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FDA conclusions on vaccines lack evidence & transparency
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The Infectious Diseases Society of America
FDA conclusions on vaccines lack evidence & transparency
www.idsociety.org/news--pâŚ.
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Infectious Diseases Society of America
Any death is tragic; however, the Food and Drug Administrationâs vague declaration about the COVID-19 vaccine and pediatric deaths undermines confidence in the safety of the vaccine and raises questions about FDAâs own approval process.
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Former FDA commissioners have something to say to Vinay Prasad @statnews.com
The FDAâs planned changes for regulating vaccines represent a threat to effective and available vaccines and public health, according to an article published yesterday in NEJM. But itâs not any old academic critique.
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Glucose monitor problems linked with deaths, injuries: FDA
myfox8.com
Glucose monitor problems linked with deaths, injuries: FDA
The FDA issued an âearly alertâ that some FreeStyle Libre 3 and FreeStyle Libre 3 Plus devices may provide incorrect low glucose readings.
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The FDA is warning people to stop using certain types of glucose monitor sensors after the company that makes them, Abbott Diabetes Care, said the devices were linked to seven deaths and more than 700 injuries.
www.statnews.com/2025/12/âŚ.
www.statnews.com
Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns
The FDA is warning people to stop using certain types of glucose monitor sensors after Abbott Diabetes Care said their devices were linked to seven deaths and more than 700 injuries.
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TOMORROW ON MS NOW: Erielle Reshef interviews FDA Commissioner Dr. Marty Makary â they talk RFK Jr., GLP-1s and more. Don't miss it!
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Pegcetacoplan (Empaveli) reduced proteinuria and helped stabilize kidney function in patients with C3 glomerulopathy or primary immune-complex MPGN, the phase III VALIANT trial found.
www.medpagetoday.com/nephâŚ
www.medpagetoday.com
Here's the Data Supporting Pegcetacoplan's Approval in Two Rare Kidney Diseases
The FDA approved the C3 and C3b inhibitor in July for C3 glomerulopathy and immune-complex MPGN
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âwould undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,â www.cidrap.umn.edu/covid-âŚ.
www.cidrap.umn.edu
Former FDA heads, Sen Cassidy push back on FDA officialâs claim of 10 COVID vaccine deaths
âWe are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available,"...
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An FDA advisory panel gave a unanimous verdict for an interatrial shunt in heart failure: no way.
www.medpagetoday.com/cardâŚ
www.medpagetoday.com
FDA Panel on Interatrial Shunt for Heart Failure: It's a Hard No
Ventura transcatheter device found no support on efficacy at a critical FDA advisory committee
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Trump and Secretary Kennedyâs new vaccine plan is so dangerous 12 former FDA commissioners publicly denounced it.
They are slashing health care while undercutting our best tools to stop people from becoming ill.
It's a *literally* sick Catch-22.
www.washingtonpost.com
A dozen former FDA commissioners condemn plan to tighten vaccine approvals
In the New England Journal of Medicine, the former leaders wrote they were âdeeply concernedâ at how the top vaccine regulator is raising the bar for approvals.
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Before they turned against it, our FDA leaders massively overhyped the vaccine.
Ideology over evidence, every time.
sciencebasedmedicine.org/âŚ.
sciencebasedmedicine.org
Overhyping Vaccines Wasnât Pro-Vaccine. It Was Pro-Stop-Worrying-About-COVID.
Overselling the vaccine in 2021 was not being pro-vaccine. It was pro-stop-worrying-about-the pandemic, from the doctors who assured us herd immunity was imminent.
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Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns
www.seattletimes.com
Faulty glucose monitors linked to 7 deaths and more than 700 injuries, FDA warns
The U.S. Food and Drug Administration warned people to stop using certain types of glucose monitor sensors that were linked to seven deaths.
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BREAKINGđ¨: FDA Approves Liso-Cel for Relapsed/Refractory Marginal Zone Lymphoma #lymsm #oncology www.onclive.com/view/fda-âŚ.
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Former FDA heads, Sen Cassidy push back on FDA officialâs claim of 10 COVID vaccine deaths
âWe are deeply concerned by sweeping new FDA assertions about vaccine safety," write 12 former FDA commissioners, as Cassidy calls for a full briefing
www.cidrap.umn.edu/c...
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If anyone says we "don't have enough evidence" on HepB vaccine safety, that's just wrong.
Our review has found 42 HepB RCTs plus decades of post-licensure monitoring (VAERS, VSD, FDA BEST, big cohort studies).
The problem isn't lack of data, it's ignoring it.
docs.google.com/spreadsheâŚ.
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⥠KFFâs Joel Luther explores how an internal FDA memo that uses unverified vaccine death claims may contribute to confusion about the safety of COVID-19 vaccines for children. #QuickTake on.kff.org/3MkVPzG
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This piece says Makary also gave nonpublic comments to the investment bank. Bank said secrecy was at request of FDA...
Is this typically permitted of gov official - especially one who has lot of market moving info?
Lizzy Lawrence@lizzylawrence.bsky.social
W/ Damian Garde on the ground in NYC: Vinay Prasad, FDAâs vaccine regulator, waves off criticism in closed-door remarks www.statnews.com/2025/12/04/v...
www.statnews.com
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I think that was obvious from the first mention of this claim
endpoints.news/prasads-clai...
endpoints.news
Prasad's claim of 10 Covid vaccine deaths may be an overcount, FDA sources say
The number of Covid-19 vaccine deaths in children under FDA investigation likely will be lower than the 10 deaths initially mentioned in an internal email from CBER director Vinay Prasad, sources fami...
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On this week's #WTHealth podcast: @alicemiranda.bsky.social, @joannekenen.bsky.social, and @paigecunningham.bsky.social on the GOP scramble to find a health plan; vaccine uproar at CDC and FDA, and SCOTUS hears another abortion (related) case...
kffhealthnews.org/news/poâŚ.
kffhealthnews.org
The GOP Still Canât Agree on a Health Plan - KFF Health News
Senate Democrats were promised a vote by mid-December on extending enhanced Affordable Care Act subsidies, but Republicans still canât decide whether they want to put forward their own alternative or ...
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Tracy Beth Hoeg now doubling down on the Prasad email, says FDA is revising their safety surveillance process for vaccines and it may result in more frequent label updates. When Malone asks she seems to suggest they would issue guidance eventually on new vaccine requirements.
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The FDA announced that it has deployed a version of artificial intelligence called âagentic AIâ for âall agency employeesâ to assist with complex tasks, including safety reviews, inspections, and compliance.
civileats.com
FDA Expands Use of Advanced AI for Safety Reviews and Inspections
The agency responsible for most food safety regulation says it is deploying âagenticâ AI, which can make decisions and act without constant human intervention.
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A dozen prior leaders of the FDA, appointed by Republicans and Democrats alike, issued a scathing denunciation of new beliefs casting doubt on vaccine safety.
nbcnews.to
A dozen former FDA leaders lambaste claims by current FDA vaccine chief
The former officials say the agency's plan to revamp how vaccines for flu, Covid and other respiratory viruses are handled could put "millions of Americans at high risk from serious infections."
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@aaaaiorg.bsky.social
about 14 hours agoMondelÄz Global LLC Conducts Limited Voluntary Recall of 1 SKU of RITZ Peanut Butter Cracker Sandwiches in New York, New Jersey, Pennsylvania, Georgia, Arkansas, Missouri, Oklahoma and Alabama
www.fda.gov/safety/recal...
www.fda.gov
MondelÄz Global LLC Conducts Limited Voluntary Recall of 1 SKU of RITZ Peanut Butter Cracker Sandwiches in New York, New Jersey, Pennsylvania, Georgia, Arkansas, Missouri, Oklahoma, and Alabama
EAST HANOVER, N.J., Nov. 28, 2025 (GLOBE NEWSWIRE) -- MondelÄz Global LLC announced today a voluntary recall of 70 cases of RITZ Peanut Butter Cracker Sandwiches and sold in the following U.S. states:...
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Ophthopedia Update: Topcon launches Omnia device for automated pretesting: Omnia, a device capable of fully automated objective refraction, keratometry, tonometry and pachymetry, has been cleared by the FDA and is now available from Topcon Healthcare, according to a⌠#ophthalmology #eye #eyenews
dlvr.it
Topcon launches Omnia device for automated pretesting
Omnia, a device capable of fully automated objective refraction, keratometry, tonometry and pachymetry, has been cleared by the FDA and is now available from Topcon Healthcare, according to a press release. Omnia is intended to make pretesting faster and more efficient. It comes as part of Topconâs Healthcare from the Eye initiative, which is centered on bringing AI insights into routine eye care. âIn order for Healthcare from the Eye to reach its full potential, providers need access to high-quality devices that are reliable and easy to use and make capturing, analyzing and sharing data a
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