FDA Denies Approval For Updated COVID Vaccine

NBC News reports:

The Food and Drug Administration confirmed Monday it was requiring drugmaker Novavax to run another clinical trial as part of the approval process for its Covid vaccine, which has been available under emergency use authorization since 2022. Dr. Marty Makary, the FDA’s commissioner, said the company is asking the agency to approve “a new product” based on old data.

Novavax’s shot uses traditional protein-based vaccine technology and is the only alternative to the mRNA shots from Pfizer and Moderna. The drugmaker’s application to the FDA was based on a 30,000-person randomized clinical trial conducted in 2021 in the U.S. and Mexico.

The agency missed an April 1 deadline decision, prompting concerns among investors that it wouldn’t be approved. Dr. Tracy Beth Høeg, who was announced as a special adviser to Makary earlier this month, has called for more scrutiny of vaccines, telling FDA staff and high-ranking officials in a meeting outlining priorities that the agency would be doing fewer vaccine approvals going forward.

Read the full article. Makary, you may recall, appeared on Fox News multiple times during the pandemic to advocate for herd immunity, saying that if everybody would just get COVID, perhaps deliberately, then vaccines wouldn’t be needed. Such a position, of course, ignores that viruses quickly mutate.