FDA does U-turn, will review Moderna's mRNA flu shot after shocking rejection

February 19, 2026
FDA does U-turn, will review Moderna's mRNA flu shot after shocking rejection

Here's something that caught my attention — the FDA did a complete 180 on Moderna’s mRNA flu vaccine. Just last week, they shockingly refused to even review it, a move that seemed driven more by politics than science, according to Beth Mole writing in Technology. The decision was made by Vinay Prasad, a Trump-era appointee, who overruled agency scientists and a top official, which raised eyebrows across the industry. But here’s where it gets interesting: Moderna didn’t just give up. They held a formal meeting with the FDA, proposed a new way to navigate the approval process, and now, the agency has agreed to review their vaccine. That’s a big shift, especially after such a controversial rejection. As Beth Mole reports, this turnaround shows how regulatory paths can still change — especially when companies push back with new data and proposals. So, keep an eye — this could set a new precedent for vaccine approvals moving forward.

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.

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Audio Transcript

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.

Read full article

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