On Feb. 2, 2021, VBI Vaccines announced that the FDA had accepted its filing of the Biologics License Application (BLA) for the Companyﾒs 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2021.