Global Immunization News (GIN) March 2015

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News World Immunization Week 2015: Close the immunization gap -  Vacc Week in the Americas 2015: 2 Boost Your Power! Get Vaccinated! vaccination for all  Colombia becomes the second country 3 Hayatee Hasan, WHO Headquarters in the Americas to have an accredited lab for quality control of syringes The World Immunization Week (WIW), which will  WHO/Europe supports Kazakhstan in 3 response to adverse events mistakenly be held from 24-30 April 2015, will signal a renewed

linked to measles immunization global, regional, and national effort to accelerate ac-

 Myanmar launches its largest ever vac- 4 tion to increase awareness and demand for immuniza-

cination campaign, reaching 17.4 million tion by communities, and improve vaccination delivery

children with MR Vaccine services. This year’s campaign focuses on closing the  Kyrgyzstan initiates mass vacc campaign 4 as measles cases continue to soar immunization gap and reaching equity in immunization levels as outlined in the Global Vaccine Action Plan,  National stakeholders and international 5 experts team up to tackle measles and which is a framework to prevent millions of deaths by rubella in Italy 2020 through universal access to vaccines for people  Bangladesh introduces two new vac- 5 in all communities. Read more about this year’s cam- cines paign.  Vaccination must be scaled up in Ebola- 6 affected countries The WIW 2015  Ebola vaccine efficacy trial ready to 6 launch in Guinea campaign website is now available in Arabic, Chinese,  PAHO Immunization unit’s Measles 7 English, French, Russian and Spanish. experts interviewed on Univision The campaign poster in 6 languages can be download- Obituary 7 ed from the website. An infographic, animated video Upcoming meeting 8 and web banner to be Past meetings / workshops included in email signa-  Training WS on cMYP for immunization 9 tures are also in the  Annual meeting of the Nat EPI manag- 10 works and will be ers for AFRO Central ready very soon.  Informal consultation on regulatory 11 considerations for evaluation of Ebola

vaccines intended for emergency use A social media package  Global Vaccine Safety Study: Training 12 with suggested Tweets Workshop on Study Procedures for as well as photos and stories to share on Facebook and PAHO Countries Instagram will be developed. The official hashtag for this 12- Resources year’s campaign is #vaccineswork. 15 18- Calendar 19

Links 20

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Global Immunization News (GIN) March 2015

Vaccination Week in the Americas 2015: Boost Your Power! Get Vaccinated! Octavia Silva; Alba Maria Ropero; Hannah Kurtis; Elizabeth Thrush; PAHO-Washington, DC

Regional Communication Campaign Vaccination Week in the Americas is almost here! The 13th annual celebration of PAHO’s Vaccination Week in the Americas regional vaccination campaign begins 25 April and ends 2 May 2015. This year’s regional slogan is “Boost your power! Get vaccinated!” and is inspired by the idea that vaccination boosts immune systems and helps the body defeat more than 20 preventable diseases, turning those who get vaccinated into superheroes with special powers to defeat illness. Regional communication campaign materials include posters, stickers, and banners in English, Spanish, Portuguese, French and Creole. PAHO has also partnered with the Chespirito Foundation to create materials that feature the image of the Cha- pulín Colorado, a popular Latin American cartoon. A video message from PAHO’s director will be uploaded soon to the webpage.

The social media component will encourage people to pair the hashtags #GetVax and #BoostYourPower with online photos of themselves posing as superheroes and holding #GetVax signs. Individuals are also encouraged to post photos on social media or upload them to the PAHO website.

Regional Launching Event The regional VWA launching event will take place on 25 April 2015 in Duran, Ecuador, an indigenous community outside of Guayaquil. Countries are continuing to submit plans for the initiative, and to date, countries and territories have reported plans to vaccinate more than 56 million individuals through a wide variety of campaigns. More detailed information on country activities will be included in the April GIN.

Regional Launching Event The regional VWA launching event will take place on 25 April 2015 in Duran, Ecuador, an indigenous community outside of Guayaquil. Countries are continuing to submit plans for the initiative, and to date, countries and territories have reported plans to vaccinate more than 56 million individuals through a wide variety of campaigns. More detailed information on country activities will be included in the April GIN.

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Global Immunization News (GIN) March 2015

Colombia becomes the second country in the Americas to have an accredited laboratory for the quality control of syringes used for its immunization programme Nora Lucia Rodriguez, PAHO-Washington, DC

On 12 February 2015, the Pan American Health Organization (PAHO) recognized INVIMA (Instituto Nacional de Medicamentos y Alimentos/National Food and Drug Surveillance Institute) for having its laboratory accredited for carrying out the required tests to confirm the quality control of syringes used for vac- cinations in Latin America and the Caribbean. The Colombian agency is responsible for the health and regulatory surveillance of products and services for its citizens. Representatives from PAHO and INVIMA at the INVIMA recognition Following an assessment that supported that the laboratory of INVIMA met the ceremony on 12 February in Colom- International Standards NTC ISO / IEC 17025: 2005, the laboratory received its bia. accreditation which was awarded by the National Accreditation Agency of Co- lombia - ONAC to perform physical-mechanical tests for syringes and needles.

The recognition was given during the 20th anniversary of INVIMA, where the representative of PAHO/ WHO in Co- lombia, Dr Gina Watson, and PAHO Regional Advisor in Washington, DC Bact. Nora Lucia Rodriguez, congratulated the Institute for this achievement.

PAHO considers the quality, safety and effectiveness of syringes used for vaccination of public health importance. Since 2005, the PAHO Immunization Unit (FGL/IM) has had a quality control programme for syringes used in vaccination in national immunization programmes, particularly those syringes purchased through the PAHO Revolving Fund for vaccine procurement. In support of the accreditation process, PAHO’s Immunization Unit also provided training and other resources to INVIMA, as well as to other countries that form the regional network for the quality control of syringes used in immunization programmes. WHO/Europe supports Kazakhstan in response to adverse events mistakenly linked to measles immunization Katrine Habersaat, WHO EURO

Kazakhstan initiated a measles vaccination campaign targeting one million adolescents in February 2015 in response to a large measles outbreak that began in 2014. During the campaign, a series of adverse events was mistakenly linked with the vaccine, causing concern about the vaccine's safety and resulting in temporary suspension of immunization activities. At the request of the Ministry of Health, WHO/Europe worked with the Kazakhstan health authorities to initiate an immediate investigation and communication response.

Investigators soon learned that the tragedy of a 15-year old girl dying four days WHO and vaccine safety experts ad- following vaccination was caused by meningitis and was not related to the vac- dress 30 journalists in roundtable cine. In a separate event, 83 adolescents became faint, dizzy, weak in their arms briefing to increase knowledge and and legs and agitated following the vaccination. This was determined to be understanding of the risks of measles caused by anxiety and fear of the injection, not the vaccine itself, and is a well- and the safety and effectiveness of the known phenomenon that occurs occasionally among adolescents following vaccine, Astana. Credit: WHO immunization.

Based on the preliminary conclusions of the investigation, an intensive effort is being put into re-establishing trust among the public and the media.

"Increasing awareness about measles and the vaccine's excellent safety profile among parents, journalists, health authorities, spokespersons and key opinion leaders in the medical community is essential" said Robb Butler, one of the WHO experts supporting the Government's response. Careful planning and outreach will therefore be necessary before the campaign can be resumed. More information on adverse events following immunization (AEFIs) Page 3

Global Immunization News (GIN) March 2015

Myanmar launches its largest ever vaccination campaign, reaching 17.4 million children with Measles Rubella (MR) Vaccine Vinod Bura, WHO Myanmar

The government of Myanmar is committed to achieving the WHO South East Asia Regional goal of measles elimination and rubella control by 2020. Under the leadership of the Ministry of Health, with support from WHO, GAVI and UNICEF, Myanmar conducted a nationwide Measles Rubella Vaccine campaign in two phases in January-February 2015, targeting approx. 17.4 million children in the age group of nine months to 15 years.

The first phase targeted children age five to 15 years in all schools which in- A school girl being vaccinated with cluded government, private and monastic schools. The second phase targeting Measles Rubella vaccine. Credit: Min- approx. 65,000 villages / urban wards was conducted in February 2015, vac- istry of Health, Myanmar cinating children from nine months to five years of age, plus children missed in the school phase and children who do not attend school. Preparatory activities were undertaken such as the establishment of a Central Executive Committee, and the development of planning guidelines and technical training guidelines for health workers, school teachers, and volunteers. Village/ward-wise micro plans and master lists of eligible children were completed, and local advocacy meetings were held. Extensive social mobilization was carried out in communities using TV/Radio, displaying posters, banners, stickers and distribution of invita- tion cards to all families. Health workers were re-trained with special emphasis on injection safety practices, and prevention and management of adverse events following immunization. The cold chain, vaccine, and supply chain sys- MR Vaccine being transported in hard tems were strengthened. WHO deployed six technical experts to support the to reach areas by Military Helicopters preparations. in Kachin State

The campaign reached approximately 94% of the target population. Even in areas of conflict and inter-communal tensions, the unprecedented mobilization of health staff, volunteers and community leaders helped coverage to reach levels comparable to the national average. The success of the MR campaign is attributed to high level of political commitment, high quality preparedness supported by WHO and UNICEF, dedicated health staff, and strong support from the Ministry of Education, local authorities and volunteers. Starting in May 2015, MR vaccine will be part of the national routine immunization programme. Kyrgyzstan initiates mass vaccination campaign as measles cases continue to soar Catharina de Kat-Reynen, WHO EURO

In response to a large-scale measles outbreak, Kyrgyzstan started a mass measles vaccination campaign on 16 March 2015, targeting over two million people aged one to 20 years. The outbreak, which began in early 2014, has caused over 11 300 suspected cases to date and continues to increase by 120–250 suspected cases every day.

The first phase of the campaign focuses on seven to 20-year-olds in the capital city of Bishkek and in Chui Oblast, which are the age group and areas most affected. The second phase, planned for April–May 2015, will target children under seven years of age in these areas, and children and adolescents up to 20 years of age in the rest of Kyrgyzstan.

After a dramatic increase in daily reported cases in November 2014, the Measles and Rubella Initiative Outbreak Response Fund provided US$ 500 000 for the outbreak response and other emergency needs in Kyrgyzstan. The funds were provided through WHO/Europe to cover the operational costs of the supplementary immunization activities. Another US$ 1.9 million were provided for the bundled vaccine for measles and rubella and US$ 250 000 for communication and social mobilization activities for the outbreak response through the United Nations Children's Fund (UNICEF).

WHO and UNICEF have been providing communication and logistics support to the Government in preparation for the campaign. National spokespersons have been trained by WHO to communicate effectively with the media, and Page 4 health care workers have received training on how to vaccinate correctly and safely.

Global Immunization News (GIN) March 2015

National stakeholders and international experts team up to tackle measles and rubella in Italy Catharina de Kat-Reynen, WHO EURO

To help Italy accelerate progress towards the elimination of measles and rubella, a del- egation of WHO experts and other stakeholders visited the country on 10-11 March 2015.

All 53 Member States of the WHO European Region committed in 2010 to eliminate measles and rubella by the end of 2015. Italy is among the countries in the Region that have not yet interrupted endemic transmission of these diseases. Among indicators of concern is the high number of measles cases reported by Italy for 2014 WHO/Europe-led team visits a (preliminary data indicate over 1500 cases). vaccination clinic in Rome, 10 March 2015. Credit: WHO The team focused on the process of achieving and documenting interruption of endemic transmission, including the need for high-quality surveillance and immunization coverage data and the roles and responsibilities of the various parties involved.

Hosted by the Director General of Health Prevention of the Ministry of Health, the mission team met with representatives of key ministries and partners, including the National Institute of Health, scientific and civil societies, the National Health Council and the Italian National Verification Committee for measles and rubella elimination.

At one of the largest vaccination centres in Rome, the team met with frontline health workers and learned more about the challenges and strengths of the health system. Finally, the mission provided an opportunity for the Ministry to strengthen relations with Lions Club International, a civil society organization present in all 21 regions of Italy, and an important resource ready to provide support towards eliminating these diseases.

WHO/Europe measles experts were accompanied by representatives of the Regional Verification Commission for measles and rubella elimination, the Measles and Rubella Initiative, the Sabin Institute, the European Technical Adviso- ry Group of Experts on Immunization and Lions Clubs International. WHO/Europe will present the team’s conclusions and recommendations to the Ministry and continue working with the Italian authorities to address obstacles to elimination.

Bangladesh introduces two new vaccines Hayatee Hasan, WHO Headquarters

The inactivated polio vaccine (IPV) and the pneumococcal conjugate vaccine (PCV) was introduced in Bangladesh at a dual launch in Dhaka on 21 March 2015. The dual introduction was made possible through the collaboration of the Government of Bangladesh with WHO, UNICEF and Gavi, the Vaccine Alliance.

PCV will benefit more than 3 million children, and the introduction of IPV is a crucial part of objective 2 of the Polio Eradication and Endgame Strategic Plan. Baby receiving PCV vaccine. Credit: UNICEF/A. Hasman “With high immunization coverage in Bangladesh, this introduction of two more vaccines, PCV and IPV, is a step in the right direction. The inclusion of IPV in routine immunization in Bangladesh would help maintain Bangladesh’s polio-free status and the introduction of cost-effective PCV would bring significant reduction in childhood diseases and deaths. We are confi- dent that the introduction and uptake will continue to remain high. WHO continues to support the Bangladesh’s EPI programme,” said Dr N. Paranietharan, WHO Representative to Bangladesh. Read the news release More on objective 2 of the Polio Endgame Plan

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Global Immunization News (GIN) March 2015

Vaccination must be scaled up in Ebola-affected countries Hayatee Hasan, WHO Headquarters

A growing risk of outbreaks of measles, pertussis, and other vaccine- preventable diseases in countries affected by Ebola must be countered by urgent scaling up of routine immunization activities. The Ebola outbreak, which has infected some 24 000 people and killed around 10 000 of them, has reduced vaccination coverage in Guinea, Liberia and Sierra Leone, as health facilities and staff focus on halting the outbreak.

“We are calling for the intensification of routine immunization services in all areas, and for mass measles vaccination campaigns in areas that Credit: WHO/P. Desloovere are free of Ebola transmission,” says Dr Jean-Marie Okwo-Bele, Direc- tor of Immunization, Vaccines and Biologicals at WHO.

The Ebola outbreak, which has infected some 24,000 people and killed around 10,000 of them, has also reduced vaccination coverage in Guinea, Liberia and Sierra Leone, as health facilities and staff focus on halting the outbreak.

“Any disruption of immunization services, even for short periods, will result in an increase in the number of susceptible individuals, and will increase the likelihood of vaccine-preventable disease outbreaks,” according to a WHO note sent to countries this week. The new guidance for immunization programmes in the African Region in the context of Ebola to help countries maintain or restart immunization services includes infection control pre- cautions for health workers. The document notes that for countries not affected by Ebola, routine immunization and surveillance “should continue using the normal safe injection and waste disposal practices.” Read the news release on immunization services in Ebola-affected countries

Ebola vaccine efficacy trial ready to launch in Guinea Hayatee Hasan, WHO Headquarters

Based on promising data from initial clinical trials in late 2014, WHO with the Health Ministry of Guinea, Médecins Sans Frontières (MSF), Epi- centre and The Norwegian Institute of Public Health (NIPH), will launch a Phase III trial in Guinea on 7 March to test the VSV-EBOV vaccine for efficacy and effectiveness to prevent Ebola.

“We have worked hard to reach this point,” said WHO Director- General, Dr Margaret Chan. “There has been massive mobilization on the part of the affected countries and all partners to accelerate the development and availability of proven interventions. If a vaccine is found WHO Director-General, Dr Margaret effective, it will be the first preventive tool against Ebola in history.” Chan

Vaccination will take place in areas of Basse Guinée, the region that currently has the highest number of cases in the country. The trial strategy adopted will be “ring vaccination”, based on the approach used to eradicate small- pox in the 1970s. This involves the identification of a newly diagnosed Ebola case – the “index case” – and the tracing of all his/her contacts. The contacts are vaccinated if they give their consent.

The vaccine was developed by the Public Health Agency of Canada. A second vaccine will be tested in a sequential study, as supply becomes available. More on the Ebola vaccine trial in Guinea Q&A on Ebola Phase III vaccine trial in Guinea

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Global Immunization News (GIN) March 2015

PAHO Immunization unit’s Measles experts interviewed on Univision Octavia Silva, PAHO-Washington, DC

Dr Cuauhtémoc Ruiz Matus, chief of the Comprehensive Family Immunization Unit, along with Dr Desiree Pastor, regional advisor on measles and rubella, were interviewed by the television channel Univision to discuss measles, a matter that has recently received significant media attention. This media attention is mainly due to the recent outbreaks that have affected the Region, particularly an outbreak that was linked to the Disneyland theme park in Califor- nia. The interview was televised as a segment on Univision’s nighttime news on 15 February 2015. The highly conta- gious nature of the virus and the erroneous connection between the measles vaccine and autism, a fear that has con- tributed to many people not getting vaccinated and becoming susceptible to measles, were among the topics dis- cussed. To see the video (in Spanish), please click on this link. Obituary

Andrew William Garnett 1943-2015. Died 22 February 2015 by Anthony Battersby

Andrew was born and brought up in England. He graduated as an architect in 1969, went on to earn a MDes(RCA) degree from the Department of Design Research, Royal College of Art, London and a BSc (first class), in Biological Sciences from Birkbeck College Lon- don. Between 1977 and 1979 he was chief architect to the Ministry of Health in Gongola State Nigeria, where he was responsible for developing the Central Medical Stores and other buildings for Basic Health Services.

He attended a WHO EPI briefing course in 1985 and began working as a consultant for WHO.

Between 1985 and 1996 Andrew undertook numerous in-country consultancies for WHO, UNICEF, JSI and Danida. Andrew was also joint editor and author of the distribution section of Managing Drug Supply (second edition).

He came to the attention of the wider EPI community in 2001 when he was rapporteur at the 8th TechNet conference in Delhi. He made enormous and important contributions particularly in the field of vaccine management and logistics. The achievement with which most people will be familiar is the WHO-UNICEF Effective Vaccine Management strategy, of which Andrew was one of the primary designers. In addition he made major contributions to the development of the Prequalification System (PQS), being responsible for writing many of its protocols.

He was diagnosed with Mesothelioma in September 2014. The effects of chemotherapy forced him to stop working.

For those of us who were fortunate to know him, the loss of Andrew leaves a huge gap. Not only will he be missed for his brilliant and clear mind, but also his good and gentle spirit.

He is survived by his wife Bonnie, daughter Tara, son Michael, Step-daughter Marigold, grandson Ezra, and grand- daughters Rachel and Kyla.

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Global Immunization News (GIN) March 2015 Upcoming Meeting Workshop on "National Immunization Programme and Vaccine Coverage in ASEAN countries" Usa Thisyakorn, Pediatric Infectious Disease Society of Thailand Location: Pattaya, Thailand Date: 30 April 2015 Participants: Twenty participants (including the Presidents and key opinion leaders in Pediatric Infectious Disease Societies), representing 10 countries from ASEAN (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam). Purpose: General: To promote sharing of knowledge and collaboration among the ASEAN countries in the prevention and control of pediatric infectious diseases. Specific objectives: 1. To share an update on the global situation and key interventions on vaccination. 2. To share updates on immunization programmes and the vaccine coverage in each ASEAN country. 3. To support and encourage quality research in pediatric infectious diseases in ASEAN countries. 4. To promote collaboration among the Pediatric Infectious Disease Society and experts in the Re- gion. Details: The workshop sessions will include: - A keynote speech entitled “Vaccination for all ages” (Dr Jean-Marie Okwo-Bele, The World Health Organization). - A workshop session inviting the President of the Pediatric Infectious Disease Society and the Pres- ident of the Pediatric Society from each country to present on their national immunization programme. - A session on country reports from ASEAN countries for comment by experts in order to promote and encourage quality research.

The goal of the workshop is to exchange information on the national immunization programmes and the sharing of research results from countries in the Region. This will be useful for delegates attend- ing the workshop to share best practices, to support national programme planning, as well as to promote collaboration among countries. Quality research will be encouraged in countries of the Region. The outcomes of the workshop will be included in an article published in a peer-review journal, to guide policy makers, programme managers and scientists working in this field.

The ultimate goal of the workshop is to improve the health of children affected by infectious diseases, the fastest growing health burdens the world is facing.

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Global Immunization News (GIN) March 2015 Past Meetings/Workshops Training workshop on comprehensive multi-year planning (cMYP) for immunization Claudio Politi, WHO HQ; Michael Hinsch and Nikhil Mandalia, WHO consultants Location: Geneva, Switzerland Date: 16-20 February, 2015 Participants: Thirty-five (35) international consultants, WHO staff and representatives from partner institutions Gavi, UNICEF, Centre for Disease Control (CDC), Sabin Vaccine Insti- tute, the Clinton Health Access Initiative (CHAI), and Agence de Médecine Préventive (AMP). Purpose: The objectives of the workshop were as follows: To update consultants, immunization partners and WHO staff on the development of cMYPs and Annual Immun- ization Workplans, using the recently revised cMYP guidelines and tools. To share experiences and best practices developed over recent years in supporting countries with developing cMYPs and Annual Workplans. To establish a core group of experts who can provide technical support to regional and country efforts in the development and updating of cMYPs and Annual Immun- ization Workplans.

Details: The cMYP is a strategic planning document for immunization services which provides comprehensive strategies based on country-specific needs. It integrates costing and financing analysis to en- sure immunization financial sustainability. In 2015, approximately 40 countries are expected to develop or update their cMYPs.

The workshop looked to equip participants with knowledge and understanding of the recently revised cMYP guidelines and procedures, issued in 2014, and in doing so create a core group of technical experts for the provision of country and regional support.

The agenda included presentations on immunization costing and financing, health systems and equity, development of national priorities, as well as supply chain logistics and forecasting. In addition, working group sessions on the cMYP costing tool as well as plenary discussions on country experiences and lessons learned were organized to facilitate sharing of best practice.

Following this training workshop, it is expected that a number of participants will be deployed to provide technical assistance to countries, or to support regional workshops for national EPI staff who will undertake comprehensive immunization planning.

For more information on cMYP guidelines and tools, click on this link.

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Global Immunization News (GIN) March 2015

Annual meeting of the National Expanded Programme on Immunization managers for AFRO Central Auguste Ambendet, WHO/IST central Location: Douala, Cameroon Date: 23-26 February 2015 Participants: EPI managers, surveillance managers, IVE focal points from WHO and UNICEF, from Angola, Burundi, Ca- meroon, the Central African Repu- blic, Chad, Congo, DRC, Equatorial Guinea, Gabon, and Sao Tome and Principe. Partners from Agence de Médecine Préventive, Association Internationale des gérants de la Vac- cination (IAIM) du Plan Cameroun, BMGF, US-CDC, Gavi, Médecins sans frontières, Organisation pour la Coordination pour la lutte contre les Endémies en Afrique centrale (OCEAC), PATH, Sabin Vaccine Insti- Group photo at the opening of the workshop tute and the president of the Natio- nal Committee for Polio Certification

Purpose: To exchange information on progress made in 2014 and obtain consensus on priority activities for 2015 to reduce morbidity and mortality due to vaccine-preventable diseases. A one-day session was held to familiarize participants on the tOPV to bOPV switch, an activity that is to be synchronized world-wide in April 2016.

Details: The meeting was organized in five sessions around the following themes : immunization systems strengthening ; the Global Polio Eradication initiative (GPEI) ; accelerated immunization initiatives (maternal and neonatal tetanus, measles, meningitis and yellow fever) ; improving data quality ; and country updates.

Presentations were reduced to their minimum to focus on discussions identifying bottlenecks and finding suitable solutions. Discussions focused on: the reasons behind stagnating and decli- ning routine immunization coverages; challenges to countries to increase coverage in a sustainable and equitable way; reasons for limited data reporting by countries; vulnerability of countries to the importation of the wild polio virus, despite the many organized supplementary immunization activities (SIAs); reasons for recurring measles outbreaks in the sub-region despite many SIAs; persistant yellow fever outbreaks; and reasons for deaths due to neonatal tetanus, despite the availability of efficient vaccines.

Gavi organized a special session on new developments in their policies, and smaller sub- meetings were organized daily with delegations from various countries. Action points, rather than recommendations, were drafted by countries themselves and will be integrated into each country’s action plan. WHO AFRO IST/Central has compiled these action points into a table for easy follow-up.

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Global Immunization News (GIN) March 2015

Informal consultation on regulatory considerations for evaluation of Ebola vaccines intended for emergency use

Ivana Knezevic, David Wood and Tiequn Zhou, WHO Headquarters

Location: Geneva, Switzerland

Date: 18-19 March 2015 Participants: Regulators from Canada, China, Germany, Kenya, Sierra Leone, South Africa, Switzerland, Tanzania, Thailand, Uganda, United Kingdom, United States; manufacturers and developers of Ebola vaccines.

Purpose: In response to requests from countries affected by the current Ebola epidemic, World Health Organi- zation (WHO) has been working with National Regulatory Authorities (NRAs) on approaches to facilitate vaccine development for use in emergency settings. A WHO consultation was organized to discuss regulatory and manufacturers’ perspectives on evaluating candidate Ebola vaccines in order to reach consensus on the key issues to be addressed in the following draft documents: 1) Scientific and regulatory considerations for the evaluation of vaccines intended for use in public health emergencies 2) Draft - Guidelines on the quality, safety and efficacy of Ebola vaccines

Details: Main outcomes: Document 1: Should differentiate between a regulatory pathway to facilitate access to products for use in a public health emergency from the full licensure of a vaccine. In a public health emergency, regulatory decisions will need to be made on risk-benefit ratio at a given time point, before the full data set for licensure becomes available.

Document 2: Should identify flexibilities in the quality, non-clinical and clinical evaluation of Ebola vaccines to accelerate clinical development in comparison to data required for full licensure. Among numerous challenges, lack of scientific evidence for correlate of protection is a major issue.

WHO’s role in facilitating discussion and information-sharing between regulators from affected countries with more experienced NRAs was recognized.

As part of the regulatory preparedness strategy, consideration should be given to how ongoing clinical trials during the current outbreak/epidemic can inform strategy for future outbreaks.

Further revision of the documents and a public consultation will take place in the coming months and progress will be reported to the WHO Expert Committee on Biological Standardization (ECBS) and SAGE.

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Global Immunization News (GIN) March 2015

Global Vaccine Safety Study: Training Workshop on Study Procedures for PAHO Countries Helvert Felipe Molina León, PAHO-Washington, DC; Pamela Bravo Alcántara, PAHO-Washington, DC; Jose Luis Castro, PAHO-Washington, DC Location: Santiago, Chile Date: 4-5 March 2015 Participants: Principal investigators from participating hospitals and representatives from the National Reg- ulatory Authorities, Expanded Programme on Immunization (EPI) and Ministries of Health. A total of 30 participants from Argentina, Chile, Colombia, Costa Rica, Honduras, Peru and Uru- guay. Purpose: To train a group of researchers on the study procedures required to guarantee a standard high quality data collection process throughout the Region of the Americas. Details: Vaccine safety experts from the methodological committee of the study, along with the Pan- American Health Organization (PAHO) coordination group, explained the details of the data collection process to the researchers, from identifying retrospective cases identification to generating a transfer file for analysis.

A challenge faced by the Region is to guarantee a standard implementation process that gath- ers high quality data, free from the bias that can affect the association between a vaccine and an adverse event. The workshop aimed to facilitate this by teaching the critical issues faced during the data validation process such as, how to select probable cases, registering exclusion criteria, blinding the retrieval of information from exposure, adequately reviewing clinical charts and selecting the source of requested data, among others.

Participants had the opportunity to practice all processes on dummy cases, as well as learn how to use the electronic tools for data collection.

Facilitators from the coordination group could learn details of each site and consider how the study implementation should be adapted to the particularities and variety of countries in the AMRO region.

At the end of the workshop and thanks to participant feedback, it was determined that some processes were proven to be consistently applied while others had to be refined. Throughout the meeting, a sense of collaborative work was shared. Resources Innovation for a Healthier Future – How the research-based vaccine manufacturers are contributing to the Decade of Vaccines Global Vaccine Action Plan Laetitia Bigger, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently released its report on vaccine innovation across the value chain, Innovation for a Healthier Future – How the research-based vaccine manufacturers are contributing to the Decade of Vaccines Global Vaccine Action Plan (2015). The world counts on an array of stakeholders to fully achieve disease elimination and vaccination coverage targets, develop and intro- duce new and improved vaccines and technologies, and reduce child mortality. This report shows how research- based manufacturers are innovating beyond the traditional research and development model by working with partners to optimize production to meet growing demand, improving the supply chain to reach people in remote areas, and supporting strong national commitment to immunization.

To download the report and infographic available in English – please visit this website.

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Global Immunization News (GIN) March 2015

Summary Tables of WHO Routine Immunization Recommendations Tracey Goodman, WHO Headquarters

The tables have been updated to reflect the newly published WHO recommendations for:

1. Meningococcal A conjugate vaccine: Updated guidance (now for routine infant vaccination) 2. Japanese Encephalitis vaccines: WHO Position paper

The latest versions (February 27, 2015) of the Summary Ta- bles available in both FRENCH and ENGLISH can be downloaded from the WHO website. As these tables are updated periodically, it is always best to refer to the website for the most recent version.

A User's Guide to the Summary Tables can be found at this link. This short guide has been developed as a companion piece to help orientate users of the summary tables.

What are the purposes of this guide? • To raise awareness that the full spectrum of WHO recommendations for routine immunization are available in two summary tables. • To explain how the summary tables can be used at country level to review and possibly modify a national immunization schedule so that it has greater impact and efficiency. • To highlight practical and operational issues that country decision-makers should consider when making a change to the national immunization schedule.

The Summary Tables are intended for use by national immunization managers and key decision-makers, chairs of national advisory committees on immunization, and partner organizations, including industry.

Guidelines for enterovirus surveillance in support of the polio eradication initiative

The strategy for achieving polio eradication and maintaining polio-free status until global certification of eradication is complete has two major components: establishing high population immunity to polioviruses through immunization, and detecting and rapidly responding to poliovirus cases through high- sensitivity surveillance. While surveillance for acute flaccid paralysis is considered the "gold standard" for countries that were endemic or recently endemic for poliovirus, other surveillance strategies and data have been accepted from countries with a long history of non- endemicity, high levels of sanitation and strong health system.

These guidelines, devised by the WHO Regional Office for Europe and the United States Centers for Disease Control and Prevention (CDC), provide national decision-makers and their technical advisors with information on the principles and practices of adopting enterovirus surveillance to support the Polio Eradication Initiative. The guidelines will help them de- cide if an enterovirus surveillance system could be established, or existing systems modified, that would meet both disease-control and programmatic requirements.

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Global Immunization News (GIN) March 2015

PAHO/WHO IPV Training Modules and Communication Documents Elizabeth Thrush, PAHO-Washington, DC

This year, on a global scale, over 100 countries that previously only used the oral polio vaccine (OPV) containing the live attenuated poliovirus are introducing the inactivated poliovirus vaccine (IPV) into their routine immunization programmes. OPV will gradually be withdrawn from all immunizations programmes, starting with the type 2 component of the trivalent vaccine (tOPV). IPV is needed in every country to maintain immunity against poliovirus type 2 after the switch from tOPV to bOPV (containing types 1 and 3), which is tentatively scheduled to occur in April 2016.

To support regions and countries with the introduction of IPV, the communications sub-group of the Immuniza- tion Systems Management Group (IMG)/ Global Polio Eradication Initiative (GPEI) developed training modules for health care workers, as well as technical documents and communication materials for planning at the national and local levels.

The Pan American Health Organization/World Health Organi- zation (PAHO/WHO) adapted and expanded these training modules and three of the communication documents to support the countries of the Americas with IPV introduction.

The modules cover important topics related to IPV introduction such as rational for introduction, storage requirements, eligibility, administration, record- ing, monitoring events supposedly attributable to vaccination or immunization (ESAVIs), and communicating with parents and caregivers, and other important topics. The three communication documents cover issues related to safety and acceptability of multiple injections, preparing for unexpected situations, and a media kit for drafting local messages and designing communication plans and strategies around the introduction of IPV.

The PAHO/WHO adapted training modules and communication documents are available in Spanish, English and French and may be downloaded at the PAHO polio webpage.

Note: Original IMG materials may be found at the WHO IPV Introduction web page.

WHO issues its first hepatitis B treatment guidelines Hayatee Hasan, WHO Headquarters

WHO issued its first-ever guidance for the treatment of chronic hepatitis B, a viral infection which is spread through blood and body fluids, attacking the liver and resulting in an esti- mated 650 000 deaths each year. Worldwide, some 240 million people have chronic hepatitis B virus and are at increased risk of dying from cir- rhosis and liver cancer.

WHO recommends that all children are vaccinated against hepatitis B, with a first dose given at birth. Effective medicines exist that can prevent people developing these conditions so they live longer.

Credit: WHO/G. Hampton Read the press release

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Global Immunization News (GIN) March 2015

New look for the NITAG Resource Center Alex Adjagba, Alice Henry-Tessier, Camille Morlière, Agence de Médecine Préventive (AMP)

The website for the NITAG Resource Center Health Policy and Institutional Development unit, which is a WHO Collaborating Center for evidence- informed immunization policy-making, has been revamped.

The site, which was created in 2010, aims to provide information, tools and training materials for National Immunization Technical Advisory Groups (NITAGs) and the international immunization community as a way of improving evidence-based decision-making at national level. The site has been completely redesigned and restructured to make it as practical and user-friendly as possible in an effort to meet the stated objective of all partners: to make it the sole plat- form for collaboration between NITAGs.

Technological innovations for easier searching

The new site features a streamlined and intuitive multi-criteria search engine to give more accurate searching of the document database, which includes (amongst other things) the recommendations from all existing NITAGs, reference documents and generic tools developed by all partners. The site has also been revamped to adapt automatically to the screen width on any device – PCs, tablets and smartphones – the goal being, once more, to improve readability.

A dedicated space for easy collaboration

There are several new sections on the site covering latest events, news and topics subject to review by the NITAGs and worldwide technical partners in the coming years, the goal being to promote knowledge-sharing in the global NITAG and wider international immunization community.

Last but not least, the biggest innovation on the new site is an interactive world map that shows the status of NITAGs. Users can now have immediate access to the operating indicators defined by WHO for each NITAG. In addition, clicking on a particular country opens a country fact sheet that gives more information on the relevant NITAG.

NITAG Resource Center homepage

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Global Immunization News (GIN) March 2015

2015 AprilCalendar 2-3 AFRO East and South Annual Progress Report (APR) workshop Pretoria, South Africa 14-16 Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization Geneva, Switzerland 14-16 GAVI Regional Working Group meeting for AFRO East and South Malawi 20-25 European Immunization Week EURO 27-29 21st EMRO Gavi Regional Working Group Djibouti May 4-5 Gavi Programme & Policy Committee Geneva, Switzerland 11-13 Gavi High Level Review Panel (HLRP) Geneva, Switzerland 11-15 2015 Technet Consultation TBD, Thailand 18-26 68th World Health Assembly Geneva, Switzerland

30-2May 9th International Conference on Typhoid and other invasive salmonellosis Bali, Indonesia June 9-12 WPRO Twenty-Fourth Meeting of the Technical Advisory Manila, Philippines Group on Immunization and Vaccine-Preventable Diseases (TAG) 10-11 Gavi Alliance Board Meeting Geneva, Switzerland 15-19 SEARO Technical Advisory Group Meeting New Delhi, India (?) 23-25 Protect-Innovate-Accelerate (PIA) Meeting Sitges, Spain 29-1 AFRO Task Force on Immunization (TFI) Addis Ababa, Ethiopia 29-2 Global Measles and Rubella Laboratory Network Meeting Geneva, Switzerland July 13-17 PAHO Technical Advisory Group Meeting TBC 20-24 Gavi High Level Review Panel (HLRP) Geneva, Switzerland September 1-2 EURO VPI Programme Managers’ Meeting Antwerp, Belgium 3-4 EURO Polio EPI and Lab Managers’ Meeting Antwerp, Belgium 30-2 Oct European Technical Advisory Group of Experts on Immunization (ETAGE) Copenhagen, Denmark

October 7-8 Gavi Programme and Policy Committee Geneva, Switzerland 14-15 Immunization Practices Advisory Committee (IPAC) meeting Geneva, Switzerland 14-16 Gavi High Lever Review Panel (HLRP) Geneva, Switzerland 20-22 Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization Geneva, Switzerland November 6-20 Gavi Independent Review Committee (IRC) for new proposals Geneva, Switzerland December 2-3 Gavi Board Meeting Geneva, Switzerland Page 16

Global Immunization News (GIN) March 2015 Links

Organizations and Initiatives

American Red Cross Sabin Vaccine Institute Child Survival Sustainable Immunization Financing

Agence de Médecine Préventive UNICEF Africhol Immunization EpiVacPlus Supplies and Logistics LOGIVAC Project SIVAC USAID Maternal and Child Health Integrated Program Centers for Disease Control and Prevention Polio WHO Global Vaccines and Immunization Department of Immunization, Vaccines & Biologicals New and Under-utilized Vaccines Implementation Johns Hopkins ICO Information Centre on HPV and Cancer International Vaccine Access Center Immunization financing Vaccine Information Management System Immunization service delivery Immunization surveillance, assessment and monitoring JSI SIGN Alliance Africa Routine Immunization Systems Essentials Project IMMUNIZATIONbasics Maternal and Child Health Integrated Program (MCHIP) Other Coalition Against Typhoid PAHO Dengue Vaccine Initiative ProVac Initiative European Vaccine Initiative Gardasil Access Program PATH Gavi the Vaccine Alliance Vaccine Resource Library International Association of Public Health Logisticians Rotavirus Vaccine Access and Delivery International Vaccine Institute Malaria Vaccine Initiative Measles & Rubella Initiative Meningitis Vaccine Project Multinational Influenza Seasonal Mortality Study RHO Cervical Cancer TechNet-21 Vaccines Today

WHO Regional Websites UNICEF Regional Websites Routine Immunization and New Vaccines (AFRO) Immunization (Central and Eastern Europe) Immunization (PAHO) Immunization (Eastern and Southern Africa) Vaccine-preventable diseases and immunization (EMRO) Immunization (South Asia) Vaccines and immunization (EURO) Immunization (West and Central Africa) Immunization (SEARO) Child survival (Middle East and Northern Africa) Immunization (WPRO) Health and nutrition (East Asia and Pacific) Health and nutrition (Americas)

Newsletters

Immunization Monthly update in the African Region (AFRO)

Immunization Newsletter (PAHO)

The Civil Society Dose (GAVI CSO Constituency)

TechNet Digest

RotaFlash (PATH)

Gavi Programme Bulletin (Gavi)

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