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%).
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