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A Medsky Topics feed composed of posts covering recent news related to the U.S. Food and Drug Administration Powered by @medsky.social

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  • 💙 Liked by 15 users
  • 📅 Updated 7 days ago
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Amesh Adalja
@ameshaa.bsky.social
1 minute ago
In this piece I’m quoted about the necessary level of explanation and detail needed to make an assertion such as the FDA made without such explanation and details. So one is left only to think of it is more anti-vaccine advocacy from RFK’s agencies abcnews.go.com/US/fda-links...
FDA links 10 children's deaths to COVID-19 vaccines. Doctors want proof

abcnews.go.com

FDA links 10 children's deaths to COVID-19 vaccines. Doctors want proof

The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and approval protocol for vaccine trials.

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Dr. Richard Pan
@drpanmd.bsky.social
about 3 hours ago
For a parent, sibling, or other family member or friend of the hundreds of children who died of #COVID or are disabled from #LongCOVID , COVID does not present a “tremendously low risk” to children. COVID was a top 10 cause of death in children at the pandemic’s peak. #PedSky #FDA

The FDA's Vinay Prasad says children face “a tremendously low risk of death.” Actually, 821 kids <19 died of Covid during a 12-month perdiod, according to a 2023 JAMA paper. www.statnews.com/2025/11/29/c...

www.statnews.com

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Timothy Caulfield
@caulfieldtim.bsky.social
about 3 hours ago
When iffy "evidence" used for policy & fearmongering... FDA claims Covid shots killed 10 children and vows new vaccine rules www.nbcnews.com/health/he…. via @nbcnews.com Meme "is misusing information from VAERS, an unverified reporting system..." And "irresponsible" & "dangerous."
FDA claims Covid shots killed 10 children and vows new vaccine rules

www.nbcnews.com

FDA claims Covid shots killed 10 children and vows new vaccine rules

Vaccine experts said the memo was irresponsible and omits key details about how officials arrived at the conclusion.

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Amesh Adalja
@ameshaa.bsky.social
1 day ago
In this video I discuss some of the very serious implications regarding the FDA’s memo purporting to show a link between COVID vaccines and deaths.
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Richard M. Carpiano, PhD, MPH
@rmcarpiano.medsky.social
1 day ago
Recall when pharma did "publication by press release" for COVID vaccines & hit business news channels as stock market opened? This is a variant of that move. Prasad's memo -no public -no details of claims -findings unpublished in a peer-reviewed sci journal -released bf next wk’s CDC’s ACIP mtg 🛟😷
F.D.A. Seeks More Oversight of Vaccine Trials and Approvals

www.nytimes.com

F.D.A. Seeks More Oversight of Vaccine Trials and Approvals

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Eric Michael Garcia
@ericmgarcia.bsky.social
1 day ago
A top FDA regulator called for tighter government vaccine oversight, including stricter guidelines for the annual flu shot and new vaccines, after an internal agency review linked COVID-19 vaccines to the deaths of 10 children. www.axios.com/2025/11/29/f...
Top FDA official threatens to crack down on vaccine approvals

www.axios.com

Top FDA official threatens to crack down on vaccine approvals

The internal memo comes after an internal agency review linked COVID-19 vaccines to the deaths of 10 children.

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Richard M. Carpiano, PhD, MPH
@rmcarpiano.medsky.social
1 day ago
These COVID vax death claims & policy by Vinay Prasad are unsurprising given his long problematic contrarian crusade. If only his BS cld've waited until after the holiday. If past VAERS data claims are indicators, there will be much to scrutinize abt this--& now he's making policy off it. 🛟 😷 medsky
2 screenshots of X tweet thread by journalist Ali Rogin on Nov. 25, 2025. Text below is copy and paste verbatim from her 4 tweets...

Tweet 1: NEW: In an email sent to staff this afternoon, CBER chief Vinay Prasad says the @US_FDA for the first time "will acknowledge that COVID-19 vaccines have killed American children," which he calls a "profound revelation."

Tweet 2: He says that assessment is based on a "detailed analysis of deaths voluntarily reported to the VAERS system," and that following an initial analysis of 96 deaths between '21 and '24, they've identified "no fewer than 10" that are related to the shot

Tweet 3: He says that based on this analysis, "we will take swift action regarding this new safety concern" and "will demand pre-market randomized trials assessing clinical endpoints for most new products."

Tweet 4: Prasad also says the FDA will "revise the annual flu vaccine framework" which he calls "an evidence-based catastrophe," and he invites people who disagree with this new direction to resign. "For those who choose to remain... I look forward to working with you," he concludes.
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Dr. Lucky Tran
@luckytran.com
1 day ago
In a new leaked memo, the FDA outlined plans to make it much harder to get new vaccines approved, claiming, without sharing evidence, that the COVID vaccines have killed at least 10 children. This is so reckless. The science shows us that COVID vaccines have saved millions of lives.
Subject: Deaths in children due to COVID-19 vaccines and CBER’s path forward

Dear Team CBER,

I am writing to report that OBPV career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination. These deaths arerelated to vaccination (likely/probable/possible attribution made by staff). That number is certainly an underestimate due to underreporting, and inherent bias in attribution. 

….

For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines.

….

Putting these facts together, it is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection.

Vinay Prasad MD MPH
CBER Director, CMSO US FDA
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Jonathan Howard
@joho.bsky.social
1 day ago
We are supposed to believe that FDA paused and removed the J&J vaccine immediately after 6 cases of clotting, but they hid 10 kids dying from the mRNA vaccines until Prasad and Hoeg, who were always antivaxx, revealed the truth. Checks out.
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Jonathan Howard
@joho.bsky.social
1 day ago
Here’s a video of Makary in 2023 saying Kennedy’s “stories” of kids who died after the Covid vaccine were “100% true.” Remember, these guys had their minds made up. It was never about data and evidence. More... youtu.be/CDBM8UvN-xk
Marty Makary praises and lies about RFK Jr. Truth is in the comments

youtu.be

Marty Makary praises and lies about RFK Jr. Truth is in the comments

YouTube video by Jonathan Howard

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Jonathan Howard
@joho.bsky.social
1 day ago
And i guess this is why Hoeg and Prasad didn’t publish their 10 cases in a medical journal- no one at the FDA would out their name on it.

Here’s how FDA staffers, the ones we can trust, reacted to Hoeg and Prasad data 2 weeks ago. Per @lizzylawrence.bsky.social

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NPR
@npr.org
1 day ago
Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID shots for kids. But public health experts question the agency's analysis. n.pr/44yMDxJ
FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids' deaths

n.pr

FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids' deaths

Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID shots for kids. But public health experts question the agency's analysis.

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Betty C. Jung
@bettycjung.bsky.social
1 day ago
NBC News Saturday, November 29, 2025 FDA claims Covid shots killed 10 children in an internal memo experts say lacks evidence The director of the FDA's vaccine division told staff in a memo that an internal review found at least 10 children died "after and because of receiving" the Covid vaccine.
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NBC News
@nbcnews.com
1 day ago
The FDA claims in an internal memo that Covid shots killed at least 10 children, a conclusion experts say was made without substantial or peer-reviewed evidence.
FDA claims Covid shots killed 10 children and vows new vaccine rules

nbcnews.to

FDA claims Covid shots killed 10 children and vows new vaccine rules

Vaccine experts said the memo was irresponsible and omits key details about how officials arrived at the conclusion.

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