New Type of Hepatitis B Vaccine OK'd

 The FDA approved the first three-antigen hepatitis B vaccine (PreHevbrio) to prevent infection from all known subtypes in adults, VBI Vaccines announced on Wednesday.

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

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

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

"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 three-antigen hepatitis B vaccine," said Chari Cohen, DrPH, MPH, of the Hepatitis B Foundation, in a statement from VBI Vaccines's announcement.

"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.," she added.

The PreHevbrio vaccine series involves 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 within the first quarter of 2022.

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

Common adverse events with the three-antigen vaccine include injection site pain and tenderness, as well as systemic reactions such as fatigue, headache, and myalgia, "all which generally resolved without intervention in 1-2 days," VBI Vaccines stated.

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

https://www.medpagetoday.com/gastroenterology/hepatitis/95983