FDA Advisory Panel Votes in Support of 2-Dose Hep B Vaccine

July 28th, 2017:

The US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee voted 12-1 in favor of recommending the Dynavax 2-dose Hep B vaccine, Heplisav-B, for licensing in adults aged 18 years and older.

While trials have shown Heplisav-B to be effective, its safety profile is still under evaluation.

Hepsilav-B has been praised for its shorter schedule: instead of three doses given over 6 months, as is the practice with current rival products, Hepsilav-B is given in two doses over 1 month. This shorter schedule is important because it increases the likelihood that more individuals will receive the full dose schedule and therefore the full protection offered by the vaccine.

While advisory panel recommendation does not assure the FDA will approve the vaccine, it typically does result in approval. The FDA is expected to make its decision regarding the approval of Heplisav-B this August.

Click to read more on the clinical trials of Hepsilav-B, the potential impact of Hepsilav-B approval, and Dynavax’s press release following the vote.

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