PreHevbrio (VBI) was approved by the FDA in November 2021 for people age 18 years and older. It is a triple-antigen (containing S, Pre-S1, and Pre-S2 HBV surface proteins) recombinant vaccine produced in mammalian cells (Chinese hamster ovary cells), and containing an alum adjuvant. It is given intramuscularly in a 3-dose series of 1.0 mL (10 mcg) doses administered on a 0-, 1-, and 6-month schedule. The most common side effects of vaccination are injection site pain and tenderness, as well as fatigue, muscle aches, and headache.
PreHevbrio was approved based on clinical trials conducted in adults age 18 years and older that compared seroprotection rates (SPR, defined as anti-HBs of 10 mIU or higher, and indicative of protection against HBV infection) following 3 doses of PreHevbrio to rates following 3 doses of Engerix-B (GSK). The SPR for PreHevbrio among adults age 18 years or older ranged from 83.6% to 99.2% (overall, 91.2% for all adults) compared to Engerix-B, which ranged from 64.7% to 91.1% (overall, 76.5% for all adults).
PreHevbrio was included as an option for HepB vaccination of adults age 18 years or older in the current ACIP recommendations published on April 1, 2022: www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7113a1-H.pdf.
The package insert for PreHevbrio is available here: www.fda.gov/media/154561/download.