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
| Date | Article |
|---|---|
| Dec 1, 2021 | Approval FDA Approves PreHevbrio (Hepatitis B Vaccine (Recombinant)) for the Prevention of Hepatitis B in Adults |
Further information
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