Home Virology HBV And Then There Were Four: VBI Scores First FDA Approval with Hepatitis...

And Then There Were Four: VBI Scores First FDA Approval with Hepatitis B Vaccine

Company eyes a market set to expand to $500 million or more after CDC panel recommends universal vaccination for adults 18-59

By Alex Philippidis

December 6, 2021

An electron microscopic image reveals the presence of hepatitis B virus (HBV) particles (shown in orange). The FDA has approved VBI Vaccines’ PreHevbrio™ [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of HBV in adults age 18 years and older. [CDC]

Approval of PreHevbrio came nearly a month after the U.S. Centers for Disease Control (CDC)’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended universal HBV vaccination for all U.S. adults aged 18-59 and for adults age 60+ with risk factors for infection. According to VBI, ACIP’s vote will nearly double the U.S. HBV adult vaccination market over the next five to eight years, to more than $500 million from about $320 million in 2019 . . .