FDA approves trivalent hepatitis B vaccine for adults
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VBI Vaccines announced that the FDA has approved the company’s recombinant trivalent hepatitis B vaccine, PreHevbrio, for adults aged 18 years or older.
According to VBI Vaccines, PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens and is the only approved three-antigen HBV vaccine for adults.
The approval came less than a month after the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend HBV vaccination for all adults aged 19 to 59 years and those aged 60 years or older with risk factors. The ACIP also said adults aged 60 years or older with no known risk factors for HBV infection “may” receive an HBV vaccine.
“As we work to implement the ACIP’s new universal hepatitis B vaccine recommendation ... we benefit from having more tools, including this newly approved three-antigen hepatitis B vaccine,” Chari Cohen, DrPH, MPH, senior vice president of the Hepatitis B Foundation, said 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.”
The approval of PreHevbrio was based on the results of two phase 3 studies that compared the vaccine with a monovalent HBV vaccine. Adults aged 18 years and older who received PreHevbrio elicited higher rates of seroprotection (91.4% vs. 76.5%). This included adults aged 45 years and older (89.4% vs. 73.1%).
PreHevbrio is expected to be available in the U.S. in the first quarter of 2022, VBI Vaccines said.
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