FDA Approves 3-Antigen Hepatitis B Vaccine

The US Food and Drug Administration (FDA) has approved the recombinant (PreHevbrio) hepatitis B virus (HBV) vaccine for the prevention of infections caused by all the known subtypes of HBV in adults 18 years and older.

The vaccine, developed by VBI Vaccines, is the only approve 3-antigen (S, pre-S2, and pre-S1 HBV surface antigens) HBV vaccine for adults in the US.

The Studies

The approval is based on a pair of phase 3 clinical trials called PROTECT and CONSTANT, where investigators compared the vaccine to Engerix-B, a single-antigen HBV vaccine.

In the PROTECT study, the recombinant vaccine resulted in higher rates of seroprotection in all subjects (91.4% vs. 76.5%), including adults 45 years and older (89.4% vs. 73.1%).

The vaccine was also deemed safe from both studies, with good tolerability and no unexpected reactogenicity. The majority of common adverse events were injection site pain and tenderness, myalgia, and fatigue, all of which resolved without intervention within 1-2 days.

The vaccine is expected to be publicly available early in 2022.

Reaction

"As we work to implement the ACIP’s new universal hepatitis B vaccine recommendation for all adults ages 19-59, as voted on in November, we benefit from having more tools, including this newly approved 3-antigen hepatitis B vaccine," said Chari Cohen, DrPH, MPH, Senior Vice President of the Hepatitis B Foundation, in a statement.

"Having more vaccine options will help us effectively expand vaccine uptake, ensure more people are protected from hepatitis B infection, and reach the 2030 goal of eliminating hepatitis B in the U.S."