Clean Observer
‪@hammbear2024.bsky.social‬

This isn’t a setback. This is deliberately thwarting the research and development of safe and effective medicine.

‪CNN‬
‪@cnn.com‬
· 5h

The FDA has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said, in another setback for the technology that’s been a target of some Trump administration health officials.
https://www.cnn.com/2026/02/10/health/fda-moderna-mrna-flu-vaccine

6:46 PM · Feb 10, 2026

CNN
‪@cnn.com‬

The FDA has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said, in another setback for the technology that’s been a target of some Trump administration health officials.
https://www.cnn.com/2026/02/10/health/fda-moderna-mrna-flu-vaccine

6:19 PM · Feb 10, 2026

Health • 4 min read
FDA refuses to review Moderna’s application for mRNA flu vaccine, company says

By Meg Tirrell
Updated 2 hr ago
Updated Feb 10, 2026, 9:24 PM ET
PUBLISHED Feb 10, 2026, 6:06 PM ET

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology that’s been a target of some Trump administration health officials.

The agency told Moderna that its application didn’t contain an “adequate and well-controlled” trial because the control arm didn’t reflect the “best-available standard of care in the United States at the time of the study,” according to a letter dated February 3 that Moderna posted online. It didn’t identify any safety or efficacy concerns, the company said.

Moderna said that the refusal was inconsistent with previous feedback from the agency and that it had requested a meeting with FDA officials to understand how to proceed. ... “The complete stunner here is at no point in any of this did anybody say that it was not adequate” to run its clinical trial the way it had discussed with the agency, Moderna’s president, Dr. Stephen Hoge, told CNN on Tuesday. ... The US Department of Health and Human Services said “the FDA generally does not comment on regulatory communications to individual sponsors.” It’s rare for the FDA to issue a “refuse-to-file” letter; a 2021 study of almost 2,500 applications submitted to the agency found that only 4% received such letters.

Moderna used a standard-dose seasonal flu vaccine called Fluarix as a comparator in a 40,700-person clinical trial to demonstrate the experimental mRNA vaccine’s safety and efficacy. The company said the FDA had agreed with that plan in April 2024 but suggested it also include data comparing its vaccine with an approved high-dose flu vaccine for people over 65, which the company said it did.

{snip}