FDA refuses to review Moderna's influenza vaccine

[lostincalifornia]

The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines.

Moderna, revealing the rejection, took the unusual step of releasing the letter it had received from Vinay Prasad, who heads the FDA’s biologics division. It also issued a strongly worded statement from its CEO Stéphane Bancel, who said the decision “does not further our shared goal of enhancing America’s leadership in developing innovative medicines.”

At the heart of the dispute is what existing influenza vaccine Moderna should have used as a control when testing the efficacy of its new shot, which utilizes the same mRNA technology the company used in its Covid-19 vaccine.

In the “refusal-to-file” letter, Prasad wrote that the FDA does not consider the study in the application to be “adequate and well-controlled” — the standard for FDA approval under the law — because “your control arm does not reflect the best-available standard of care in the United States at the time of the study.” He added: “I note that this determination is consistent with FDA’s advice given to you prior to your study.”

https://www.statnews.com/2026/02/10/fda-refuses-review-moderna-flu-vaccine-application/

[Mysterian]

1. What the actual fuck?

[GreenWave]

2. Fred Trump wanted us to die from plagues, etc. Now sonny boy is leading the effort.

[LetMyPeopleVote]

3. 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.