Professional Documents
Culture Documents
Rev. 1
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WHO/EVD/Meet/HIS/16.1
Contents
Contents ..................................................................................................................................... 2
Abbreviations & acronyms .......................................................................................................... 3
Executive Summary ................................................................................................................... 4
Introduction ................................................................................................................................ 5
Session I: External factors that affect GEVIT’s work ................................................................... 6
Session II: Country situation and challenges for preparedness................................................. 10
Session III: Presentation of the GEVIT working groups’ work ................................................... 12
Session V: Review of GEVIT documents and materials............................................................ 15
Session VI: Agreement and next phase .................................................................................... 16
Annexes
Annex 1: Programme................................................................................................................ 17
Annex 2: List of Participants ..................................................................................................... 20
Vaccination continues to be implemented in the context of the clinical trials, with contacts and contacts of
contacts being targeted for vaccination. Survivors and their contacts are not being vaccinated however. At
present, the objective is to make the vaccine available to the closest intimate partners of the survivors, but
further rigorous evaluation of this strategy is required within a clinical study context. The virus lingers in some
survivors and follow-up of survivors is taking place. There is limited information on how survivors become
sick once again, and recent investigation could not identify an obvious chain of transmission. Research is
ongoing in this regard.
At present, it is not known how long vaccine protection will last, and this is an important factor to consider
when planning vaccine introduction. Ebola, unlike afflictions such as measles, does not affect swathes of
people in a community, but rather it affects individuals and their close contacts. The disease can be
controlled and stopped, however, through effective public-health measures.
Emergency-use recommendation
Mr Olivier Lapujade, Scientist, Prequalification Team, Essential Medicines and Health Products, WHO
headquarters, Geneva, Switzerland. Presentation available electronically.
Highlights
The emergency-use assessment and listing process (EUAL) is not a WHO prequalification process. It is a
time-limited special circumstance procedure, where vaccines are assessed as fit for use in an emergency
situation, despite the fact that not all the data usually required is available. The criteria for the use of an
EUAL include a public-health emergency of international concern (PHEIC) declared by the WHO Director
General. The 2014 Ebola crisis highlighted the need for such an emergency process, and similar procedures
are now also available for medicines and vitro diagnostics.
EUAL is not a regulatory authorization, but rather a recommendation for countries to provide guidance in
their decision-making process as to whether to use the vaccine or not. The criteria required for an EUAL
include: a declared PHEIC; the lack of routine marketing authorization of a vaccine for the disease in
question; a vaccine manufactured in accordance with the WHO Good Manufacturing Practices (GMP) and
manufactured in a country whose National Regulatory Authority (NRA) is assessed as functional according
to the WHO vaccine regulatory standards, and an attestation from the producer of the intention to complete
the vaccine development and apply for WHO prequalification. All the documents required for a clinical trial
authorization are also needed for requesting an EUAL. These include technical documents relating to
vaccine safety and performance, including documentation of the consistency of vaccine batches.
Liberia presentation
Mr Adolphus Clarke, Deputy EPI Manager, Ministry of Health and Social Welfare, Monrovia, Liberia.
Presentation available electronically.
Highlights
The country has many vaccination challenges coming up in 2016; campaigns, inactivated polio vaccine (IPV)
introduction, trivalent to bivalent oral polio vaccine (tOPV-bOPV) switch and rebuilding the EPI programme,
among others. The introduction of Ebola vaccine will be possible, but the country does not have capacity for
a -80°C cold chain.
A great lesson learned from the Ebola epidemic is that surveillance is not a stand-alone activity. The
surveillance system is moving towards a “One Health” approach with an integrated system within the
infectious disease reporting system (IDRS) for pharmacovigilance, vaccine-preventable diseases and Ebola.
A strong surveillance system will be crucial to quickly implement vaccination after detection of the first
confirmed case. Regarding social mobilization related to survivors, the country uses the reaching every
district (RED) strategy with the psychosocial support pillar to improve community ownership, working with
traditional healers and teachers, etc. Survivors were also part of this effort. After being declared Ebola-free,
Liberia had a new confirmed case, hence the EPI recovery plan is important. The country will need to use
the lessons learned from Ebola to move forward. There is a need to move away from vertical towards
integrated programmes.
The choice of the vaccination strategy to be implemented needs to be made in the light of the local context.
The choice of a vaccination strategy should be an operational decision based on the epidemiology of the
outbreak, and countries can combine different strategies depending on the number of cases and funding
available to purchase the vaccine. Strong political will at country level is imperative. An active communication
system needs to be established that provides accurate information in order to gain trust. Since the vaccines
are still in clinical trials, there is resistance to vaccination and this needs to be managed. For vaccine
introduction, countries should initiate the campaign from a communication perspective, i.e. preparing people
with clear communication messages regarding the type of vaccination strategy and the objectives prior to the
vaccination campaign, not after the campaign has started. Community engagement and involvement should
start two weeks prior to a vaccination campaign as it takes time to prepare the community. At present, this is
the last action on the list. Vaccination brings hope and the benefits of vaccine can build trust; therefore, the
community needs to understand what the benefits of the vaccine are.
The pros and cons of vaccination strategies, e.g. mass (geographic) vaccination versus Ring vaccination,
are discussed in the guide based on the knowledge currently available and consistent with SAGE’s
provisional recommendations.
*unable to attend