Moderna says FDA refuses to review its application for experimental flu shot

[douglas9]

The Food and Drug Administration has refused to start a review of Moderna’s application for its experimental flu shot, the company announced Tuesday, in another sign of the Trump administration’s influence on tightening vaccine regulations in the U.S.

The company’s stock fell roughly 7% in after-hours trading Tuesday.

Moderna said the move is inconsistent with previous feedback from the agency from before it submitted the application and started phase three trials on the shot, called mRNA-1010. The drugmaker said it has requested a meeting with the FDA to “understand the path forward.”

Moderna noted that the agency did not identify any specific safety or efficacy issues with the vaccine, but instead objected to the study design, despite previously approving it. The company added that the move won’t impact its 2026 financial guidance.

Moderna’s jab showed positive phase three data last year, meeting all of the trial goals. At the time, Moderna said the stand-alone flu shot was key to its efforts to advance a combination vaccine targeting both influenza and Covid-19.

The announcement follows sweeping changes to U.S. immunization policy over the past year under Health and Human Services Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic.

https://www.cnbc.com/2026/02/10/moderna-fda-flu-shot.html

[303squadron]

1. Knuckledragging Democracy Y'all

“My right to reject science over rules your right to be alive.”

[LetMyPeopleVote]

2. MaddowBlog-FDA's refusal to review Moderna flu vaccine generates immediate political backlash

While the Trump administration focuses on a deworming medication as a possible cancer cure, it’s taking a different approach to a potential flu vaccine.

FDA’s refusal to review Moderna flu vaccine generates immediate political backlash While the Trump administration focuses on a deworming medication as a possible cancer cure, it’s taking a diff...

#Maddowblog #Politics

Origin | Interest | Match

— Cancer-Vaccine (@cancer-vaccine.activitypub.awakari.com.ap.brid.gy) 2026-02-11T14:55:00.000Z

https://www.ms.now/rachel-maddow-show/maddowblog/fdas-refusal-to-review-moderna-flu-vaccine-generates-immediate-political-backlash

It was almost five years ago that the Food and Drug Administration published a curious missive to social media, which may have left some people confused. “You are not a horse,” the FDA said in a now-deleted tweet. “You are not a cow. Seriously, y’all. Stop it.”

Ordinarily, the FDA wouldn’t have to remind people that they’re not livestock, but it became necessary for an unfortunate reason: An alarming number of people were trying to treat Covid-19 by voluntarily taking a medicine known as ivermectin, which is generally a deworming medication intended for horses and cows.....

Making matters spectacularly worse, while the Trump administration takes seriously the idea that a livestock deworming medication might cure cancer, the same administration is taking a very different approach to a potential vaccine for influenza. The New York Times reported:

The vaccine maker Moderna said on Tuesday that the Food and Drug Administration had notified the company that the agency would not review its mRNA flu vaccine, the latest sign of federal health policy that has become hostile to vaccine development.

Dr. Vinay Prasad, the agency’s top vaccine regulator, rejected the company’s application for approval over a concern that Moderna’s clinical trial had compared its experimental vaccine against a product the agency did not consider the best on the market. People in the comparison group received Fluarix Quadrivalent, a flu vaccine sold by GSK.

The Times’ report added that Moderna had spent years and hundreds of millions of dollars testing its flu vaccine. Evidently, the Trump administration doesn’t care.....

Democratic Sen. Patty Murray of Washington wrote online on Tuesday night that Health and Human Services Secretary Robert F. Kennedy Jr. “is now blocking an updated flu vaccine for no reason grounded in science. American vaccine policy has been hijacked by a conspiracy theorist — yet most Republicans are happy to just sit on their hands. They are allowing FDA policy to be dictated by DELUSION.”

Murray, in a message directed at Republican Sen. Bill Cassidy of Louisiana, who chairs the Senate’s Health, Education, Labor and Pensions Committee, added, “If I were the Chair of the Senate HELP Committee, I would have moved to subpoena RFK Jr. a LONG time ago, but the next best time is NOW. [Cassidy], what happened to those quarterly oversight hearings? You and I both know it’s well past time for Congress to step in.”

Cassidy has not yet responded. Watch this space

[LetMyPeopleVote]

3. Recommend FDA reverses course, will review Moderna's mRNA flu vaccine

Moderna revised its application following the FDA's surprise decision to not review the flu shot.

A bit of good news this morning: FDA reverses course, will review Moderna's mRNA flu vaccine

www.nbcnews.com/health/healt...

— Laura Haynes👩‍🔬⚾️🐾💙 (@drlaurahaynes.bsky.social) 2026-02-18T14:13:46.545Z

https://www.nbcnews.com/health/health-news/fda-reverses-course-will-review-modernas-mrna-flu-vaccine-rcna259531

Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modifications.

The reversal, which comes just a week after the FDA’s surprise decision to not review the company’s experimental flu vaccine application, lifted shares of the vaccine maker more than 3% before the bell.

The FDA has accepted Moderna’s revised approach seeking full approval for the shot for adults aged between 50 and 64, and accelerated approval for those aged 65 and above, the company said, adding that it will also conduct a post-marketing study in older adults.

The mRNA technology used in Moderna’s and most other Covid shots, credited with saving millions of lives, comes with a shift in the national health policy under Health Secretary Robert F. Kennedy Jr., a long-time anti-vaccine activist who has been particularly critical of mRNA vaccines.

The regulator had defended its initial decision, saying the company should have given a higher-strength vaccine to older patients in the control arm of its trial.