FDA refuses to review Moderna's application for mRNA flu vaccine, company says

[mahatmakanejeeves]

Reposted by We Left With All Of My Popehats
https://bsky.app/profile/kenwhite.bsky.social

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

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

— Clean Observer (@hammbear2024.bsky.social) 2026-02-10T23:46:58.337Z

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

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://cnn.it/4kt8iyn

— CNN (@cnn.com) 2026-02-10T23:19:23.9388563Z

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}

[AZJonnie]

1. The regime wants people to die, it could not be more obvious (nt)

[durablend]

6. They've already said they think the country is over populated and need to cut it down

[LudwigPastorius]

2. Bobby Brainworm Jr. wants to kill the elderly.

...and Trump put him in power to do it because, like a true Nazi, he views them as "unnütze Esser".

[BlueWaveNeverEnd]

3. kick

[LetMyPeopleVote]

4. 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

[struggle4progress]

5. "mRNA vaccines strongly magnetize people: many items actually jump onto them from shelves!"

[LetMyPeopleVote]

7. 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.