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