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> In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “co
by cosmicgadget 9mo ago
> In a release Tuesday, Moderna said the FDA did not identify any safety or efficacy concerns with the vaccine. Instead, it said the FDA took issue with the “comparator” in its clinical trial — the vaccine the company used as a benchmark to evaluate its own shot.
> The FDA said the use of the standard flu shot as a comparator “does not reflect the best-available standard of care.”
Are they implying that a placebo should be the comparator?
- icegreentea2 9mo agoNo, they're implying that Moderna should have used a high dose flu vaccine in the >65 age group as the control condition in the efficacy trial. EDIT: To be clear, I'm pretty sure that's just some pretext.
- cosmicgadget 9mo agoIs sandbagging like this normal in getting FDA approvals or did someone at Moderna f this up?
- icegreentea2 9mo agoTrial designs are rarely perfect, and drug companies will try to stack the deck. That being said, trial designs aren't made in isolation without consultation. Moderna's press release about this (https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA https://feeds.issuerdirect.com/news-release.html?newsid=7346...) indicates that 2024 CDC said that performing an efficacy trial without using the higher dose would likely cause complications for recommending the mRNA vaccine for the >65 age group, but would not impact overall approval.
- stouset 9mo agoThat was 2024. I wonder what could possibly be different about today, in 2026?
- smt88 9mo agoThis is specifically a political attempt by RFK Jr. to stop people from getting mRNA flu vaccines.
- carbonatedmilk 9mo agoContext from the CDC guidance from August 2025 (https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm https://www.cdc.gov/mmwr/volumes/74/wr/mm7432a2.htm) "Except for vaccination for adults aged ≥65 years, ACIP makes no preferential recommendation for a specific vaccine when more than one licensed and recommended vaccine is available. Among adults aged ≥65 years any one of the following higher dose or adjuvanted influenza vaccines is preferentially recommended: HD-IIV3, RIV3, or aIIV3. If none of these three vaccines is available at an opportunity for vaccine administration, any other available age-appropriate influenza vaccine should be used (4,5)"
- junofan 9mo agoThere’s a flu shot for old people. It appears Moderna chose not to administer that when appropriate. Maybe technically they aren’t required to. The whole thing sounds messy but who knows.
- bediger4000 9mo agoThat's true some years, but not all. Usually, the difference is over 55 (or whatever) you get a quadrivalent vaccine instead of trivalent. That is, vaccine for the usual strains, plus a 4th. It's not totally different.