The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have licensed an Ebola vaccine, just 90 days after the World Health Organization (WHO) prequalification. In the coming weeks, additional countries are expected to register the vaccine. The vaccine licensing will allow the manufacturer to store and distribute this vaccine to countries at risk of Ebola virus outbreaks in Africa. Once licensed doses are available, the use of the vaccine will not require clinical trials or other research protocols.
“The approval of the Ebola vaccine by these countries is another milestone in the fight against this unforgiving disease,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Africa has rallied to cement hard-fought progress to keep its people safe from Ebola.”
WHO has accelerated the approval and delivery of the Ebola vaccine, attesting that in its quickest vaccine prequalification cycle ever announced in November 2019 it met the organization’s standards for quality, safety and efficacy. This was made possible by a different approach, with regional licensing processes being performed simultaneously, on the basis of a single empirical evaluation process. These processes normally take years, one by one. The process was led by the WHO with the participation of the European Medicines Agency, Merck and the African Regulatory Forum. The WHO also took on this process.
“The rapid approval of the Ebola vaccine by countries in the Africa Region helps ensure this critical prevention tool will be available when and where it is needed most,” said Dr Matshidiso Moeti, WHO Regional Director for Africa. “This kind of collaboration and innovation is a model for other health priorities.”
The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD outside the US and Canada). The results of the preliminary study showed the vaccine efficacy of 97.5 per cent. Evidence also shows that vaccinating already sick people increases their chances of dying. More than 290 000 people have been vaccinated under compassionate-use guidelines in response to the current Ebola outbreak in the DRC. When approved doses are available, such protocols will no longer be needed to use the vaccine in DRC.
Data Source: World Health Organization (WHO)