New type of hepatitis B vaccine OK

The FDA has approved the first three-antigen hepatitis B vaccine (PreHevbrio) to prevent infection with all known subtypes in adults, VBI vaccines announced wednesday.

Approval of the recombinant vaccine – which contains the hepatitis B virus (HBV) S, pre-S1 and pre-S2 surface antigens – was based on data from two Phase III trials that compared safety and immunogenicity relative to the single antigen Engerix-B vaccine.

In PROTECT, the three-antigen vaccine demonstrated higher rates of seroprotection compared to Engerix-B in all adults (91% vs. 77%, respectively) and in those 45 years and older (89% vs. 73%). In CONSTANT, a pooled analysis of adults who received PreHevbrio had numerically higher seroprotection rates than those in the Engerix-B group (99% vs. 95%).

Last month, the Advisory Committee on Immunization Practices (ACIP) recommended that all adults aged 59 and under, and adults aged 60 and over who have risk factors for HBV, be vaccinated. against HBV.

“As we work to implement ACIP’s new universal hepatitis B vaccine recommendation for all adults aged 19 to 59, as voted in November, we benefit from more tools. , including this newly approved three-antigen hepatitis B vaccine, ”said Chari Cohen. , DrPH, MPH, of the Hepatitis B Foundation, in a news release from VBI Vaccines.

“Having more vaccine options will help us effectively scale up immunization, ensure more people are protected against hepatitis B infection, and meet the 2030 goal of eliminating hepatitis B in the United States, ”she added.

The PreHevbrio vaccine series consists of three intramuscular injections, with the second and third doses given at 1 and 6 months. Single-dose vials (1.0 ml) of the product are expected to be available in the first quarter of 2022.

According to the label, the vaccine is contraindicated in patients with a history of anaphylaxis after previously receiving a HBV vaccine.

Common adverse events with the tri-antigen vaccine include pain and tenderness at the injection site, as well as systemic reactions such as fatigue, headache, and myalgia, “all of which usually resolved without intervention by. 1 to 2 days, “VBI Vaccines said.

Immunocompromised patients may have a diminished response, and adults with an unrecognized HBV infection at the time of receiving the vaccine may not be protected, the company noted.

  • Zaina Hamza is a writer for MedPage Today, covering gastroenterology and infectious diseases. She is based in Chicago.

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