Dynavax shares slide as FDA review spotlights a hazy safety issue for Heplisav
About 8 months after the FDA rejected Dynavax’s hep B vaccine Heplisav, the biotech is once again under scrutiny at the agency.
And one more time, FDA reviewers are zeroing in on the vaccine’s safety profile as it preps another marketing decision for this long-delayed effort.
Last November the FDA said it wasn’t able to properly assess additional details on the adverse events — particularly an imbalance in the cardiac events that regulators were fretting over. In an internal review ahead of Friday’s panel discussion on Heplisav, regulators say that while it is clear that there is an imbalance in deaths and cardiac events, the number they’re talking about is small and hard to read.
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