VBI Vaccines scores first FDA vaccine nod just as the hepatitis B market is set to expand - FiercePharma

VBI Vaccines has toiled a while to earn its first FDA approval. But for the Massachusetts-based company, the timing may be perfect.

In gaining a green light for its hepatitis B shot, VBI is poised to take advantage of what figures to be a growing market. A month ago, a CDC advisory committee voted unanimously to strengthen its recommendation for hepatitis B vaccination, saying that those aged 19 to 59 "should" receive shots. The current guidance for adults is that they "may" get the vaccine and only those deemed at risk "should" receive it.

With the FDA blessing, PreHevbrio joins three other hepatitis B shots on the market—Dynavax's Heplisav-B, GlaxoSmithKline's Engerix-B and Merck's Recombivax HB.

Already approved in Israel, PreHevbrio is differentiated from the others as a three-antigen vaccine. In a head-to-head phase 3 trial, PreHevbrio provided higher seroprotection than the monovalent Engerix-B.

"The feedback we're getting is that this is clearly a highly effective vaccine, which is safe and well-tolerated," VBI CEO Jeff Baxter said during an investor's call. "And particularly, statistically, significantly, we are better in adults age 45 and over."

The next order of business for VBI will be to receive endorsement from the Advisory Committee on Immunization Practices.

"Just getting that recommendation alongside (the others) is a very important first step," Baxter said. "That creates a level playing field for PreHevbrio to compete against those vaccines."

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Baxter expects a nod from the ACIP to come before the end of the first quarter of 2022, provided that COVID variants don't "hijack" the work of the committee, he said.

The FDA based its approval on two phase 3 studies showing PreHevbrio elicited higher rates of seroprotection compared with Engerix-B in subjects age 18 and older (91% vs. 76%) and 45 and older (89% vs. 73%). The safety analysis of both studies demonstrated good tolerability with no unexpected reactions.

Hepatitis B has infected more than 290 million people globally. HBV is the leading cause of liver disease and, with current treatments, is difficult to cure. Many patients go on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

Low awareness of HBV leads to increased risk of transmission, with 68% of chronically infected adults unaware of their infection status. With adult vaccination rates remaining persistently low at around 25% for adults 19 and older, approximately 200 million adults are left unprotected.

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The World Health Organization has established a goal of eliminating HBV by 2030.

Baxter said he expects the recommendation from the CDC will expand the market from $320 million per year in the United States to more than $500 million a year, with Europe and China likely to follow.

"We could be launching into a very hot market for the next several years," Baxter said.