FDA reverses surprise rejection of Moderna's mRNA flu vaccine
The Food and Drug Administration has reversed its shocking refusal to consider Moderna's mRNA flu vaccine for approval.
The refusal was revealed last week in a sharply worded press release from Moderna. Subsequent reporting found that the decision was made by political appointee Vinay Prasad, the Trump administration's top vaccine regulator, who overruled a team of agency scientists and a top career official in rejecting Moderna's application.
In an announcement Wednesday morning, Moderna said the FDA has now agreed to review its vaccine after the company held a formal (Type A) meeting with the FDA and proposed a change to the regulatory pathways used in the application.