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Data supports safety of Dynavax hepatitis B vaccine: U.S. FDA panel

(Reuters) - Available data supports the safety of Dynavax Technologies Corp's experimental hepatitis B vaccine when administered to adults, a panel of expert advisers to the U.S. Food and Drug Administration said on Friday.

Much of the panel discussion focused on the need for Dynavax to carefully track patient outcomes due to concerns about safety of the vaccine, which has been rejected twice before by the regulatory agency.

The advisory committee voted 12 to 1, including one emailed vote and three abstentions, that data supports the safety of the vaccine, Heplisav-B, for adults 18 years and older. A prior panel voted 13 to 1 that clinical...


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