FDA appears to be slow-walking vaccine approvals

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by imposing new regulatory hurdles on drugmakers, such as changing the requirements for approval or seeking additional clinical trial data.

Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by imposing new regulatory hurdles on drugmakers, such as changing the requirements for approval or seeking additional clinical trial data. 

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.  

On Saturday, Makary suggested in a post on X that Novavax was seeking approval for a “new” vaccine because the strain used in its trial has since been updated to target a more recent  Covid variant called JN.1.