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Dynavax Hep B Vaccine Gets Second Panel Review; Scrutiny On Safety, Superiority

 
• By Brenda Sandburg

After clinical hold, lost partnership and rejection by an advisory committee four years ago, Dynavax will again make its case for approval of Heplisav-B.

Dynavax Technologies Corp. is hoping that new safety and efficacy data for its hepatitis B vaccine Heplisav-B will win over FDA's Vaccines and Related Biological Products Advisory Committee, which voted against the product's approval in 2012.

The committee will review the vaccine candidate for immunization against hepatitis B virus infection in adults ages 18 years and older at its Nov. 16 meeting. The last time around the panel concluded that the available data did not support the safety of the vaccine. Dynavax then had planned a post-market 30,000 patient cohort study to compare Heplisav-B's safety to that of GlaxoSmithKline PLC's Engerix-B but that did not assuage the panel's concerns

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