EBOLA/EVD [to 9 January 2016]
Public Health Emergency of International Concern (PHEIC); “Threat to international peace and security” (UN Security Council)

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Ebola Situation Report – 6 January 2016
SUMMARY
:: No confirmed cases of Ebola virus disease (EVD) were reported in the week to 3 January. On 29 December, WHO declared that human-to-human transmission of Ebola virus has ended in Guinea, after the completion of 42 days with zero cases since the last person confirmed to have EVD received a second consecutive negative blood test for Ebola virus RNA. Guinea has now entered a 90-day period of heightened surveillance. Guinea, Liberia, and Sierra Leone have all now succeeded in interrupting human-to-human transmission linked to the original outbreak in West Africa.

:: Human-to-human transmission linked to the most recent cluster of cases in Liberia will be declared to have ended on 14 January 2016, 42 days after the 2 most-recent cases received a second consecutive negative test for Ebola virus, if no further cases are reported. In Sierra Leone, human-to-human transmission linked to the primary outbreak was declared to have ended on 7 November 2015. The country has now entered a 90-day period of enhanced surveillance scheduled to conclude on 5 February 2016.

:: The most recent cluster of cases in Liberia was the result of the re-emergence of Ebola virus that had persisted in a previously infected individual. Although the probability of such re-emergence events is low, the risk of further transmission following a re-emergence underscores the importance of implementing a comprehensive package of services for survivors that includes the testing of appropriate bodily fluids for the presence of Ebola virus RNA. The governments of Liberia and Sierra Leone, with support from partners including WHO and the US Centres for Disease Control and Prevention, have implemented voluntary semen screening and counselling programmes for male survivors in order to help affected individuals understand their risk and take necessary precautions to protect close contacts. 405 male survivors had accessed semen screening services up to 3 January 2016 in Liberia and Sierra Leone. A network of clinical services for survivors is also being expanded in Liberia and Sierra Leone, with plans for comprehensive national policies for the care of EVD survivors due to be completed in January 2016. To date approximately 3000 survivors have accessed basic care services…

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WHO – Ebola Vaccine Target Product Profile
5 January 2016 :: 16 pages
Overview
During the course of the high level WHO meetings on Ebola vaccine development, it was agreed that WHO would develop Ebola vaccine target product profiles (TPP) to provide guidance on WHO’s preferences for Ebola vaccines of two categories (for reactive use and prophylactic use).
The target audience for the WHO Ebola vaccine TPP are all those working to improve characteristics of currently tested Ebola vaccines. The TPP is also relevant to those developing Ebola vaccines that have not yet reached the clinical development phase.
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WHO Ebola Vaccine TPP pdf, 403kb
Excerpt
This document considers two scenarios for use of an Ebola virus disease (EVD) vaccine, which have different preferred characteristics:
a) Reactive/emergency use in the face of an outbreak to prevent EVD in vaccinated individuals as well as interrupt chains of virus transmission to terminate outbreaks. Use will be in populations experiencing an outbreak, in populations geographically close to an outbreak and at high risk for importation of EVD cases from areas experiencing an outbreak:
:: Durability of protection: Less critical than rapidly achieving high rates of protection as the emphasis is interrupting transmission and terminating the outbreak.
:: Stability/storage: Amenable to stockpiling for future outbreaks of EVD.
:: Risk/benefit profile: Acceptability based on the assumption those vaccinated are at high risk of exposure to Ebola virus with relatively high EVD-associated mortality rate.

b) Prophylactic use to protect frontline workers (including healthcare workers, deploying international workers and others at particularly high risk of EVD due to their profession such as ancillary staff and those dealing with burials)
:: Durability of protection: A more prominent preferred characteristic than for reactive/emergency use
:: Risk/benefit profile: assumes that some of those vaccinated may not be as at high risk as the target group for reactive use.

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Introduction
This document is intended to serve as guidance for scientists, regulators, and funding agencies, and for industry groups. It is relevant to those groups who wish to obtain WHO policy recommendations for use, and WHO prequalification of their products to maximise supply volumes for use of EVD vaccines, and meet the public health need related to future EVD outbreaks.
In order to reach the stage of use in countries most affected by Ebola outbreaks, vaccines will need to be prequalified by WHO, and be included within the remit of WHO policy recommendations for use. An essential requirement prior to WHO prequalification is licensure by an NRA considered functional by WHO.

All the requirements contained in WHO guidelines for WHO policy recommendation and prequalification will also apply. The criteria below lay out some of the considerations that will be relevant in WHO’s case-by-case assessments of EVD vaccines in the future.
None of the characteristics in the tables below dominates over any other. Therefore should a vaccine’s profile be sufficiently superior to the critical characteristics under one or more categories, this may outweigh failure to meet another specific critical characteristic. Vaccines which fail to meet multiple critical characteristics are unlikely to achieve favourable outcomes from WHO’s processes.

A generic description of WHO’s Vaccine Prequalification process can be found at the end of this document…