Ebola vaccine licensed by four African countries

The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have licensed the Ebola vaccine Ervebo, the World Health Organization (WHO) reported mid-February 2020. Only 90 days earlier, the vaccine had been prequalified  by WHO (Rural 21 reported). It was WHO’s fastest vaccine prequalification process ever. WHO expects registration of the vaccine in additional countries in the coming weeks.

The licensing of the vaccine means that the manufacturer can stockpile and widely distribute this vaccine to African countries at risk of Ebola virus disease outbreaks. Once licensed doses are available, use of the vaccine will not require clinical trial or other research protocols.

Nearly 300 000 people have been vaccinated

The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD outside the US and Canada). Preliminary study results have shown a 97.5 per cent vaccine efficacy. According to WHO, data also suggests that vaccinating people who are already infected reduces their chances of dying.

In response to the ongoing Ebola outbreak in the DRC, over 290 000 people have been vaccinated under compassionate use protocols. Once licensed doses are available, use of the vaccine in DRC will no longer require these protocols.

Prequalification process was accelerated by a different approach
 

The speed with which this has been achieved has been made possible by a different approach, by which national licensing procedures were done in parallel based on one single scientific review process. Usually, these processes are done one by one, which can take years. The process was led by WHO with the participation of the African Vaccine Regulatory Forum (an African network of national regulatory authorities and ethics committees), the European Medicines Agency, and Merck.

(WHO/ile)

Read more at WHO website

Rural 21 Issue 4/2015: Lessons learnt from Ebola