VBI Vaccines obtains FDA OK for PreHevbrio

The Food and Drug Administration has given VBI Vaccines permission for PreHevbrio [Hepatitis B Vaccine (Recombinant)] for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years old and older.

PreHevbrio contains the S, pre-S2, and pre-S1 HBV surface antigens, and is the only approved 3-antigen HBV vaccine for adults in the U.S.

[Read more: Seqirus receives FDA nod for new Audenz presentation] 

“We are proud to announce the approval of PreHevbrio, VBI’s first FDA-approved vaccine. This is a substantial achievement that demonstrates the VBI team’s ability to progress vaccine candidates from the clinic through to approval. This approval, however, is just the first step in our mission to provide broad access to our vaccine and to help strengthen the public health effort to put an end to adult HBV infections,” Jeff Baxter, VBI’s president and CEO, said. “We would like to thank the study participants, clinical site investigators, our employees, and all who contributed to this achievement, and we look forward to working with public health and advocacy organizations as we join the fight against hepatitis B.”

VBI expects to make PreHevbrio available in the first quarter of 2022 and has partnered with Syneos Health for the past two years to ensure commercial readiness.