Dynavax takes a big step toward an OK for hep B vaccine, but nagging safety issues remain
Will the third time prove the charm for Dynavax?
More than a few analysts are still asking that question after a panel of outside experts formed by the FDA offered a lopsided vote in favor of an approval — with three abstentions for its hep B vaccine Heplisav and only one opposed for safety reasons.
Efficacy was never really in doubt. The data are solid. But there was plenty of fretting about Heplisav’s safety profile, after regulators spotlighted an imbalance of deaths and cardiac events which has never been explained. The internal FDA review last Wednesday forced the stock $DVAX down 10%, but it rocketed up 80% Friday evening after the experts weighed in on ways that the biotech could keep a careful eye on the health of the people taking their vaccine.
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