PreHevbrio™ (hepatitis B vaccine [recombinant]) is now available for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults 18 year of age and older.

PreHevbrio contains the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface antigens. The vaccine is administered as a 3-dose series (each 1.0mL) via intramuscular injection on a 0-, 1- and 6-month schedule. 

The approval was based on data from 2 randomized, double-blind phase 3 studies, PROTECT (CinicalTrials.gov Identifier: NCT03393754) and CONSTANT (CinicalTrials.gov Identifier: NCT03408730), which compared the safety and immunogenicity of PreHevbrio to Engerix-B® in individuals 18 years of age and older. Findings from both studies demonstrated that the seroprotection rate induced by PeHevbrio compared with Engerix-B was noninferior (primary endpoint).


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The most common local reactions with PreHevbrio were injection site pain and tenderness, while systemic reactions included headache, fatigue, and myalgia.

PreHevbrio is supplied as a single-dose vial (1.0mL). The wholesale acquisition cost has been set at $64.75 per dose.

“We are proud to announce the US availability of PreHevbrio, a significant milestone in our effort to be part of the fight against hepatitis B,” said Jeff Baxter, VBI’s President and CEO. “This launch coincides with the swell of momentum following the ACIP’s November 2021 unanimous vote to move to a universal HBV vaccination recommendation for all adults age 19-59, and its February 2022 decision to include PreHevbrio in its list of recommended adult HBV vaccines.”

References

  1. VBI Vaccines announces PreHevbrio™ is now available in the United States for the prevention of hepatitis B in adults. News release. VBI Vaccines Inc. Accessed March 29, 2022. https://www.vbivaccines.com/press-releases/prehevbrio-available/
  2. PreHevbrio. Package insert. VBI Vaccines Inc.; 2021. Accessed December 1, 2021. https://www.prehevbrio.com/wp-content/uploads/2021/11/PreHevbrio-Full-Prescribing-Information.pdf

This article originally appeared on MPR