Merck has announced that the US Food and Drug Administration (FDA) has accepted a biologics license application for, and granted priority review status, to its investigational Ebola vaccine, V920.
This follows the US regulator granting breakthrough designation to the preventive vaccine in 2016 and the European Medicines Agency accepting a marketing authorisation application for V920 in March this year.
Merck has also made submissions to the World Health Organization (WHO) and the African Vaccine Regulatory Forum to achieve pre-qualification status.
Merck vice-president Dr Paula Annunziato said: “Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine.
“FDA’s priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure.
“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. We look forward to continuing to work with the FDA throughout the review process.”
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Due to the seriousness of the current Ebola outbreak in the Democratic Republic of Congo, Merck has already shipped 245,000 investigational doses to the WHO and has 190,000 available to be shipped immediately at the request of the organisation.
Dr Annunziato continued: “We continue to be proud and humbled to provide our investigational V920 Ebola vaccine as an additional tool in support of the comprehensive public health response efforts against the current Ebola outbreak.”
V920 was originally discovered and developed by the Public Health Agency of Canada, and was then licensed to a NewLink Genetics subsidiary. During the 2014-6 Ebola outbreak in West Africa, Merck licensed V920 from NewLink Genetics and has continued to broaden a clinical development programme for the vaccine.
Another Ebola vaccine licensed by Merck from Canada’s Public Health Agency – rVSV-ZEBOV – was the first vaccine brought to the market against the Ebola Zaire virus.