Hepatitis B vaccine for adults approved by FDA

PreHevbrio, a 3-antigen vaccine for adults formulated to prevent infection caused by all known subtypes of the hepatitis B virus, received FDA approval.

The vaccine, developed by VBI Vaccines Inc. (Nasdaq: VBIV), a Cambridge, Mass., biopharmaceutical company, contains the S, pre-S2, and pre-S1 HBV surface antigens. It is the only approved 3-antigen vaccine for adults in the United States.

The approval was based on the results from two phase 3 clinical studies, PROTECT and CONSTANT. Data from the studies were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. The studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. 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 1-2 days.

PreHevbrio is expected to be available in the U.S. in the first quarter of 2022, and VBI has partnered with Syneos Health for the past two years to ensure commercial readiness.

"This is a substantial achievement that demonstrates the VBI team’s ability to progress vaccine candidates from the clinic through to approval,” Jeff Baxter, VBI’s president and CEO, said in a statement. “This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections. We would like to thank the study participants, clinical site investigators, our employees, and all who contributed to this achievement, and we look forward to working with public health and advocacy organizations as we join the fight against hepatitis B."

The Hepatitis B Foundation has a goal of eliminating HBV in the United States by 2030.