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PreHevbrio FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 6, 2021.

FDA Approved: Yes (First approved November 30, 2021)
Brand name: PreHevbrio
Generic name: hepatitis B vaccine (recombinant)
Dosage form: Injection
Company: VBI Vaccines Inc.
Treatment for: Hepatitis B Prevention

PreHevbrio (hepatitis B vaccine (recombinant)) is a 3-antigen hepatitis B vaccine indicated for the prevention of hepatitis B virus (HBV) infection in adults.

  • PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens to prevent infection caused by all known subtypes of hepatitis B virus. 
  • PreHevbrio is the first FDA-approved 3-antigen hepatitis B vaccine. Previously approved hepatitis B vaccines (Engerix-B, Recombivax HB, and Heplisav-B) are all single-antigen vaccines.
  • PreHevbrio is administered via intramuscular injection as a series of three doses on a 0-, 1- and 6-month schedule.
  • PreHevbrio may cause serious adverse reactions including severe allergic reactions. Common adverse reactions include injection site pain and tenderness, headache, fatigue, and myalgia.

Development timeline for PreHevbrio

Dec  1, 2021Approval FDA Approves PreHevbrio (Hepatitis B Vaccine (Recombinant)) for the Prevention of Hepatitis B in Adults

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.