FDA accepts Biologics License Application for V920 Ebola vaccine
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
A top priority… remains achieving registration of V920 and regulatory approval of our German manufacturing site”
The European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) for V920 to review.
Since May 2018, more than 245,000 1.0mL of the treatment have been donated and shipped by Merck, the drug maker, to combat Ebola. According to the pharmaceutical company, more than 190,000 additional 1.0mL investigational doses are available and ready to ship at the World Health Organization’s (WHO) request.
“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 US government toward its development and licensure,” said Dr Paula Annunziato, vice president, Merck Research Laboratories.
“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,” Annunziato continued.