Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel

 
• By Michael Cipriano
  
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Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.

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Dynavax likely won't have as smooth sailing at its advisory committee for Heplisav.

The US FDA is calling on its Vaccines and Related Biological Products Committee to weigh in on the causality of a higher rate of deaths and major cardiovascular adverse events among patients taking Dynavax Technologies Corp.'s hepatitis B vaccine Heplisav (rHBsAg-1018 ISS), as well as the adequacy company's proposed postmarketing safety to assess these risks.

The company compared Heplisav to competitor vaccine Engerix-B, manufactured by GlaxoSmithKline PLC over the course of three pivotal trials.

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