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VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot

VBI Vaccines Gets FDA Approval for First Three-Antigen Hepatitis B Shot

VBI Vaccines got its first vaccine approval from the US Food and Drug Administration (FDA) for its hepatitis B shot PreHevbrio. PreHevbrio is approved for the prevention of hepatitis B infection caused by the hepatitis B virus (HBV) in adults 18 years of age and older.

The approval is the first for Massachusetts-based VBI Vaccines, a biopharmaceutical company focused on leveraging immunology “in the pursuit of powerful prevention and treatment of disease,” according to the company’s mission statement.

And in another first, VBI’s shot is the only approved three-antigen HBV vaccine for adults in the US. PreHevbrio contains the S, pre-S2 and pre-S1 HBV surface antigens.

The approval comes at the onset of an expected expansion of the hepatitis B vaccine market, especially after an advisory committee to the Centers for Disease Control and Prevention (CDC) endorsed hepatitis B vaccination for adults 19 to 59 years of age. The current guidance from the CDC is that adults may get the vaccine while high-risk individuals should get it.

PreHevbrio will be joining a couple of other shots in the hepatitis B vaccine arena, including Dynavax’s Heplisav-B, GlaxoSmithKline’s Engerix-B and Merck’s Recombivax HB. PreHevbrio is the only three-antigen vaccine among the group.


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Hepatitis B has infected more than 295 million individuals worldwide and it is estimated that 80,000 Americans will newly acquire the infection each year. According to the World Health Organization (WHO), hepatitis B led to 820,000 deaths in 2019, with most caused by cirrhosis, liver decompensation and hepatocellular carcinoma. HBV is the leading cause of liver disease and is difficult to cure with current treatments, with many patients going on to develop liver cancers.

The WHO has the goal of eradicating hepatitis B globally by 2030 under its Sustainable Development Agenda.

The FDA approval for VBI Vaccines’ hepatitis B shot was based on data from two pivotal Phase III studies, PROTECT and CONSTANT, results of which were published in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021, respectively. Both trials evaluated the efficacy of PreHevbrio against the monovalent (single antigen) Engerix-B. Results from the PROJECT study showed that PreHevbrio offered higher seroprotection rates compared with Engerix-B in individuals 18 years of age and older (91 percent vs. 76 percent) and 45 years of age and older (89 percent vs. 73 percent). The shot demonstrated a good safety profile with no unexpected reactions.

Prior to the FDA approval, PreHevbrio was only approved in Israel.

Awareness of the disease is low, which results in it often going undiagnosed. It is estimated that 32 percent of adults with chronic infection are not aware of their infection status. Moreover, rates of vaccination among adults 19 and older remain low at around 25 percent.

Hepatitis vaccination campaigns for children have helped bring hepatitis B infection rates down in kids. The WHO estimates that in 2019, the proportion of children under five years of age with chronic hepatitis B infection fell to under one percent from around five percent in the pre-vaccine era of the 1980s to the early 2000s.

VBI Vaccines now awaits the green light from the Advisory Committee on Immunization Practices (ACIP), whose job is to provide specific recommendations for the use of FDA-approved vaccines.

VBI Vaccines says it expects PreHevbrio to be available some time in the first quarter of 2022. The company has been in partnership with Syneos Health for the past two years to help prepare for commercialization.

The global hepatitis B vaccine market is expected to grow at a compound annual growth rate (CAGR) of 5.8 percent from 2019 to 2026 and hit a market value of $2.13 billion by 2026.