FDA Approves First 2-Dose Hepatitis B Vaccine

NOVEMBER 10, 2017
Officials with the FDA have approved an adjuvanted hepatitis B vaccine, recombinant  [Heplisav-B, Dynavax]  for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. Heplisav-B is the first and only 2-dose hepatitis B vaccine for adults approved in the United States.

Heplisav-B combines hepatitis B surface antigen with toll-like Receptor (TLF) 9 agonist to enhance immune response.

The approval is based on data from 3 phase 3 non-inferiority trials of nearly 10,000 adult participants who received the vaccine. Heplisav-B was administered in 2 doses over a 1-month period and compared with Engerix-B, which was administered in 3 doses over a 6-month schedule. In the largest phase 3 trial, which included 6,665 participants, Heplisav-B demonstrated a statistically significantly higher rate of protection of 95% compared with 81% for Engerix-B.

In a subgroup analysis of 961 participants with type 2 diabetes, Heplisav-B demonstrated a statistically significantly higher rate of protection of 90% compared to 65^ for Engerix-B. The most common adverse effects reported were injection site pain (23-39%), fatigue (11-17%), and headache (8-17%).

Dynavax expects Heplisav-B to be available in the United States in 2018.

Dynavax announces FDA approval of HEPLISAV-B(TM) for prevention of hepatitis B in adults [news release]. Berkley. Dynavax’s website. http://investors.dynavax.com/releasedetail.cfm?ReleaseID=1048181. Accessed November 10, 2017.


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