February 12, 2026
Flu shot or flu flop?
I Regret to Inform You That the FDA Is FDAing Again
FDA blocks Moderna’s new flu shot and the internet absolutely loses it
TLDR: The FDA refused to even review Moderna’s new mRNA flu shot, saying the big trial used the wrong comparison, and now other countries may get it while the U.S. waits. Commenters are raging over politics, anti‑vaccine vibes, and whether America just told drug makers the game is hopelessly rigged.
The FDA just told Moderna “nope” on its shiny new mRNA flu shot, and the comment section is treating it like a full-blown government soap opera. The agency didn’t even review the application, basically saying the billion‑dollar trial used the wrong comparison vaccine. To normal humans, that’s like being told your exam doesn’t count because you used the wrong kind of pencil — after the teacher approved it.
One camp is furious at what they see as anti‑vaccine politics from a new administration that’s flirting with vaccine skeptics. One commenter says RFK Jr.’s anti‑vax crowd could “kill more people than Idi Amin,” pointing out that vaccines save millions of lives a year, linking straight to the CDC. Another group is focused on business drama: why would any pharma CEO invest in U.S. trials if the rules change after the money’s spent, they ask, calling the U.S. market a rigged casino.
Then come the dark jokes. People are snarking that Europe, Canada, and Australia will get the fancy new flu shot while America argues over which control group was “vibes compliant.” Others drag both the current and previous administrations, arguing that no matter who’s in charge, the FDA keeps “FDAing” — slowing things down, moving the goalposts, and turning life‑saving tech into political theater.
Key Points
- •The FDA issued a Refusal-to-File letter for Moderna’s mRNA-1010 influenza vaccine application.
- •The FDA’s stated reason was Moderna’s use of a standard-dose comparator instead of an enhanced, ACIP-preferred comparator for adults 65+.
- •The article says Moderna ran large Phase 3 trials (over 43,000 participants) and claims prior FDA alignment on the trial design in April 2024 and indications in August 2025 that filing would proceed.
- •Moderna provided separate Phase 3 immunogenicity and safety data in seniors comparing mRNA-1010 to a licensed high-dose flu vaccine, yet the filing was still refused.
- •Regulators in the EU, Canada, and Australia have accepted Moderna’s application for review, according to the article.