The FDA’s request for Novavax to conduct a new clinical trial before granting full approval for its COVID-19 vaccine has sparked uncertainty regarding updates to other vaccines. Novavax stated that the FDA’s demand for a new trial, despite the vaccine being considered “approvable,” raises questions about the approval process for yearly strain updates. A social media post by FDA Commissioner Marty Makary suggested that a new trial might be necessary before yearly updates, potentially delaying approvals until fall. This has led to concerns about whether other vaccines will face similar scrutiny. Experts like Dr. Jesse Goodman argue that treating strain changes as new products could hinder timely vaccine updates. The FDA’s move comes amid broader changes in vaccine policy under Health Secretary Robert F. Kennedy Jr., who has promised to review vaccine schedules. Pfizer and Moderna’s mRNA vaccines have already received full approval for certain age groups, while Novavax remains under emergency use authorization. The FDA’s decision to pause Novavax’s approval process has been criticized as unusual and potentially politically motivated. Experts warn that imposing additional requirements without following established procedures could lead to legal challenges.
— new from AP News
