World Health OrganizationEssential

World Health Organization
Essential Medicines and Health Products (EMP)
Global Vaccine Safety Initiative (GVSI)
Fourth meeting
Evian-les-Bains, France
14−15 October 2015
CONTENTS
INTRODUCTION .................................................................................................... 1
Opening.......................................................................................................................1
Key vaccine safety events in 2014−2015 .......................................................................1
Global Vaccine Safety Initiative: review of achievements..............................................2
LESSONS LEARNED FROM COUNTRY EXPERIENCES ................................................ 4
Strengthening AEFI surveillance systems ......................................................................4
Using new vaccine introduction as entry point for strengthening AEFI surveillance
systems in Burkina Faso.................................................................................................... 4
AEFI surveillance system and activities in Viet Nam......................................................... 5
Vaccine safety in Iran: what motivates health workers to report AEFI cases?................. 5
Australian vaccine safety surveillance : two examples of models.... Error! Bookmark not
defined.
Responding to vaccine safety reports ...........................................................................7
Investigating vaccine safety concerns and preparing for immunization among high-risk
groups in Sri Lanka............................................................................................................ 7
Signal detection by quantitative methods: the experience of Chile ................................ 8
Signal detection and assessment by US CDC.................................................................... 9
Managing a vaccine safety crisis...................................................................................9
Managing a crisis in the Democratic Republic of the Congo .......................................... 10
Managing a vaccine safety crisis in Jammu and Kashmir, India ..................................... 10
Kenya: the tetanus vaccine controversy......................................................................... 11
Immunization anxiety-related reactions and mass psychogenic reactions: case studies 12
WHO European Region................................................................................................... 12
WHO South-East Asia Region.......................................................................................... 14
WHO Americas Region.................................................................................................... 14
Discussion ....................................................................................................................... 15
REGIONAL AND GLOBAL INITIATIVES....................................................................15
Improving vaccine safety communication ................................................................... 15
Global dissemination of balanced evidence-based vaccine safety information: the
Vaccine Safety Net.......................................................................................................... 16
The European vaccine safety communication training project...................................... 16
Improving AEFI investigation...................................................................................... 17
Standardizing AEFI investigation methodology: a South-East Asia regional workshop . 18
New WHO course on AEFI investigation: experience from Sudan ................................. 18
Monitoring substandard, spurious, falsely-labelled, falsified, counterfeit medical
products (SSFFC) ........................................................................................................ 19
New vaccines............................................................................................................. 20
Ebola vaccines................................................................................................................. 20
Malaria vaccine............................................................................................................... 22
Dengue vaccine............................................................................................................... 22
STAKEHOLDERS’ PERSPECTIVES AND PROJECTS ....................................................23
Immunization safety in pregnancy: the GAIA project................................................... 23
Vaccine pharmacovigilance and PATH......................................................................... 24
Pharmacovigilance projects of Agence de Médecine Préventive.................................. 25
Vaccine safety surveillance and response: a strategic objective for GAVI ..................... 26
Bill & Melinda Gates Foundation: safety surveillance update ...................................... 27
CLOSING ..............................................................................................................28
ii
INTRODUCTION
Opening
The fourth meeting of the Global Vaccine Safety Initiative (GVSI) was held in Evian-lesBains,
France, on 14−15 October 2015. The objective of the meeting was to allow
representatives of WHO Member States and partners to exchange information on
national and international vaccine pharmacovigilance activities, share and explore new
ideas, strengthen partnerships and collaboration, and plan for further developments.
The agenda of the meeting is contained in Annex 1.
Participants came from over 30 WHO Member States as well as from international
agencies and the vaccine industry. The list of participants is contained in Annex 2.
Participants were welcomed to the meeting by Dr Clive Ondari, Coordinator of the
Safety and Vigilance team at WHO, who summarized GVSI’s role in ensuring the safety
of vaccines in all countries. Dr Ondari urged the meeting not only to share information
but also to explore new opportunities in vaccine safety, to strengthen existing
collaborative mechanisms and build new partnerships, and to define the strategies that
are needed for the future development of global vaccine safety.
Mr Sten Olsson was requested to chair the proceedings on day 1.
Key vaccine safety events in 2014−2015
Dr Patrick Zuber of WHO reported on key recent events linked to the GVSI. He outlined
the process for safety monitoring when a new vaccine product is introduced, noting that
once it is on the market spontaneous reporting can reveal post-licensure signals and
even previously unknown risks. However, active surveillance and special studies in
addition can add information on signals from clinical trials and from adverse events of
special interest. It is particularly important that a country which is introducing a vaccine
for the first time should do more than just wait for adverse events following
immunization (AEFI) to be reported and should carry out active surveillance and studies
as well. As evidence is accumulated, policy adjustments may need to be made.
Rotavirus vaccination that put children at risk of intussusception was cited as an
example of evidence that led to policy change. Intussusception shows in a very short
time period post-vaccination so study needs to take place at that time to identify cases.
Another vaccine producing concern is the HPV vaccine. Dr Zuber questioned some
reports that seem to link HPV vaccination to auto-immune diseases and other problems
in pre-adolescent girls, pointing out that they were not epidemiological studies. Indeed,
large epidemiological studies with many subjects have shown no link between HPV
vaccination and these conditions. The vaccine community needs to clarify these
1
concerns. To do so it will be important to accumulate local data from across the world in
order to be able to analyse a large body of data.
Another important focus is maternal immunization since there is evidence that
vaccination of pregnant women may give important benefits to both mothers and
infants. New and upcoming vaccines could have specific benefits during pregnancy.
However, few data are available although some studies sponsored by the Bill & Melinda
Gates Foundation are underway. Maternal immunization is under consideration by
WHO’s Strategic Advisory Group of Experts (SAGE) on immunization. Theoretical
concerns exist regarding fetal risk and there are also some methodological issues in
assessing vaccine safety as well as manufacturers’ liability – with vaccine safety
compensation being a growing area –, making vaccinations for pregnant women an
uncertain area at present.
A further issue on the SAGE agenda is the switch to bivalent oral poliovirus vaccine
(OPV), possibly in 2016. The current immunization strategy requires all countries to use
at least one dose of inactivated poliovirus vaccine (IPV), which is an old vaccine but
which is now being introduced for the first time in some countries and therefore is a
new vaccine in those places. IPV contains traces of streptomycin and could potentially
cause reactions. However, GACVS examined the IPV safety profile in 2013 and judged it
to cause no serious AEFI.
New vaccine products in the pipeline include those for dengue, malaria and Ebola. This
means that active surveillance studies need to be designed and employed in countries
where these vaccines will be used.
Another growing concern is “vaccine hesitancy” which refers to delay in acceptance, or
refusal of, vaccination despite the availability of vaccination services. Hesitancy,
including mass reactions after vaccinations, is a serious issue that needs to be dealt with
more seriously and effectively. The journal Vaccine published a special issue on vaccine
hesitancy in 2015, stressing that immunization programmes must systematically and
comprehensively address not o

Kết quả (Việt) 1:

Tổ chức y tế thế giớiThuốc men cần thiết và các sản phẩm y tế (EMP)Sáng kiến toàn cầu vắc xin an toàn (GVSI)Cuộc họp thứ tưEvian-les-Bains, Pháp14−15 tháng 10 năm 2015NỘI DUNGINTRODUCTION .................................................................................................... 1Opening....................................................................................................................... 1Các sự kiện quan trọng vắc xin an toàn trong 2014−2015... 1Sáng kiến toàn cầu vắc xin an toàn: xem xét lại những thành tựu... 2BÀI HỌC KINH NGHIỆM TỪ NHỮNG KINH NGHIỆM QUỐC GIA... 4Tăng cường hệ thống giám sát AEFI... 4Bằng cách sử dụng mới vắc xin giới thiệu như là điểm nhập cảnh cho tăng cường giám sát AEFIsystems in Burkina Faso.................................................................................................... 4AEFI giám sát hệ thống và các hoạt động tại Việt Nam... 5Vắc xin an toàn ở Iran: những gì thúc đẩy nhân viên y tế để báo cáo AEFI trường hợp... 5Úc vắc xin an toàn giám sát: hai ví dụ về mô hình... Lỗi! Đánh dấu khôngđược xác định.Đáp ứng với vắc xin an toàn báo cáo... 7Điều tra vắc xin an toàn mối quan tâm và chuẩn bị cho tiêm chủng trong số nhiều rủi rogroups in Sri Lanka............................................................................................................ 7Tín hiệu phát hiện bằng phương pháp định lượng: kinh nghiệm của Chile... 8Tín hiệu phát hiện và đánh giá bởi CDC chúng tôi... 9Quản lý một vắc xin an toàn cuộc khủng hoảng... 9Quản lý một cuộc khủng hoảng tại cộng hòa dân chủ Congo... 10Quản lý một cuộc khủng hoảng vắc xin an toàn bang Jammu và Kashmir, Ấn Độ... 10Kenya: những tranh cãi tiêm uốn ván... 11Tiêm chủng lo lắng liên quan đến phản ứng và khối lượng psychogenic phản ứng: nghiên cứu trường hợp 12WHO European Region................................................................................................... 12WHO South-East Asia Region.......................................................................................... 14WHO Americas Region.................................................................................................... 14Discussion ....................................................................................................................... 15SÁNG KIẾN KHU VỰC VÀ TOÀN CẦU... 15Cải thiện vắc xin an toàn giao tiếp... 15Phổ biến toàn cầu bằng chứng dựa trên cân bằng vắc xin an toàn thông tin: CácVaccine Safety Net.......................................................................................................... 16Châu Âu vắc xin an toàn giao tiếp dự án đào tạo... 16Cải thiện AEFI điều tra... 17Tiêu chuẩn hóa AEFI điều tra phương pháp: một hội thảo khu vực đông nam á. 18Mới người khóa học AEFI điều tra: kinh nghiệm từ Sudan... 18Giám sát y tế không đạt chuẩn, giả mạo, sai với nhãn hiệu, giả, giả mạoproducts (SSFFC) ........................................................................................................ 19New vaccines............................................................................................................. 20Ebola vaccines................................................................................................................. 20Malaria vaccine............................................................................................................... 22Dengue vaccine............................................................................................................... 22STAKEHOLDERS’ PERSPECTIVES AND PROJECTS ....................................................23Immunization safety in pregnancy: the GAIA project................................................... 23Vaccine pharmacovigilance and PATH......................................................................... 24Pharmacovigilance projects of Agence de Médecine Préventive.................................. 25Vaccine safety surveillance and response: a strategic objective for GAVI ..................... 26Bill & Melinda Gates Foundation: safety surveillance update ...................................... 27CLOSING ..............................................................................................................28iiINTRODUCTIONOpeningThe fourth meeting of the Global Vaccine Safety Initiative (GVSI) was held in Evian-lesBains,France, on 14−15 October 2015. The objective of the meeting was to allowrepresentatives of WHO Member States and partners to exchange information onnational and international vaccine pharmacovigilance activities, share and explore newideas, strengthen partnerships and collaboration, and plan for further developments.The agenda of the meeting is contained in Annex 1.Participants came from over 30 WHO Member States as well as from internationalagencies and the vaccine industry. The list of participants is contained in Annex 2.Participants were welcomed to the meeting by Dr Clive Ondari, Coordinator of theSafety and Vigilance team at WHO, who summarized GVSI’s role in ensuring the safetyof vaccines in all countries. Dr Ondari urged the meeting not only to share informationbut also to explore new opportunities in vaccine safety, to strengthen existingcollaborative mechanisms and build new partnerships, and to define the strategies thatare needed for the future development of global vaccine safety.Mr Sten Olsson was requested to chair the proceedings on day 1.Key vaccine safety events in 2014−2015Dr Patrick Zuber of WHO reported on key recent events linked to the GVSI. He outlinedthe process for safety monitoring when a new vaccine product is introduced, noting thatonce it is on the market spontaneous reporting can reveal post-licensure signals andeven previously unknown risks. However, active surveillance and special studies inaddition can add information on signals from clinical trials and from adverse events ofspecial interest. It is particularly important that a country which is introducing a vaccinefor the first time should do more than just wait for adverse events followingimmunization (AEFI) to be reported and should carry out active surveillance and studiesas well. As evidence is accumulated, policy adjustments may need to be made.Rotavirus vaccination that put children at risk of intussusception was cited as anexample of evidence that led to policy change. Intussusception shows in a very shorttime period post-vaccination so study needs to take place at that time to identify cases.Another vaccine producing concern is the HPV vaccine. Dr Zuber questioned somereports that seem to link HPV vaccination to auto-immune diseases and other problemsin pre-adolescent girls, pointing out that they were not epidemiological studies. Indeed,large epidemiological studies with many subjects have shown no link between HPVvaccination and these conditions. The vaccine community needs to clarify these1concerns. To do so it will be important to accumulate local data from across the world inorder to be able to analyse a large body of data.Another important focus is maternal immunization since there is evidence thatvaccination of pregnant women may give important benefits to both mothers andinfants. New and upcoming vaccines could have specific benefits during pregnancy.However, few data are available although some studies sponsored by the Bill & MelindaGates Foundation are underway. Maternal immunization is under consideration byWHO’s Strategic Advisory Group of Experts (SAGE) on immunization. Theoreticalconcerns exist regarding fetal risk and there are also some methodological issues inassessing vaccine safety as well as manufacturers’ liability – with vaccine safetycompensation being a growing area –, making vaccinations for pregnant women an
uncertain area at present.
A further issue on the SAGE agenda is the switch to bivalent oral poliovirus vaccine
(OPV), possibly in 2016. The current immunization strategy requires all countries to use
at least one dose of inactivated poliovirus vaccine (IPV), which is an old vaccine but
which is now being introduced for the first time in some countries and therefore is a
new vaccine in those places. IPV contains traces of streptomycin and could potentially
cause reactions. However, GACVS examined the IPV safety profile in 2013 and judged it
to cause no serious AEFI.
New vaccine products in the pipeline include those for dengue, malaria and Ebola. This
means that active surveillance studies need to be designed and employed in countries
where these vaccines will be used.
Another growing concern is “vaccine hesitancy” which refers to delay in acceptance, or
refusal of, vaccination despite the availability of vaccination services. Hesitancy,
including mass reactions after vaccinations, is a serious issue that needs to be dealt with
more seriously and effectively. The journal Vaccine published a special issue on vaccine
hesitancy in 2015, stressing that immunization programmes must systematically and
comprehensively address not o