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FDA Panel Considers Dynavax’s Heplisav Safety Database Insufficient

 
• By Cathy Dombrowski

The sponsor’s proposal for a post-approval cohort safety study in 30,000 patients failed to alleviate the concerns of a majority of the vaccines advisory committee, which voted 8 to 5 with one abstention that available data do not support the safety of the hepatitis B vaccine.

Members of the Vaccines and Related Biological Products Advisory Committee did not find the promise for a 30,000-patient post-market safety study sufficient to assuage their concerns about the risks of approving Dynavax Technologies Corp.’s hepatitis B vaccine Heplisav (rHBsAg-1018 ISS) for the general adult population.

The panel voted 8 to 5 with one abstention that available data do not support the safety of the vaccine in those 18 to 70 years of age; it accepted by 13 to 1 that immunogenicity data submitted with the BLA for Heplisav support the product’s

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