Update: First Ever Ebola Vaccine Gets US and EU Approval

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Update (20/12/2019): After getting conditional approval in Europe in November, Merck has received FDA approval for its Ebola vaccine, the first to be approved in both regions. 

Published on 13/11/2019

The big pharma company Merck has won a conditional marketing authorization from the European Commission for the Ebola vaccine Ervebo, the first to be approved.

Ervebo has been approved in Europe to vaccinate adults against Ebola, a life-threatening viral infection that kills up to 90% of the people it infects. Ervebo’s approval allows Merck to stockpile and widely distribute the vaccine, including to African countries where the virus is most prevalent. Merck will commence the manufacture of the vaccine in Germany and expects it to be available by late 2020. The approval is conditional upon Merck providing further data about the vaccine to the EMA in post-marketing safety reports.

Merck’s vaccine is based on a recombinant virus called vesicular stomatitis virus, whose surface proteins have been replaced by those from the Ebola virus. The vaccine cut the rate of Ebola transmission by 97.5% in a field trial during an outbreak in the Democratic Republic of the Congo earlier this year.

Several other vaccines are also in development. For example, the Chinese biotech CanSino and the Russian Gamaleya Research Institute have developed vaccines to be used in emergencies in their host countries. Another vaccine developed by Janssen and the Danish company Bavarian Nordic is currently under review by the EMA and the companies expect to receive market approval in 2020.

According to Corina Ramers-Verhoeven, Communications Leader at Janssen, the latest approval of Merck’s vaccine is a “welcome advance in the fight against Ebola.”

Having multiple approved vaccines would also be advantageous for epidemic preparedness, helping to ensure vaccine supply and avoiding stockouts,” she told me.

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