The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have licensed an Ebola vaccine, just 90 days after World Health Organization (WHO) pre-qualification. Registration of the vaccine is expected 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.
“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 accelerated the licensing and roll-out of the Ebola vaccine by certifying that it met the organization’s standards for quality, safety and efficacy in its fastest vaccine pre-qualification process ever, announced in November 2019.
The speed with which this has been achieved has been made possible by a different approach, where national licensing procedures were done in parallel based on one single scientific review process. Usually, these process 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.
“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). Preliminary study results have shown a 97.5% vaccine efficacy. 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.