BURSTThe 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.