed commitment to The UK is one of the six original and around the world mean working in partnership. Our donors to Gavi and continues we are in a unique position success in the years ahead, as to be a major supporter, having to support Gavi on the two in the past, will depend on the committed GBP £1.44 billion – most pressing fronts we face: strength of this collaboration. or almost a quarter of their total helping reach a further 300 There is no better time than million children in the next five funds – over the past five years. now to agree on how to protect Weji Ver Gavi/2015/Bart years with lifesaving vaccines In its lifetime, Gavi has future generations from and, together with the wider infectious disease. protected a generation of life sciences community, children; 760 million of whom playing our role in the response are more likely to survive and to COVID–19 by developing thrive into adulthood. vaccines, diagnostics With a world leading and treatments. pharmaceutical industry, and a longstanding commitment to Gavi, the UK is well placed to support the international cooperation needed to protect the world from infectious diseases.

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“More children have been immunized with a wider range of vaccines than at any time in history” The Investment Opportunity 2021-2025, Gavi

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Since its inception, Gavi has come to protect a generation of children; 760 million of them who are more likely to survive and thrive into adulthood.1

New vaccines are helping control HPV vaccines are protecting a New malaria vaccines are averting the spread of the deadly Ebola virus generation from HPV-related millions of deaths every year diseases, including cervical cancer The Advance Market Commitment The upcoming wP-IPV hexavalent has accelerated uptake of new combination vaccine will support the innovative vaccines, protecting achievement of the polio endgame millions of children against Gavi/2011/Christine McNab pneumococcal disease

Established in 2000 to provide As Gavi marks its twentieth anniversary, Research-based vaccine companies children everywhere with protection one remarkable achievement stands have a long track record of research from infectious diseases, Gavi, the out among many, that more children and development for diseases Vaccine Alliance has grown to become have been immunized with a wider disproportionately affecting the A a powerful partnership between range of vaccines than at any time poorest countries. Members are public and private organizations. in history.3 contributing to the on-going goal of Through a unique operating model, the As founding partners, International polio eradication, the control of malaria Alliance has harnessed the expertise Federation of Pharmaceutical and diarrheal diseases, and more of a wide range of organizations, Manufacturers & Associations (IFPMA) recently the rapid response to the including vaccine manufacturers, member companies have made the Ebola outbreak, with the first vaccine research institutes, civil society groups significant long-term investments being prequalified by the World Health Partnership and public health authorities. The Organization (WHO) in November needed to both manufacture a reliable combined strength and collaboration supply of existing vaccines and to 2019, and the ongoing race to develop of Alliance members has increased develop a robust pipeline of innovative a vaccine against COVID-19. The the uptake of life-saving vaccines, new vaccines. Today, IFPMA members benefits of the partnership to scaling enabling the benefits of immunization provide 13 vaccine formulations and vaccine innovation is clear: Gavi to be extended to some of the poorest presentations to Gavi countries for use provides aggregated demand and 2 around the world. in routine immunization, preventative secured financing for the purchase Defined 4 of vaccines, which enables IFPMA’s campaigns and emergency stockpiles. innovative biopharmaceutical members to scale-up vaccine manufacturing capacity to supply the By Impact volumes required. 10 11 Generation Gavi: Partnering to protect health through life-saving vaccines Generation Gavi: Partnering to protect health through life-saving vaccines

Gavi/2013/Bart Ver Weji As the partnership enters its next Taking into account healthcare costs, strategic period (2021-2025), IFPMA and its members will stand lost wages and productivity due to with Gavi in support of our collective ambition to roll out the most As one of Gavi’s longest standing illness, as well as the broader benefits comprehensive package of protection partners, IFPMA members will continue of people living longer, healthier lives, to date to the world’s poorest countries their support to bring long-term vaccine and vaccinate the remaining 20% of sustainability to the world and expand there is US$ 54 returned on every children around the world without the availability of vaccines to fight the US$ 1 invested in immunization in 6 access to new vaccines. 18 diseases targeted by Gavi in the next 8 7 Gavi-supported countries. As we live through the current and period, compared with just 6 in 2000. unprecedented COVID-19 global health Building on this shared impact, IFPMA emergency, we are reminded daily members are in a unique position to of the importance of partnership and support Gavi’s key goals during the collaboration between the public and 2021-2025 strategic period. In the private sectors to achieve global health following pages, we look at some of security and improved health outcomes the achievements that position IFPMA Vaccines remain for individuals and families.It also members to support Gavi to scale underscores the important work Gavi vaccine innovation, strengthen health has done to build stronger and more systems, sustain immunization and resilient healthcare systems. achieve a healthy vaccine ecosystem. Today, IFPMA members’ engagement one of the most with Gavi extends beyond vaccine manufacture and supply; it ranges from vaccine development, testing, production, storage, and distribution, to supporting national procurement, cost-effective ways ensuring health systems have the capacity to deliver and administer vaccines, training for healthcare workers and immunization managers, and building the capacity of vaccine to save lives and manufacturers in the global south. This work has not only produced life-saving vaccines, it has helped to increase access to them through the development and introduction of state- promote good of-the-art vaccine packaging, storage and distribution solutions. These innovations have led to reductions in the number of vaccines that need to be refrigerated, improved effectiveness, health and and reduced the number of required shots through combination vaccines. However, there are growing challenges that threaten to undermine this hard-won progress. From a rise in well-being. outbreaks of vaccine-preventable diseases, such as measles and yellow fever, to the growing consequences of climate change, pollution, migration Gavi/2019/Tony Noel and humanitarian crises,5 the mission By preventing illness, death and of Gavi is as relevant today as it was in 2000 when the Alliance was launched. long-term disability, Gavi-supported vaccines have helped generate more than US$ 150 billion in economic benefits between 2000 and 2017.9 12 13 Generation Gavi: Partnering to protect health through life-saving vaccines Generation Gavi: Partnering to protect health through life-saving vaccines

Scaling Polio cases have fallen Vaccine by over Innovation 99% Gavi/2018/Duncan Graham-Rowe During the last 20 years of Gavi, IFPMA And innovation hasn’t stopped there, Since 1988, IFPMA members have members have invested in a sustained as IFPMA members have developed been a key partner in the Global Polio program of vaccine innovation that and scaled new combination, liquid and Eradication Initiative (GPEI), which now Working with UNICEF and Gavi, IFPMA members Sanofi Rotavirus vaccines, which protect against the deadliest has helped transform the health of the heat stable vaccines and transformed works closely with Gavi to strengthen Pasteur and GSK have provided billions of doses of polio form of diarrhea in young children, have protected more world’s children. Today, vaccines exist the supply chain over the last 20 years. routine immunization systems. Through vaccines and have supported the rollout to children than 100 million children with the help of Gavi and its that prevent and control a wide range of This innovation has improved coverage, significant research breakthroughs, around the world through an unprecedented worldwide partners. There are now 45 Gavi-supported countries infectious diseases that have historically equity and extended the benefits of IFPMA members have developed registration program. is the largest IPV using cost-effective rotavirus vaccines to safeguard been the leading cause of childhood immunization to those who need it most. inactivated polio vaccines (IPV) to manufacturer, supplying 80% of the IPV doses delivered children.17 Using rotavirus vaccines in Gavi-supported 13 mortality, including polio, measles, One of the greatest achievements of our supplement and eventually replace live to UNICEF. More recently, to achieve and sustain a countries could prevent 180,000 deaths and save 10 18 malaria, rotavirus and pneumonia. time is the development of multiple polio oral polio vaccines (OPV) - this is in line polio-free world, Sanofi Pasteur has been working on USD$ 68 million in treatment costs every year. Building on this important success, vaccines delivered through sustained with the GPEI driven transition to remove the development of an IPV and whole cell pertussis 12 over the last decade or so, several new immunization campaigns. Before the wild polio virus from communities. containing hexavalent vaccine, specifically designed for Different presentations of these Gavi countries14 and lower-and middle-income countries vaccines have been introduced with the availability of vaccines, polio was the As a long-standing partner in the fight for the prevention vaccines have increased ease of storage, (LMICs). This more advanced combination vaccine will help of Gavi and IFPMA members. This leading cause of permanent disability and epidemic control of meningitis, IFPMA members administration, and manufacturing help LMICs to strengthen their pediatric immunization new generation of vaccines are targeting in children. With effective vaccines are supporting the implementation of the “Defeating according to the program’s needs. programs and maintain the high IPV coverage across the specific diseases such as meningitis, developed and accessible, health Meningitis 2030 Roadmap” through the development, pediatric population (along with higher DTP3 coverage). neglected infectious diseases like Ebola, policymakers began to work towards manufacture and supply of innovative conjugated and This combined vaccine will also contribute towards non-communicable diseases such as the polio eradication. The number of wild multivalent vaccines.19 human papillomavirus (HPV), and a new poliovirus cases has fallen by over 99% maintaining a polio-free world. , RTS,S. On the horizon since 1988 , taking polio to the brink of are vaccines for new targets such as the eradication. It is a powerful example of respiratory syncytial virus (RSV). how vaccine innovation and partnership Thanks to the pneumococcal Advance Market Malaria is among the world’s most serious global health can come together to help eliminate a Commitment (AMC), an innovative funding mechanism challenges, causing hundreds of millions of deaths each disease across the world. 11 and donor commitments have enabled Gavi, GSK & Pfizer year, mostly among young children in Sub-Saharan Africa.20 to support the scale-up of manufacturing to ensure the Following decades of research and development, IFPMA introduction of the pneumonia vaccine for children in the member GSK, in partnership with PATH, a global health world’s poorest countries.15 This innovative partnership organization, developed a vaccine that is now part of has prevented the deaths of over half a million children in routine immunization programs. Research continues, with developing countries over the past decade. Since 2007, GSK committing more than USD$ 300 million for the total with the support of Gavi, 183 million children have received remaining development and manufacturing costs, and the pneumococcal (PCV), which phase IV studies that will continue to assess the safety, protects against the leading cause of pneumonia. This effectiveness and impact of the vaccine. 21 program has prevented more than 1.5 million childhood deaths. coverage in Gavi-supported countries has now reached 41%, up from 35% in 2015 and almost equals the global average of 42%.16

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Gavi/2009/Olivier Asselin Gavi/2015/Phil Moore Neglected infectious diseases, such Other vaccine innovations in progress In a key breakthrough, Sanofi Pasteur as Ebola, that occur in developing include: multivalent conjugated has developed a controlled temperature countries can hinder the advancement meningitis vaccines, respiratory chain (CTC) for the that of the world to better health. The drive syncytial virus (RSV) monoclonal allows it to reach the last mile. Using an to develop a vaccine for the Ebola virus antibodies and pandemic influenza innovative approach, vaccines shows what health authorities, the preparedness, including an can be kept at temperatures outside pharmaceutical industry and alliances assessment of potential vaccine supply of the traditional cold chain of +2°C like Gavi can do when faced with a and demand interventions. to +8°C for a limited period under public health crisis. But innovation isn’t limited to the monitored and controlled conditions. research and development of vaccines. In addition, Sanofi Healthcare India “There is now one IFPMA members are using their Private Ltd has received WHO licensed Ebola vaccine expertise and innovation to constantly approval for use at temperatures as and seven candidate improve the logistical challenges of high as 40°C for up to 14 days; this storing and transporting vaccines. This development is a real game-changer Ebola vaccines 34 ‘cold-chain’ system is critical to moving in vaccines management. at different phases vaccines at the correct temperatures Introducing and scaling-up vaccines of development” from the point of manufacture to the requires sustained and continued point of use. Vaccines often have specific investment, something that Gavi is When a large and complex outbreak storage requirements for maintaining committed to achieving. And, while an of Ebola occurred in West Africa in vaccine potency, and the logistics of incredibly important part of the story, 2014 - resulting in 11,300 deaths in these can be especially hard to sustain in innovation in vaccines needs to work in But innovation has not only been the region - WHO declared Ebola an Resulting from this period of rapid The success of vaccines in preventing reaching the remotest parts of the world. tandem with the strengthening of health international public health emergency. limited to the development of vaccines innovation and collaboration, there disease means that the demand for For example, IFPMA members and immunization services, something for individual infectious diseases. To WHO developed a plan to fight the is now one licensed Ebola vaccine new innovative vaccines remains we look at in the following pages. disease, including fast-tracking Pfizer and GSK have helped address overcome the low uptake in low-income and seven candidate Ebola vaccines high. One disease area that remains cold-chain challenges through countries of separate vaccines against access to experimental treatments at different phases of development. a target for vaccine innovation is 23 innovative work in packaging. While , , , and vaccines. To address the crisis Together, with an approved vaccine, malaria, which causes 435,000 in West Africa, IFPMA members such Pfizer has developed a multi-dose vial hepatitis B and these coordinated efforts will help deaths each year, mostly among young (MDV) for its as GSK, MSD and Johnson & Johnson 28 type b, IFPMA members, including control the Ebola outbreak in children in Africa. To see if RTS,S, that significantly reduces storage undertook efforts to accelerate the 26 GSK, Sanofi Pasteur and Johnson & West Africa. a vaccine that has shown in clinical requirements and shipping costs, 31 Johnson, have developed an all-in-one development of Ebola vaccines in trials to significantly reduce malaria in collaboration with other stakeholders Alongside their commitment to GSK has developed a new four-dose vaccine that protects against all five of communicable diseases, scientists children, is effective under real world vial presentation of its pneumococcal these major diseases. These innovative including with WHO, the Innovative conditions, it was introduced in 2019 Medicine Initiative, U.S. National have been exploring new approaches vaccine to help address cold-chain combination vaccines - some of them to vaccines for non-communicable in Ghana, Kenya and Malawi through challenges, and a new blow-fill-seal not requiring reconstitution - reduced Institute of Allergy and Infectious a WHO-coordinated pilot program. Disease (NIAID), BARDA and others.24 diseases such as cancer, particularly technology to deliver compact, single- cold chain storage requirements and following the breakthrough discovery The program is supported by Gavi dose rotavirus vaccines. 32 were easier to administer than the Highlighting the effective policy tools and several other organizations, available to Gavi, the Alliance offered a that cervical cancer can be caused by Nine Gavi countries are now using the earlier reconstituted combinations. the human papillomavirus (HPV). including GSK, the vaccine’s developer In 2001, Gavi began making the liquid new Advance Purchase Commitment and manufacturer, who is donating new four-dose vial pneumococcal pentavalent vaccine part of routine to all manufacturers working on Since that important discovery, IFPMA 10 million vaccine doses.29 There is vaccine. The blow-fill-seal tube 25 immunization programs; by 2018, candidate vaccines in Phase I+. members, MSD and GSK, have gone also progress on a new vaccine for innovation has reduced the amount more than 467 million children had on to develop vaccines that protect typhoid, developed by GSK Vaccines of space required by 30 percent, been immunized.22 against 70%-90% of cervical cancer Institute for Global Health (GVGH) and as compared with the previous cases. Besides the HPV vaccine, which transferred in 2013 under a licensing presentation. 33 These innovations leave Gavi/2009/Oliver Asselin prevents not only cervical cancer, but agreement to Biological E Ltd, an Indian more cold chain space available for also vaginal, vulvar and anal cancer, biotechnology company. 30 If approved transporting and storing more vaccines there is one other globally approved for prequalification by WHO, the vaccine - ultimately protecting more children cancer prevention vaccine – the will be eligible for use in endemic regions from rotavirus and other vaccine- that helps prevent under the Gavi umbrella. preventable diseases. liver cancer.27

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Strengthening Health Systems To expand and deliver access to life- MSD established a grant program Other partnerships and innovations saving vaccines, particularly to those to help communities in low-income have also ensured that life-saving communities underserved and under countries design, implement, and vaccines are accessible to everyone immunized, IFPMA members assist evaluate HPV vaccination programs who needs them, no matter where Gavi/2010/Riccardo Gangale Gavi/2014/Duncan Graham Rowe Gavi-supported countries to develop with the goal of developing a successful they live. In a partnership with the sustainable vaccination programs that adolescent immunization model. The International Rescue Committee (IRC) harness partnerships and innovation. program included the aid of leading and Google, the Pfizer Foundation “Pfizer has also teamed In addition to innovative programs For example, GSK’s candidate vaccine Consider efforts to eliminate cervical experts to navigate barriers, while MSD has run the mReach program, a up with Zipline, Gavi, the that have enabled vaccines to reach against tuberculosis is the first in donated over 1.3 million free doses to technology-enabled platform that excluded and remote communities, more than a century to demonstrate cancer caused by the human Bill and Melinda Gates papillomavirus (HPV). The majority of 25 institutions in 21 countries. Using its enables healthcare workers to IFPMA members have supported Gavi’s substantial protection against the HPV cases and deaths from cervical experience from the program, MSD identify children who require follow- Foundation and the UPS efforts to strengthen health systems disease and is now licensed to the Bill cancer occur in low-income countries, also established HPV immunization up regarding . During Foundation to support through stronger, more sustainable & Melinda Gates Medical Research programs in other areas, such as the two-year project implementation especially in Africa. Without better the Government of Ghana national immunization programs. GSK Institute (MRI) for further development. cervical cancer prevention and control, Bhutan and Rwanda. With support period in Uganda, a total of 12,949 has, for example, contributed If successful, this vaccine could 39 41 deaths were expected to rise to from MSD, each country successfully (74%) out of 17,454 children under the in establishing a medical GBP£ 1.2 million to the STEP program, help save millions of lives globally. 416,000 by 2035. IFPMA members, completed a national roll-out of school- age of one were immunized as a result drone delivery system” which builds skills among local Similarly, in 2013, GSK transferred a 37 MSD and GSK, having developed based vaccination programs, with each of project activities. Pfizer has also immunization supply chain managers new to Biological E vaccines that protect against 70%- achieving greater than 90% vaccine teamed up with Zipline, Gavi, the Bill and in Gavi countries, and has, since 2019, Ltd. Having already received market 35 90% of cervical cancer cases, then coverage in their first year. Melinda Gates Foundation and the UPS committed GBP £1.5 million over three authorization from the Indian Health supported national vaccination Likewise, GSK, working with Gavi, Foundation to support the Government years to a GSK-Save the Children Regulatory Agency, if approved by programs in the low-income countries has distributed 1.9 million doses of its of Ghana in establishing a medical partnership focused on strengthening WHO, the vaccine will be eligible for use that needed the vaccine the most. HPV vaccine, dramatically reducing drone delivery system to ensure access immunization programs in the Somali in endemic regions under the 40 42 the risk of cervical cancer for some to routine vaccines and essential region of Ethiopia. Johnson & Gavi umbrella. medicines in some of the country’s 855,000 girls in Cambodia, São Tomé Johnson has also supported the STEP Thanks to public-private partnerships, most hard-to-reach areas.38 and Zimbabwe by preventing HPV program by enabling supply chain IFPMA member Sanofi Pasteur has . Zimbabwe, which suffers the experts from the company to train local also performed several industrial fifth highest rate of cervical cancer in supply chain managers in several technology transfers to vaccine the world, introduced HPV vaccines Gavi countries. manufacturers in middle-income into the country’s routine immunization Further, IFPMA members now also countries (MICs). These transfers help program in 2018, and, with a supply of transfer vaccine innovation technology build local capacities and respond to the necessary doses, is closer to its to those institutions able to support its domestic vaccine needs such as ex IPV goal of immunizing more than 800,000 successful rollout across the countries Biopharma and the hexavalent vaccine girls across the country. 36 and communities where they are in South Africa.43 needed most.

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Gavi/2013/Adrian Brooks Gavi/2016/Duncan Graham-Rowe Gavi/2013/Adrian Brooks Gavi/2016/Kate Holt

The remaining critical component to Through stockpiling, IFPMA members Since 2017, greater global collaboration strengthening health systems and manufacture, reserve and make has led to the creation of the Coalition immunization programs, is preparing available vaccine doses in case of for Epidemic Preparedness and to deal with epidemics or even outbreaks. Between 2006 and 2019, Innovations (CEPI). This new public- new pandemic threats, such as the Gavi-supported stockpiles have private collaboration aims to better one the world is now experiencing helped immunize more than 90 million coordinate the development of future with the far-reaching spread of the people.45 For example, due to the vaccines against targeted epidemic novel coronavirus, COVID-19. In recent outbreak of the Ebola virus in pathogens identified by WHO. As a addition to the efforts to discover an the Democratic Republic of the Congo, partner since CEPI’s launch at Davos effective vaccine to protect against Gavi increased the global emergency in 2017, IFPMA members have shared COVID-19, IFPMA members are stockpile of Ebola vaccines to 500,000 vaccine research and development already contributing to proposals and doses, up from 300,000 doses. 46 In experience and expertise, and discussions around the feasibility and addition, IFPMA members have been committed to CEPI through its Scientific potential for launching new vaccine long-standing partners for epidemic Advisory Committee to continue delivery innovations that would enable preparedness, contributing to WHO’s sharing scientific knowledge and the provision of vaccines safely and stockpile of meningococcal disease, collaborate towards the development effectively at scale.44 yellow fever and cholera vaccines of vaccines for unmet needs. Gavi/2016/Kate Holt To prepare health systems and the since 2004 . Building on this work and to support global community to act swiftly and With additional investment and a brand- Gavi’s strategic goals over the period Gavi-supported stockpiles effectively to epidemic threats, Gavi, new facility, Sanofi Pasteur has doubled 2021-2025, IFPMA members plan to IFPMA members and other global its capacity to respond to public health be a significant collaborator not only health stakeholders have already made emergencies. This investment allowed by sustaining vaccine innovation and have helped immunize more than significant investments and devoted a supply of four million doses of yellow developing and supplying vaccines, considerable resources to multi- fever in a record time to Angola during a but through further supply chain year immunization projects involving previous outbreak. 47 innovation, technology enabled manufacturing, stockpiling, and system immunization programming and preparedness. Stockpiling vaccines pandemic preparedness. makes it possible to quickly respond to outbreaks of infectious diseases; that’s why IFPMA members, mainly 90 million led by Sanofi Pasteur, contribute to the global vaccine stockpiles that mitigate the risk posed by infectious, epidemic diseases, including yellow fever, people cholera, meningitis and other diseases.

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Gavi/2012/Olivier Asselin Gavi/2015/GMB Akash Gavi/2014/Duncan Graham Rowe

Gavi/2013/Jiro Ose Key areas for continued collaboration to improve the sustainability of immunization programs include improving procurement capacity, demand predictability and volume commitments. That’s why IFPMA and its members engage in multi- partner platforms to provide technical assistance and build capacity around the manufacturing and forecasting processes needed to supply vaccines in the right amounts at the right time. Consistent and accurate visibility into long-term demand forecasting is key to supply security. Developing Over the period 2021-2025, there future solutions will require a better is an opportunity to support Gavi understanding of each country’s countries in ensuring sustained national vaccine procurement practices. immunization programs can serve Sustaining In addition, IFPMA and its members, as a foundation for delivering and working alongside other key global expanding essential primary healthcare health partners, will continue to act services, while also tackling other key as advocates in driving political will health threats, such as antimicrobial for vaccination. Maintaining and resistance. We recognize, however, strengthening national commitments that countries will be challenged in to immunization is critical to protecting the months, and potentially years, Immunization To meaningfully and sustainably extend and advancing the health of people ahead as the COVID-19 pandemic the benefits of immunization to those around the world, particularly for those spreads and disrupts the provision of most in need, programs should be built communities currently underserved. routine immunization. We therefore upon the unique needs of the country Sustained, resilient immunization welcome the quick leadership of WHO – including its immunization system programs are central to achieving in providing guidance on managing maturity, economic situation, political Gavi’s mission, but also the goals of the and protecting immunization services will and ability to measure the burden new Immunization Agenda 2030 and during national responses to the Programs of disease and impact of the Sustainable Development SARS-CoV-2 virus.50 IFPMA and its vaccine introduction. The goal of Goals (SDGs). 49 members, working with Gavi and other sustainable vaccination should be partners, will use our collective medical a progressive transition from Gavi expertise to support global healthcare support towards fully self-sufficient, systems to manage the unprecedented country-adapted and evidence-based increase in pressure they are immunization programs for countries’ currently experiencing . populations. Gavi’s rising support for industry’s expanding portfolio of vaccines has enabled countries to build the capacity needed to conduct over 400 vaccine introductions and campaigns, and contain numerous disease outbreaks.48

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Gavi/2013/Adrian Brooks Achieving A Healthy Gavi/2014/GMB Akash Vaccine Ecosystem

A healthy ecosystem for vaccines Sustained collaboration across these There are also projects underway to is crucial to support sustainable underlying regulatory, infrastructure, deploy vaccine adjuvants that improve innovation, demand and supply. As financing and supply issues will vaccine efficacy and reduce the part of a healthy vaccine ecosystem, be crucial if we are to strengthen amount of vaccine antigen required IFPMA members, through their healthcare systems, identify per dose, allowing more vaccine significant long-term investments in sustainable financing mechanisms, doses to be produced and therefore a robust pipeline of innovation, health and reduce the add-on costs of health contributing to the protection of more partnerships and supply capacity, products and services along the people. Progress is also being made are supporting countries to meet supply chain. in the manufacturing processes demand, achieve their specific vaccine Ensuring a healthy vaccine ecosystem for developing and manufacturing preferences and build supply security. is also critical for the future introduction vaccines. For example, IFPMA member Gavi’s role is crucial in this, sharing of new vaccines. In the near future, Sanofi Pasteur is developing a new insights on vaccine demand, helping vaccine development will benefit as generation of yellow fever cell culture to secure financing, enabling the we better understand pathogens and technology that has been shown to purchasing of vaccines and preparing immune responses, while research speed up, improve robustness, and IFPMA members for the scale-up of will also benefit from smarter platform simplify the manufacturing process. manufacturing capacity when it technologies and the increased use of This, in turn, will enable us to better is needed. advanced data analytics. For example, control the disease and rapidly respond Policymakers can support a well- vaccines that use messenger RNA to outbreaks and epidemics. balanced vaccine ecosystem (mRNA) can guide cells to prevent IFPMA members are at the forefront of through continuing to work together disease, as well as offer flexible design, such developments and will continue to secure the key components of a cost-effective production and applying their expertise to develop strong manufacturing supply chain, safer administration. effective, safe and high-quality including: ensuring a fair return vaccines. In partnership with Gavi, through tiered pricing, more long- the principles of a healthy ecosystem term accurate demand forecasts, can ensure the continued success of flexible procurement practices, and scaling vaccine innovation to save lives, convergence of regulatory, packaging protect health and prevent the spread and labelling requirements. of disease.

24 Gavi/2019/Isaac Griberg 25 Generation Gavi: Partnering to protect health through life-saving vaccines Generation Gavi: Partnering to protect health through life-saving vaccines

“In the final decade of the SDGs, Gavi can provide prevention, protection and prosperity to hundreds of millions more communities and families...... With the political will and investment of countries and the ingenuity of Gavi and its partners, including its donors, we can achieve a world where vaccines work for all.” The Investment Opportunity 2021-2025, Gavi

26 27 Generation Gavi: Partnering to protect health through life-saving vaccines Generation Gavi: Partnering to protect health through life-saving vaccines

IFPMA and its members make five major commitments to support Gavi’s mission to reach 300 million more Protecting children with the full protection of the broadest vaccine portfolio in history:

Bring to life new vaccine solutions that save lives, protect health and 01 prevent the spread of disease The Next

Reach the most in need and underserved by innovating throughout the supply chain Generation: 02 and ensuring the availability of high-quality vaccines to meet existing and growing demand

Support the strengthening, Our sustainability and resilience of 03 national immunization services

Commitments Prepare for public health emergencies to ensure the rapid sharing of information, the deployment Gavi/2019/Ojwok 04 of scientific expertise and the delivery of vaccines The mission of Gavi, the Vaccine Working together, we can for use in outbreak responses Alliance continues to inspire and scale vaccine innovation motivate IFPMA members, including the world’s leading research-based through sustained vaccine manufacturers. immunization, to ensure no Partner to share capabilities, By uniting partners around a bold and one is left behind. expertise and maximize the impact ambitious agenda, Gavi has supported 05 of life-saving vaccines nearly half the world’s children to be protected against deadly and debilitating infectious diseases. To grow our collective impact over the next five years, IFPMA members commit to innovate new “We pledge to play our part in protecting vaccine solutions, reach the most in need and underserved, support the health of the next generation” the strengthening of immunization services, prepare for public health GSK Corporate Brand emergencies, and partner to Terms of use maximize impact.

3. Termination

a. We may terminate or modify your licence to use the GSK Brand at any time upon written notice to 28 you. Following a notice of termination from us, you agree to immediately stop using the GSK Brand. 29

b. Paragraphs 2 and 4 of these Terms will survive any termination.

4. Miscellaneous

a. These Terms will be governed by and construed in accordance with the laws of England and Wales. You and GSK hereby submit to the exclusive jurisdiction of the courts of England and Wales in relation to any dispute arising out of or in connection with these Terms.

b. These Terms constitute the entire agreement between you and GSK and supersede all previous agreements relating to the subject matter.

c. Your rights and obligations under these Terms will not be assignable or otherwise transferable by you without our express written approval and any such assignment or transfer without such approval will be null and void.

Name: Date:

Signature:

Please sign and return form to [email protected]

GSK Corporate Brand Terms of Use – July 2019 2 Generation Gavi: Partnering to protect health through life-saving vaccines

1. Gavi, the Vaccine Alliance, ‘Prevent, Protect, Prosper: 19. World Health Organization, ‘Defeating meningitis by 37. The International Federation of Pharmaceutical 2021-2025 Investment Opportunity’, accessed 2030: Development of the Roadmap’, accessed April Manufacturers & Associations, ‘Increasing Access April 2020 https://www.gavi.org/sites/default/ 2020 https://www.who.int/emergencies/diseases/ to Vaccines in Rural and Urban Settings with mTech’, files/publications/2021-2025-Gavi-Investment- meningitis/en/ accessed April 2020, https://www.ifpma.org/global- Opportunity.pdf health-matters/increasing-access-to-vaccines-in- 20. World Health Organization, ‘Malaria: Key Facts’, rural-and-urban-settings-with-mtech/ 2. Gavi, the Vaccine Alliance, ‘Gavi@20 The story of an accessed April 2020 https://www.who.int/en/news- Alliance that today protects half the world’s children’, room/fact-sheets/detail/malaria 38. Gavi, the Vaccine Alliance, ‘Ghana launches the world’s accessed April 2020 https://www.gavi.org/sites/ largest vaccine drone delivery network’, accessed 21. Kaslow et al. ‘Vaccine candidates for poor countries default/files/publications/Gavi_at_20_years.pdf May 2020 https://www.gavi.org/news/media-room/ are going to waste’, Nature. 2018. Vol. 564 (337). Page ghana-launches-worlds-largest-vaccine-drone- 3. Gavi, the Vaccine Alliance, ‘Prevent, Protect, Prosper: 339, accessed May 2020 https://media.nature.com/ delivery-network 2021-2025 Investment Opportunity’, accessed original/magazine-assets/d41586-018-07758-3/ April 2020 https://www.gavi.org/sites/default/ d41586-018-07758-3.pdf 39. The International Federation of Pharmaceutical files/publications/2021-2025-Gavi-Investment- Manufacturers & Associations, ‘Global Health 22. Gavi, the Vaccine Alliance, ‘Pentavalent Vaccine Opportunity.pdf Progress: Strategic Training for Executives Support’, accessed May 2020, https://www.gavi.org/ Programme (STEP), accessed April 2020 https:// 4. UNICEF, ‘Pricing Data’, accessed May 2020 https:// types-support/vaccine-support/pentavalent globalhealthprogress.org/collaboration/strategic- www.unicef.org/supply/pricing-data 23. World Health Organization, ‘Modernizing the arsenal training-for-executives-programme-step/ 5. World Health Organization, ‘Ten threats to global of control tools: Ebola vaccines’, accessed April 2020 40. GSK, ‘Save the Children Partnership’, accessed May health in 2019’, accessed April 2020 https://www.who. https://www.who.int/csr/disease/ebola/one-year- 2020 https://www.gsk.com/en-gb/about-us/save- int/news-room/feature-stories/ten-threats-to-global- report/vaccines/en/ the-children-partnership/ health-in-2019 24. The International Federation of Pharmaceutical 41. GSK, ‘GSK licenses tuberculosis vaccine candidate 6. Gavi, the Vaccine Alliance, ‘Preven, Protect, Prosper: Manufacturers & Associations, ‘Ebola’, accessed May to the Bill & Melinda Gates Medical Research Institute 2021-2025 Investment Opportunity’, accessed 2020 https://www.ifpma.org/subtopics/ebola/ for continued development’, accessed May 2020 April 2020 https://www.gavi.org/sites/default/ 25. Gavi, the Vaccine Alliance, ‘Ebola vaccine purchasing https://www.gsk.com/en-gb/media/press-releases/ files/publications/2021-2025-Gavi-Investment- commitment from Gavi to prepare for future gsk-licenses-tuberculosis-vaccine-candidate-to-the- Opportunity.pdf outbreaks’, accessed May 2020 https://www.gavi. bill-melinda-gates-medical-research-institute-for- 7. Gavi, the Vaccine Alliance, ‘Prevent, Protect, Prosper: org/news/media-room/ebola-vaccine-purchasing- continued-development/ 2021-2025 Investment Opportunity’, accessed commitment-gavi-prepare-future-outbreaks 42. Biological E Limited, ‘K T Rama Rao Inaugurates BE’s April 2020 https://www.gavi.org/sites/default/ 26. World Health Organization, ‘Major milestone for Plant at Genome Valley & Unveils Typhoid Conjugate files/publications/2021-2025-Gavi-Investment- WHO-supported Ebola vaccine’, accessed April 2020 Vaccine, accessed May 2020 http://www.biologicale. Opportunity.pdf https://www.who.int/news-room/detail/18-10-2019- com/news.html 8. Gavi, the Vaccine Alliance, ‘Fact & Figures’, accessed major-milestone-for-who-supported-ebola-vaccine 43. Biovac, ‘Biovac tech transfer with Sanofi Pasteur’, May 2020 https://www.gavi.org/programmes- 27. World Health Organization, ‘Human Papillomavirus accessed May 2020 http://www.biovac.co.za/biovac- impact/our-impact/facts-and-figures (HPV) and Cervical Cancer’, accessed April 2020 tech-transfer-with-sanofi-pasteur/ 9. Gavi, the Vaccine Alliance, ‘Fact & Figures’, accessed https://www.who.int/news-room/fact-sheets/detail/ 44. The International Federation of Pharmaceutical May 2020 https://www.gavi.org/programmes- human-papillomavirus-(hpv)-and-cervical-cancer Manufacturers & Associations, ‘COVID-19: The impact/our-impact/facts-and-figures 28. World Health Organization, ‘Malaria: Key Facts’, biopharmaceutical industry is leading the way in 10. World Health Organization, ‘Children: Reducing accessed April 2020 https://www.who.int/en/news- developing vaccines, treatments & diagnostics’ Mortality’, accessed May 2020 https://www.who.int/ room/fact-sheets/detail/malaria accessed April 2020 https://www.ifpma.org/covid19/ news-room/fact-sheets/detail/children-reducing- 29. World Health Organization, ‘Malaria vaccine pilot 45. Gavi, the Vaccine Alliance, ‘Prevent, Protect, Prosper: mortality launched in Malawi’, accessed March 2020 https:// 2021-2025 Investment Opportunity’, accessed 11. World Health Organization, ‘10 Facts on Polio www.who.int/news-room/detail/23-04-2019- April 2020 https://www.gavi.org/sites/default/ Eradication’, accessed April 2020 https://www.who. malaria-vaccine-pilot-launched-in-malawi files/publications/2021-2025-Gavi-Investment- int/features/factfiles/polio/en/ Opportunity.pdf 30. GKS, ‘Inside the Vaccines Institute for Global Health’, 12. World Health Organization, ‘Immunization, Vaccines accessed May 2020 https://www.gsk.com/en-gb/ 46. Gavi, the Vaccine Alliance, ‘Gavi Board Approves New and Biologicals: IPV Introduction, OPV Withdrawal and responsibility/inside-the-gvgh/ Ebola Vaccine Programme’ accessed April 2020 Routine Immunization Strengthening, accessed April https://www.gavi.org/news/media-room/gavi-board- 31. Pfizer, ‘Pfizer Receives World Health Organization 2020 https://www.who.int/immunization/diseases/ approves-new-ebola-vaccine-programme Prequalification for Multi-Dose Vial Presentation of poliomyelitis/endgame_objective2/en/ Prevenar 13®, accessed May 2020 https://www.pfizer. 47. World Health O rganization, ‘Yellow fever global 13. Sanofi Pasteur, ‘Access to Vaccines’, accessed May com/news/press-release/press-release detail/pfizer_ vaccine stockpile in emergencies’, accessed May 2020 https://www.sanofi.com/-/media/project/ receives_world_health_organization_prequalification_ 2020 https://www.who.int/news-room/feature- one-sanofi-web/websites/global/sanofi-com/ for_multi_dose_vial_presentation_of_prevenar_1 stories/detail/yellow-fever-global-vaccine-stockpile- home/common/docs/download-center/access_to_ in-emergencies 32. GSK, ‘GSK receives World Health Organization vaccines_2018.pdf/ Prequalification for Synflorix pneumococcal vaccine 48. Gavi, the Vaccine Alliance, ‘Prevent, Protect, Prosper: 14. Gavi, the Vaccine Alliance, ‘Gavi Board starts framing four-dose vial’, accessed May 2020 https://www.gsk. 2021-2025 Investment Opportunity’, accessed Alliance’s approach to 2021-2025 period’, accessed com/en-gb/media/press-releases/gsk-receives- April 2020 https://www.gavi.org/sites/default/ May 2020 https://www.gavi.org/gavi-board-starts- world-health-organization-prequalification-for- files/publications/2021-2025-Gavi-Investment- framing-alliance-s-approach-to-2021-2025-period synflorix-pneumococcal-vaccine-four-dose-vial/ Opportunity.pdf

15. Gavi, the Vaccine Alliance, ‘World’s poorest 33. Gavi, the Vaccine Alliance, ‘Product information for 49. World Health Organization, ‘Immunisation Agenda children among first to receive new life-saving vaccines and cold chain equipment: Detailed product 2030: A Global Strategy To Leave No One Behind’ pneumococcal vaccines’, accessed April 2020 profiles slide kit’, accessed May 2020 https://www. accessed April 2020 https://www.who.int/ https://www.gavi.org/news/media-room/worlds- gavi.org/our-alliance/market-shaping/product- immunization/immunization_agenda_2030/en/ poorest-children-among-first-receive-new-life- information-vaccines-cold-chain-equipment 50. World Health Organization, ‘Protecting lifesaving saving-pneumococcal-vaccines. 34. World Health Organization, ‘WHO Prequalified immunization services during COVID-19: New 16. Gavi, the Vaccine Alliance, ‘Fact & Figures’, accessed Vaccines: Cholera: Inactivated Oral’, accessed guidance from WHO’ accessed May 2020 https:// May 2020 https://www.gavi.org/programmes- April 2020 https://extranet.who.int/gavi/PQ_Web/ www.who.int/immunization/news_guidance_ impact/our-impact/facts-and-figures PreviewVaccine.aspx?nav=0&ID=249 immunization_services_during_COVID-19/en/

17. Gavi, the Vaccine Alliance, ‘ 35. The International Federation of Pharmaceutical Support’, accessed April 2020, https://www.gavi.org/ Manufacturers & Associations, ‘Innovation for a types-support/vaccine-support/rotavirus Healthier World: Halting Cervical Cancer’, accessed April 2020 https://www.ifpma.org/wp-content/ 18. Atherly DE, Lewis KDC, Tate J, Parashar UD, uploads/2016/02/IFPMA_Vaccine_Healthier_World_ Rheingans, RD. Projected health and economic impact verF.pdf of rotavirus vaccination in GAVI-eligible countries: 2011-2030. Vaccine. 2012;30(Suppl 1):A7–A14) 36. The International Federation of Pharmaceutical Manufacturers & Associations, ‘Global Health Progress: Gavi, the Vaccine Alliance: GSK’, accessed April 2020 https://globalhealthprogress.org/ collaboration/gavi-the-vaccine-alliance/

30 About IFPMA The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) represents research-based pharmaceutical companies and associations across the globe. Research-based pharmaceutical companies make a unique contribution to global health as innovators of lifesaving and life-changing medicines and vaccines, which improved millions of lives around the world. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health. Global Health Progress IFPMA hosts Global Health Progress, an interactive knowledge hub highlighting over 250 collaborations between the innovative biopharmaceutical industry and more than 1200 partners to support the Sustainable Development Goals (SDGs). Users can explore collaborations by SDG target, disease area, program strategy, and more. Our cross-sector partnerships are continually learning from each other, and through our deep and trusted collaborations we share insights and best practices from our experiences. Check out Global Health Progress www.globalhealthprogress.org.

@IFPMA ifpma.org @GlobalHealth IFPMA

About ABPI The ABPI exists to make the UK the best place in the world to research, develop and use new medicines. We represent companies of all sizes who invest in discovering the medicines of the future. Our members supply cutting edge treatments that improve and save the lives of millions of people. We work in partnership with Government and the NHS so patients can get new treatments faster and the NHS can plan how much it spends on medicines. Every day, we partner with organisations in the life sciences community and beyond to transform lives across the UK.

abpi.org.uk @ABPI_UK ABPI

The International Federation of Pharmaceutical Manufacturers & Associations. May 2020.