A new hepatitis B vaccine is expected to be available in the United States early next year. The product, PreHevbrio [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults was recently approved by the FDA.

PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S., according to VBI Vaccines, Inc., a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease.

“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,” Chari Cohen, DrPH, MPH, senior vice president of the Hepatitis B Foundation, said in a VBI press release. “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.”

The ACIP voted unanimously, 15-0, to recommend hepatitis B vaccination for all adults aged 19 to 59 years. The recommendation suggests those adults, as well as adults aged 60 years or older with risk factors, “should” be vaccinated against HBV. Once fully approved, recommendations on use of the vaccine will appear in the Morbidity & Mortality Weekly Report.

The approval of PreHevbrio was based on the results from two phase lll clinical studies, PROTECT and CONSTANT, data from which were published in The Lancet Infectious Diseases and in May 2021 and JAMA Open last month.

Those 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 aged 18 years and older (91.4% vs. 76.5%), including in adults aged 45 years and older (89.4% vs. 73.1%).

The vaccine was determined to have good tolerability with no unexpected reactogenicity, with injection-site pain and tenderness, myalgia, and fatigue, all of which generally resolved without intervention in 1 to 2 days, identified as the most common adverse events in all age groups.

The CDC currently recommends the vaccine for people living with someone infected with hepatitis B, travelers to certain countries, and healthcare and public safety workers exposed to blood. In addition, those with high-risk sexual behaviors, men who have sex with men, people who inject drugs, and people who have certain medical conditions, including diabetes, are urged to talk to their doctors about getting vaccinated.

VBI has partnered with Syneos Health for the past 2 years to ensure commercial readiness of the vaccine.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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