FDA Misses Deadline For Decision On Novavax’s COVID-19 Vaccine

The Wall Street Journal (4/2, Essley Whyte, Subscription Publication) reports the FDA missed the April 1 deadline to approve Novavax’s COVID-19 vaccine. The agency has permitted emergency use of the vaccine since 2022. Senior agency leaders say more data is needed, signaling that it was unlikely to be approved soon. It would have been the FDA’s first major vaccine approval since Dr. Peter Marks announced his resignation as director of Center for Biologics Evaluation and Research. Reuters (4/2, Satija, Sunny, Erman) reports Marks played a “key role in developing COVID-19 vaccines during U.S. President Donald Trump’s first term.” His departure from CBER “led to a selloff in drugmakers’ stocks on Monday and some analysts said it could put pressure on companies that currently have therapies under regulatory review.” Novavax was disappointed by the news, noting that it had responded to all of the FDA’s information requests as of April 1 and it believes its application is “ready for approval.”