FDA accepts biologics license application for Mercado-Ontom Ebola vaccine V920
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Last Update: 2020-06-08
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Source: Internet
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Author: User
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Today, http://
the http:// of the U.SFDA(http://) has accepted an application for a biologic license (BLA) for its Ebola vaccine to prevent disease caused by the Ebola virus, the http:// http:// company announced todayThe FDA also qualified for the V920 priority review and is expected to respond by March 14 next yearMarch 2019, the EuropeanMedicines(http://Authority (EMA) has accepted a regulatory application for V920about V920
V920 is made up of modified hydrohersetic stomatitis virus (VSV) and important glycoproteins on the surface of the Ebola virusAlthough the V920 has not yet been approved in the United States and the European Union, but due to the severity of the outbreak, Mercado has responded to the World Health Organization (WHO) request for a large number of research preparationsThe application was submitted based on clinical data that V920 had accumulated while protecting people from the Ebola virus in CongoAccording to preliminary WHO data, V920 may be effective in protecting individuals from Ebola virus infection Of the more than 93,000 high-risk people vaccinated against V920, only 71 were infected with the virus, and most of those infected had developed symptoms of the disease before the vaccine was effective safety
V920 showed good safety and tolerance in a randomized, double-blind, placebo-controlled 3-stage clinical study involving 1,197 health (http:// adults
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