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FDA declines to review Moderna's mRNA flu shot
- schiffern 8mo agohttps://archive.ph/sGvJW https://archive.ph/sGvJW
- panny 8mo ago[flagged]
- yCombLinks 8mo agoGood how?
- cbeach 8mo ago[flagged]
- kelseyfrog 8mo agoNot an RCT, and no mention of it's clinical significance. Call me back when it's clinically significant. This feels like a psy-op to read through.
- cbeach 8mo agohttps://pubmed.ncbi.nlm.nih.gov/34614328/ https://pubmed.ncbi.nlm.nih.gov/34614328/ Large, real-world, nationwide context: ~5.1 million people in Israel were fully vaccinated with Pfizer (BNT162b2) in the study period. Active surveillance triggered by safety signals (not just “whoever bothered to report a symptom”). Clinical case adjudication using a standard definition (Brighton Collaboration criteria), which reduces “anything chest-related = myocarditis” noise. Published in NEJM, which is about as top-shelf as clinical journals get. What clinically significant side effect does it show? Myocarditis (inflammation of the heart muscle), which is clinically significant because it can involve emergency presentation (chest pain, shortness of breath), abnormal cardiac biomarkers / ECG / imaging and hospital admission (this study reviewed diagnosed cases in that system). > Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.
- kelseyfrog 8mo agoAgain. Not an RCT. Not clinically significant. Keep trying.
- clumsysmurf 8mo agoUnfortunate, just recently I read "Influenza vaccination is associated with significantly lower odds of myocardial infarction (MI), according to a large meta-analysis published late last week in BMC Public Health." https://www.cidrap.umn.edu/influenza-vaccines/new-analysis-links-flu-vaccination-18-lower-odds-heart-attack https://www.cidrap.umn.edu/influenza-vaccines/new-analysis-l...
- ottah 8mo agoWe will still have flu vaccines, just not this vaccine.
- altcognito 8mo agoThe question isn't whether or not we have vaccines, it is whether or not we have the most effective vaccines.
- alex43578 8mo agoIt’s a good thing the specific criticism of this trial is that they didn’t use the most effective vaccine for 65+ people, since you’re concerned about having the most effective vaccines.
- watwut 8mo agoSo, the majority of us, people under 65 are completely unaffected. And yes, the vaccine can be approved for 65- while not approved for 65+.
- alex43578 8mo agoThe fall 2025 approval was limited to 65+/preexisting conditions. If this vaccine wasn’t being tested for 65+, it might not be approved at all based on that.
- altcognito 8mo ago
- AIorNot 8mo agoyes, lets find more ways to kill people besides bringing back the measles. God what a race to the bottom for this administration..
- dham 8mo agoTo be fair, a lot of doctors were sounding the alarm in 2021 that forcing the Covid shot was going to cause blow back. They said word for word, that we might see the rise of measles and other similar diseases. It's actually very well documented on zdoggmd youtube channel (podcast) during this time. But there were tons of doctors saying the same thing.
- jleyank 8mo agoBecause the docs knew that far too many people would rather face risk to avoid doing what they’re told to do. And far too many people just don’t give a shit about other people. The npc’s aren’t real or pertinent.
- _m_p 8mo agoHow did taking it benefit other people?
- t-writescode 8mo agoThe best way to keep immunocompromised and people who literally can’t take vaccines safe is by having so much herd immunity that the likelihood they a virulent load of a virus cannot get to those people. A great way to get herd immunity is through mass vaccination.
- alex43578 8mo agoExcept herd immunity for COVID isn’t feasible or even possible. It mutates too much, the vaccines don’t confer effective enough immunity, etc. It’s unfortunate, but it’s the reality of this disease. I’m not immunocompromised, but I still modify my behavior to try and protect myself: mask on planes, avoid certain situations, etc.
- jaybrendansmith 8mo agoThis technology is going to cure cancer someday. Too bad we won't get to use it. The FDA just killed 'future you'.
- smt88 8mo agoI can't find a specific source right now, but I remember reading that RFK's war on mRNA vaccines only applies the ones used for flu/Covid. They haven't gone after cancer vaccines. This press release seems to confirm this: https://biontechse.gcs-web.com/news-releases/news-release-details/biontech-receives-fda-fast-track-designation-mrna-cancer https://biontechse.gcs-web.com/news-releases/news-release-de...
- _DeadFred_ 8mo ago"Moderna curbing investments in vaccine trials due to US backlash, CEO tells Bloomberg TV" https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-curbing-investments-vaccine-trials-due-us-backlash-ceo-tells-bloomberg-2026-01-22/ https://www.reuters.com/business/healthcare-pharmaceuticals/...
- smt88 8mo agoThose are for immunization against viruses. They're not the same kind of vaccine that will be used to cure many types of cancer.
- jaybrendansmith 8mo agoSo we should feel better about this? And watch as Europe gets better vaccines? Apparently COVID and Flu vaccines have many health benefits. https://medicalxpress.com/news/2026-02-analysis-links-flu-vaccination-odds.html https://medicalxpress.com/news/2026-02-analysis-links-flu-va...
- fnordpiglet 8mo agoFuture me would have a really high quality EV with an amazing charging network, clean air and water, a habitable planet for my grand children, no domestic political extrajudicial paramilitary surveilling everyone with megawarehouse detention cities everywhere, outright ideological warfare against urban areas, etc. We had a choice between Star Trek future world and Blade Runner+MadMax+Idiocracy, and we predictably chose the one we deserve because memes and a podcast.
- Domenic_S 8mo ago[flagged]
- sephamorr 8mo agoExcept this is not how medical regulation has worked in the US. This particularly is a new and stricter standard required for this particular vaccine. Even the new Trump policies for COVID vaccines now specifically requires a placebo -- comparison against standard-of-care would not be accepted.
- Domenic_S 8mo agoHuh? The FDA's main guidance document on this topic, issued in 2007 with no major overhaul since [0], states that comparative efficacy or effectiveness data is valuable when: - The comparator vaccine is indicated for the same population. - The comparator has existing clinical effectiveness data. In other words, the trial design should use a benchmark that makes sense given what doctors and guidelines actually recommend today. For older adults, evidence over the past 15+ years has shown that enhanced flu vaccines often provide better protection than standard-dose ones. The study used standard-dose vaccines as far as we can see. The only oddity here is that the FDA apparently approved the study previously [0] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-data-needed-support-licensure-seasonal-inactivated-influenza-vaccines https://www.fda.gov/regulatory-information/search-fda-guidan...
- sephamorr 8mo agoThe document describes proof of effectiveness as supported by demonstrating "non inferiority to... a US licensed product". So yes, a (licensed) benchmark, but I see no references to a requirement for only testing against the best standard of care. It's a separate question about whether it should be though, and the cfr is quite vague throughout, so I would probably expect this isn't an illegal move (assuming arbitrary and capricious isn't held by a court), but I don't see it supported by precedent.
- intermerda 8mo ago
- cosmicgadget 8mo 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 8mo 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 8mo agoIs sandbagging like this normal in getting FDA approvals or did someone at Moderna f this up?
- icegreentea2 8mo 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 8mo agoThat was 2024. I wonder what could possibly be different about today, in 2026?
- smt88 8mo ago
- rolph 8mo agocurrently endorsed production technology is not responsive enough to produce an effective vaccine in time for unexpected viral antigen shift. we need to cut the required lead time down to weeks, rather than months. we also need to stand up a surveilance network again.
- xiphias2 8mo agoWhat's crazy here is that FDA finally has a great head who actually tries to speed things up using Bayesian data modeling and understands drugs quite well (Marty Makary) and does everything to make drug approval process cheaper and more efficient without compromising safety. Unfortunately it seems like this decision was overwritten by his boss for political a win.
- nielsbot 8mo ago> Unfortunately it seems like this decision was overwritten by his boss for political a win. I think RFK is actually mentally damaged. He's been on his "do your own research" anti-vax crusade forever.
- kelipso 8mo ago[flagged]
- archagon 8mo agoUnfortunately, “do your own research” is de facto shorthand for “I reject your reality and substitute my own.”
- ifyoubuildit 8mo agoThere's a good standup bit out there: we used to have a word for "doing your own research": reading! Now everyone gives you shit for it.
- archagon 8mo agoReading is worthless if you don't vet your sources. Encyclopedia Britannica and Uncle Johnny's Chemtrail Digest are not equally valid sources of truth.
- ifyoubuildit 8mo ago