February 2, 2021 -- The U.S. Food and Drug Administration (FDA) has accepted the biologics license application (BLA) submitted by VBI Vaccines for its 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus in adults.
The FDA has set a prescription drug user fee act (PDUFA) target action date, the deadline by which the FDA must review the application, of November 30, 2021. In the filing notification letter, the FDA noted that it will not hold an advisory committee meeting to discuss the application.
The BLA is supported by data from two phase III clinical trials that were designed to assess the efficacy and safety of the vaccine candidate, as well as its lot-to-lot manufacturing consistency.
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