Merck & Co. announced Monday that the European Commission has granted conditional marketing approval to Ervebo (rVSVΔG-ZEBOV-GP) for the active immunisation of individuals aged 18 years or older against Ebola virus disease caused by the Zaire strain of the virus. The vaccine, also known as V920, received a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) last month and is currently under priority review by the FDA, with a decision expected by March 14, 2020.
According to Merck, the EU approval is based on data submitted to the EMA for accelerated assessment in March. The vaccine is already used, as part of a specific protocol, to protect people at risk of infection, such as healthcare workers or people who have been exposed to infected individuals. Merck said it has so far donated more than 250,000 1-mL doses of the vaccine to the World Health Organization (WHO) for use in outbreak response efforts occurring in the Democratic Republic of Congo (DRC) since May last year.
The company noted that the approval allows it to initiate manufacturing of licensed doses of Ervebo in Germany which are expected to start becoming available in the third quarter of 2020. It also reiterated a pledge to manufacture additional doses of the vaccine over the year ahead as part of ongoing response efforts in the DRC.
CEO Kenneth Frazier said the drugmaker is "continuing to work with the FDA and the African countries on their regulatory reviews over the coming months and with the WHO on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most." The company licensed Ervebo, a recombinant, replication-competent vaccine, from NewLink Genetics in 2014.
Meanwhile, batches of Johnson & Johnson's Ebola vaccine candidate Ad26-ZEBOV-GP arrived earlier this month in the DRC, where they will be provided under approved protocols to targeted at-risk populations. Johnson & Johnson recently submitted a European marketing application for the vaccine regimen, which consists of Ad26.ZEBOV as the first dose, and MVA-BN-Filo as the second dose, administered approximately eight weeks later.
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