FDA Approves Vaccine for Hepatitis B

The FDA has approved PreHevbrio, a recombinant vaccine for the prevention of hepatitis B in adults 18 years of age and older. PreHevbrio, developed by VBI Vaccines, contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved three-antigen hepatitis B virus vaccine for adults in the United States.

Chari Cohen, DrPH

“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 United States,” Chari Cohen, DrPH, senior vice president of the Hepatitis B Foundation, said in a statement.

The approval is based on data from two phase 3 clinical studies, PROTECT and CONSTANT.

The pivotal studies compared PreHevbrio with GlaxoSmithKline’s Engerix-B, a single-antigen hepatitis B vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in one to two days.

The data were published from the PROTECT study in The Lancet Infectious Diseases in May 2021 and the CONSTANT study in JAMA Network Open in October 2021.

VBI expects to make PreHevbrio available in the United States in the first quarter of 2022.