BioPharma

FDA accepts application for Merck Ebola vaccine

The agency is expected to rule on the vaccine by March 14 of next year. The company has shipped nearly a quarter of 1 million doses of the vaccine to the WHO for countries facing outbreaks like the Democratic Republic of the Congo.

The high-level isolation unit for Ebola patients at London’s Royal Free Hospital

The Food and Drug Administration has accepted and given priority review to an approval application for a vaccine against one of the world’s most dangerous viruses.

Kenilworth, New Jersey-based Merck & Co. said Tuesday that the FDA had accepted its biologics license application for V920, a vaccine against the Ebola Zaire virus. The agency is expected to rule on the application by March 14, 2020. The company noted that it has donated and shipped more than 245,000 1-milliliter doses of the investigational vaccine to the World Health Organization to address outbreaks of the virus in the Democratic Republic of the Congo and neighboring countries since May of last year, with another 190,000 ready for shipment upon request.

“A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site so that licensed supply can be produced over time to support global public health preparedness and health security objectives,” Merck Research Laboratories Vice President Paula Annunziato said in a statement.

The drugmaker started a rolling submission of its application to the FDA in November 2018 for V920, also known as RVSVDG-ZEBOV-GP. The European Medicines Agency accepted Merck’s application in March, and the company has worked with the FDA and EMA to apply with the WHO for prequalification status and to representatives of health authorities from the African Vaccine Regulatory Forum.

According to six-month safety data from a Phase III study published in June 2017 in the Journal of Infectious Diseases, the vaccine was shown to be well-tolerated, while another analysis of Phase III data published last month showed that immune responses to the vaccine persisted to 24 months. A published protocol for a systematic review of the effects of vaccines against Ebola noted that while no vaccine currently has regulatory approval, V920 has been granted access for emergency use. Two other candidates – the Russian vaccine GamEvac-Combi and the Chinese Ad5-EBOV – have been licensed for use in their respective countries of origin.

Photo: Dan Kitwood, Getty Images

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