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Postmarketing Surprise Is Latest Plot Twist For Novavax’s COVID-19 Vaccine BLA

 
• By Bridget Silverman

Three weeks after its user fee goal date, the FDA demanded a postmarketing commitment “to generate additional data,” Novavax said.

After delays, Novavax hopes the FDA is signaling a path to approval for its COVID-19 vaccine. (Shutterstock)
Key Takeaways
  • Weeks after the user fee goal date, the FDA asked Novavax to submit a postmarketing commitment to generate additional clinical data on its COVID-19 vaccine.
  • Top level political officials at the FDA delayed a decision on Novavax’s COVID-19 vaccine biologics license application.
  • Postmarketing commitments for the two approved COVID-19 vaccines focus on pregnancy safety and real-world effectiveness.

The US Food and Drug Administration has requested an unusual last-minute postmarketing commitment from

“We have recently received formal communication from the FDA in the form of an information request for a postmarketing commitment (PMC) to generate additional clinical data,” Novavax said on 23 April, but did not provide more detail

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