Another instance of a center director acting unilaterally to overrule other staff (which here also involved ignoring FDA's previous statements to the company).
As @reshmagar.bsky.social and I have argued, the bar should be much higher for such unilateral action:
www.nature.com/articles/s41...
The US Food and Drug Administration (FDA) is at a crossroads. There is an urgent need to strengthen the integrity of drug approvals and rejections by diffusing the decision-making authority of individ...
BREAKING: @lizzylawrence.bsky.social reports that CBER director Vinay Prasad overruled career #FDA staff and unilaterally decided to refusal to accept #Moderna 's #flu vaccine submission. www.statnews.com/2026/02/11/m...
The rejection is the latest instance of Vinay Prasad overruling career FDA scientists to place vaccines under harsher scrutiny.
ICYMI: #FDA has refused to review #Moderna's mRNA #flu vaccine licensure application, suggesting the company should have used a different comparator vaccine in its Phase 3 clinical trial. Moderna suggests the regulatory agency moved the goalpost. www.statnews.com/2026/02/10/f...
Helen Branswell 🇨🇦
www.statnews.com
FDA refuses to review Moderna’s influenza vaccine, which could raise concerns about the agency’s posture toward vaccines and drug approvals more generally.
