New 2-dose adult HBV vaccine FDA approved
Algolia Search
Schedule Telemedicine Consult with Dr. Gish Powered byTelemed2U
Powered byTelemed2U

New 2-dose adult HBV vaccine FDA approved

The FDA today approved HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] – the first new hepatitis B vaccine in more than 25 years and the only two-dose regimen for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Hepatitis B is a potentially deadly virus that is 50 to 100 times more infectious than HIV[i] – and infections are on the rise. There is no cure, but hepatitis B can be prevented through effective vaccination. Current hepatitis B vaccines require three shots over a six-month period, however, almost half of adults fail to complete the series within one year.

The approval of HEPLISAV-B was based on data from three Phase 3 non-inferiority trials, showing that HEPLISAV-B (two doses over one month) delivered higher rates of protection compared to Engerix-B (three doses over six-months). Across the three clinical trials for HEPLISAV-B, the most common local reaction was injection site pain (23% to 39%). The most common systemic reactions were fatigue (11% to 17%) and headache (8% to 17%).

Please share through your networks! Sample content for website or newsletters and sample posts for Twitter and Facebook

Thank you in advance for your support and partnership in raising awareness of this significant milestone. Please let us know if you have any questions.

See Full Prescribing Info for important safety information.