Four African countries license Ebola vaccine
The Democratic Republic of the Congo (DRC), Burundi, Ghana and Zambia have licensed an Ebola vaccine, just 90 days after its prequalification from the World Health Organization (WHO). Registration of the vaccine is expected in additional countries in the coming weeks.
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 the US, Ervebo is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older; it does not protect against other species of Ebolavirus or Marburgvirus. The duration of protection conferred by Ervebo is unknown, as is the effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions.
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 — likely in the third quarter of 2020, according to Merck — 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 rollout of the Ebola vaccine by certifying that it met the organisation’s standards for quality, safety and efficacy in its fastest vaccine prequalification process ever. The vaccine was granted a conditional marketing authorisation by the European Commission on 11 November 2019 and approved by the US Food and Drug Administration (FDA) on 20 December 2019.
The speed with which this has been achieved was made possible by a different approach, where 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, 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.”
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