News In this issue

News

Vacc Week in the Americas 2015:

Boost Your Power! Get Vaccinated!

Colombia becomes the second country

in the Americas to have an accredited lab for quality control of syringes

WHO/Europe supports Kazakhstan in response to adverse events mistakenly

linked to measles immunization

Myanmar launches its largest ever vac-

cination campaign, reaching 17.4 million children with MR Vaccine

Kyrgyzstan initiates mass vacc campaign as measles cases continue to soar

National stakeholders and international experts team up to tackle measles and

rubella in Italy

Bangladesh introduces two new vac-cines

Vaccination must be scaled up in Ebola-affected countries

Ebola vaccine efficacy trial ready to launch in Guinea

PAHO Immunization unit’s Measles experts interviewed on Univision

2 3

3

4

4

5

5

6

6 7

Obituary 7

Upcoming meeting 8

Past meetings / workshops

Training WS on cMYP for immunization

Annual meeting of the Nat EPI manag-ers for AFRO Central

Informal consultation on regulatory

considerations for evaluation of Ebola vaccines intended for emergency use

Global Vaccine Safety Study: Training Workshop on Study Procedures for PAHO Countries

9

10

11

12

Resources 12-

15

Calendar 18-19

Links 20

Global Immunization News (GIN) March 2015

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World Immunization Week 2015: Close the immunization gap -

vaccination for all Hayatee Hasan, WHO Headquarters

The World Immunization Week (WIW), which will

be held from 24-30 April 2015, will signal a renewed

global, regional, and national effort to accelerate ac-

tion to increase awareness and demand for immuniza-

tion by communities, and improve vaccination delivery

services. This year’s campaign focuses on closing the

immunization gap and reaching equity in immunization

levels as outlined in the Global Vaccine Action Plan,

which is a framework to prevent millions of deaths by

2020 through universal access to vaccines for people

in all communities. Read more about this year’s cam-

paign.

The WIW 2015

campaign website is now available in Arabic, Chinese,

English, French, Russian and Spanish.

The campaign poster in 6 languages can be download-

ed from the website. An infographic, animated video

and web banner to be

included in email signa-

tures are also in the

works and will be

ready very soon.

A social media package

with suggested Tweets

as well as photos and stories to share on Facebook and

Instagram will be developed. The official hashtag for this

year’s campaign is #vaccineswork.

Page 2

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 initia-

tive, 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.

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 territo-

ries 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.

Global Immunization News (GIN) March 2015

Page 3

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) recog-

nized 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 respon-

sible for the health and regulatory surveillance of products and services for its

citizens.

Following an assessment that supported that the laboratory of INVIMA met the

International Standards NTC ISO / IEC 17025: 2005, the laboratory received its

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 vaccina-

tion 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 ado-

lescents 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

following vaccination was caused by meningitis and was not related to the vac-

cine. In a separate event, 83 adolescents became faint, dizzy, weak in their arms

and legs and agitated following the vaccination. This was determined to be

caused by anxiety and fear of the injection, not the vaccine itself, and is a well-

known phenomenon that occurs occasionally among adolescents following

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 au-

thorities, 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)

Representatives from PAHO and

INVIMA at the INVIMA recognition

ceremony on 12 February in Colom-

bia.

WHO and vaccine safety experts ad-

dress 30 journalists in roundtable

briefing to increase knowledge and

understanding of the risks of measles

and the safety and effectiveness of the

vaccine, Astana. Credit: WHO

Page 4

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-

cluded government, private and monastic schools. The second phase targeting

approx. 65,000 villages / urban wards was conducted in February 2015, vac-

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 meet-

ings 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-

tems were strengthened. WHO deployed six technical experts to support the

preparations.

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 activ-

ities. 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

health care workers have received training on how to vaccinate correctly and safely.

A school girl being vaccinated with

Measles Rubella vaccine. Credit: Min-

istry of Health, Myanmar

MR Vaccine being transported in hard

to reach areas by Military Helicopters

in Kachin State

Global Immunization News (GIN) March 2015

Page 5

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

(preliminary data indicate over 1500 cases).

The team focused on the process of achieving and documenting interruption of en-

demic 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 repre-

sentatives 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 conclu-

sions 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.

“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

WHO/Europe-led team visits a

vaccination clinic in Rome, 10

March 2015. Credit: WHO

Baby receiving PCV vaccine. Credit: UNICEF/A.

Hasman

Page 6

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 out-

break, 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

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 sus-

ceptible 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

Credit: WHO/P. Desloovere

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 de-

velopment and availability of proven interventions. If a vaccine is found

effective, it will be the first preventive tool against Ebola in history.”

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

WHO Director-General, Dr Margaret

Chan

Page 7

Global Immunization News (GIN) March 2015

Obituary

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 out-

breaks 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.

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 contri-

butions 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.

Page 8

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 pro-

gramme. - 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 pro-

mote 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 diseas-

es, the fastest growing health burdens the world is facing.

Global Immunization News (GIN) March 2015

Page 9

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 comprehen-

sive 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 addi-

tion, 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.

Global Immunization News (GIN) March 2015

Page 10

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-

tute and the president of the Natio-

nal Committee for Polio Certification

Group photo at the opening of the workshop

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 ses-

sion 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 sys-

tems 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 sustai-

nable and equitable way; reasons for limited data reporting by countries; vulnerability of coun-

tries to the importation of the wild polio virus, despite the many organized supplementary im-

munization 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.

Global Immunization News (GIN) March 2015

Page 11

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 facil-

itate vaccine development for use in emergency settings. A WHO consultation was organized to dis-

cuss 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, be-

fore the full data set for licensure becomes available. Document 2: Should identify flexibilities in the quality, non-clinical and clinical evaluation of Ebola vac-

cines to accelerate clinical development in comparison to data required for full licensure. Among nu-

merous 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 coun-

tries 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.

Global Immunization News (GIN) March 2015

Page 12

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 vac-

cine 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.

Global Immunization News (GIN) March 2015

Page 13

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 down-

loaded 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 immuniza-

tion 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 na-

tional 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 surveil-

lance 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 enterovi-

rus 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.

Global Immunization News (GIN) March 2015

Page 14

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 sup-

port the countries of the Americas with IPV introduction.

The modules cover important topics related to IPV introduc-

tion 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.

Read the press release

Credit: WHO/G. Hampton

Global Immunization News (GIN) March 2015

Page 15

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

Global Immunization News (GIN) March 2015

Page 16

Calendar 2015

April

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

Group on Immunization and Vaccine-Preventable Diseases (TAG)

Manila, Philippines

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 17

WHO Regional Websites Routine Immunization and New Vaccines (AFRO)

Immunization (PAHO)

Vaccine-preventable diseases and immunization (EMRO)

Vaccines and immunization (EURO)

Immunization (SEARO)

Immunization (WPRO)

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)

Organizations and Initiatives American Red Cross Child Survival Agence de Médecine Préventive Africhol EpiVacPlus LOGIVAC Project SIVAC Centers for Disease Control and Prevention Polio Global Vaccines and Immunization Johns Hopkins International Vaccine Access Center Vaccine Information Management System JSI Africa Routine Immunization Systems Essentials Project IMMUNIZATIONbasics Maternal and Child Health Integrated Program (MCHIP) PAHO ProVac Initiative PATH Vaccine Resource Library Rotavirus Vaccine Access and Delivery Malaria Vaccine Initiative Meningitis Vaccine Project RHO Cervical Cancer

Sabin Vaccine Institute Sustainable Immunization Financing UNICEF Immunization Supplies and Logistics USAID Maternal and Child Health Integrated Program WHO Department of Immunization, Vaccines & Biologicals New and Under-utilized Vaccines Implementation ICO Information Centre on HPV and Cancer Immunization financing Immunization service delivery Immunization surveillance, assessment and monitoring SIGN Alliance Other Coalition Against Typhoid Dengue Vaccine Initiative European Vaccine Initiative Gardasil Access Program Gavi the Vaccine Alliance International Association of Public Health Logisticians International Vaccine Institute Measles & Rubella Initiative Multinational Influenza Seasonal Mortality Study TechNet-21 Vaccines Today

UNICEF Regional Websites Immunization (Central and Eastern Europe)

Immunization (Eastern and Southern Africa)

Immunization (South Asia)

Immunization (West and Central Africa)

Child survival (Middle East and Northern Africa)

Health and nutrition (East Asia and Pacific)

Health and nutrition (Americas)

Links

Global Immunization News (GIN) March 2015