FDA claims on COVID-19 vaccine safety are unsupported by reliable data - and could severely hinder vaccine access

[marmar]

FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access
Published: December 3, 2025 4:16pm EST

Frank Han
Assistant Professor of Pediatric Cardiology, University of Illinois Chicago


(The Conversation) The Food and Drug Administration is seeking to drastically change procedures for testing vaccine safety and approving vaccines, based on unproven claims that mRNA-based COVID-19 vaccines caused the death of at least 10 children.

....(snip)....

Citing an internal, unpublished review, the memo, written by the agency’s top vaccine regulator, Vinay Prasad, attributes the children’s deaths to myocarditis, an inflammation of the heart muscle. And it says the deaths were reported to the Vaccine Adverse Event Reporting System, or VAERS, but provides no evidence that the vaccines caused the deaths.

The death of children due to an unsafe vaccine is a serious allegation. I am a pediatric cardiologist who has studied the link between COVID-19 vaccines and heart-related side effects such as myocarditis in children. To my knowledge, studies to date have shown such side effects are rare, and severe outcomes even more so. However, I am open to new evidence that could change my mind.

But without sufficient justification and solid evidence, restricting access to an approved vaccine and changing well-established procedures for testing vaccines would carry serious consequences. These moves would limit access for patients, create roadblocks for companies and worsen distrust in vaccines and public health. ....................(more)

https://theconversation.com/fda-claims-on-covid-19-vaccine-safety-are-unsupported-by-reliable-data-and-could-severely-hinder-vaccine-access-271028

[Lovie777]

1. Stop lying................

[NewHendoLib]

2. where the ever loving fuck is this misadministration trying to drag the world to?

Who actually benefits from plastering the world with bullshit like this?

[Ferrets are Cool]

3. FUCK this regime.

[Hey Joe]

4. Waging a war of lies, cruelty, hatred and

rank incompetence on the American people and government.
If we ever recover from this onslaught of greed and corruption, it will take years and many deaths to do it.
Come on midterm elections!

[Baitball Blogger]

5. Ten? Is that their benchmark?

So, how many babies have died from the measles because they were unvaccinated?

[MustLoveBeagles]

6. Thank you

[LetMyPeopleVote]

7. MaddowBlog-GOP's Bill Cassidy criticizes Kennedy's vaccine panel, but the senator isn't prepared to act

In a brutal week for public health, the chairman on the Senate health committee could act. So why doesn’t he?

As Trump hires another ballroom architect for his White House vanity project, a question hangs overhead: Will he ever devote this much attention to governing and policymaking?

I think we know the answer. www.ms.now/rachel-maddo...

— Steve Benen (@stevebenen.com) 2025-12-05T14:04:30.667Z

https://www.ms.now/rachel-maddow-show/maddowblog/gops-bill-cassidy-criticizes-kennedys-vaccine-panel-but-the-senator-isnt-prepared-to-act

On Friday morning, things continued their slide from bad to worse. MS NOW reported:

Without data to support their decision and defying warnings from doctors, medical associations and public health groups, a federal advisory panel stocked with loyalists to Health and Human Services Secretary Robert F. Kennedy Jr. has voted to stop recommending a life-saving vaccine to infants at birth.

The Centers for Disease Control and Prevention will stop recommending the hepatitis B birth dose for infants — specifically those born to mothers who test negative for the virus — until they’re at least 2 months old, following a vote on Friday morning by the Advisory Committee on Immunization Practices (ACIP). Eight panel members voted to stop the recommendation, with three dissenting.

....Republican Sen. Bill Cassidy of Louisiana, a former physician who chairs the Senate Health, Education, Labor and Pensions Committee, which has oversight of the Department of Health and Human Services, has raised related concerns. The day before the vote, the senator said online, “The ACIP is totally discredited. They are not protecting children.”

A day later, Cassidy published a follow-up online statement:

Link to tweet

.....The latter half of the quote, however, wasn’t quite right. Cassidy, in a position of real power and influence on Capitol Hill, has plenty of other options. He could concede publicly that confirming Kennedy was a tragic mistake; he could call for Kennedy’s resignation; he could even schedule hearings and haul officials from HHS, CDC and the FDA to Capitol Hill to demand answers and changes.

Cassidy isn’t doing any of these things. He’s instead publishing a couple of tweets, criticizing radical and dangerous public health moves in the mildest of ways.

I can’t ready the senator’s mind. Maybe he’s worried about the GOP primary challenge he’s facing in Louisiana next year? Maybe he’s letting partisan considerations hold him back? Maybe he’s under pressure from Republican leaders not to do anything more consequential?

Whatever his motivation, Cassidy can’t escape responsibility for the damage Kennedy and his cohorts are doing to the nation’s public health, and while he could take meaningful actions in response, the senator is choosing not to, seemingly indifferent to the consequences of his inaction.

[Skittles]

9. can someone tell me WTF the goal is here

Last edited Sat Dec 6, 2025, 06:02 AM - Edit history (1)

I understand RFK Jr is a fucking nutcase who has hired even more fucking nutcases but WHAT is the incentive for THE ENTIRE GOP to go along with something that could easily negatively affect THEM AND THEIR FAMILIES?????

[LetMyPeopleVote]

10. MaddowBlog-Why Americans should care about Aaron Siri's work with RFK Jr.

Siri famously petitioned the government to revoke its approval of the polio vaccine. His ongoing work with Secretary Robert F. Kennedy Jr. matters.

Why Americans should care about Aaron Siri’s work with RFK Jr. Siri famously petitioned the government to revoke its approval of the polio vaccine. His ongoing work with Secretary Robert F. Kennedy Jr. matters. www.ms.now/rachel-maddo...

— (@jwwcan.bsky.social) 2025-12-08T16:15:51.109Z

https://www.ms.now/rachel-maddow-show/maddowblog/aaron-siri-robert-f-kennedy-vaccines

The Times’ report added, “Mr. Siri has also filed a petition seeking to pause the distribution of 13 other vaccines; challenged, and in some cases quashed, Covid vaccine mandates around the country; sued federal agencies for the disclosure of records related to vaccine approvals; and subjected prominent vaccine scientists to grueling videotaped depositions.”.....

Kennedy ignored the advice. Indeed, after the longtime anti-vaccine conspiracy theorist took the reins at the Department of Health and Human Services, Siri’s name popped up quite a bit. In September, for example, after Susan Monarez was fired as the director of the Centers for Disease Control and Prevention, she testified before a Senate committee and spoke about RFK Jr. urging her to meet with Siri. A month later, the Times reported that Siri “has played a role in vetting candidates for departmental jobs.”

Last week, the problem went from bad to worse. NBC News reported:

An anti-vaccine lawyer who has regularly sued federal and state health agencies spoke Friday at a meeting of the Centers for Disease Control and Prevention’s vaccine advisory panel — an unheard-of departure for the committee, which for decades was a trusted source for vaccine recommendations.

After Siri’s lengthy anti-vaccine presentation before the CDC’s once-respected Advisory Committee on Immunization Practices (better known as ACIP), MS NOW’s Brandy Zadrozny wrote online, “This panel is anti-vaccine theater. It’s a cruel joke.”....

Republican Sen. Bill Cassidy of Louisiana, a former medical doctor who chairs the Senate committee that oversees HHS, wrote online the day before Friday’s meeting, “Aaron Siri is a trial attorney who makes his living suing vaccine manufacturers. He is presenting as if an expert on childhood vaccines. The ACIP is totally discredited. They are not protecting children.”

Nevertheless, despite the circumstances, Siri’s side is winning: On Friday, ACIP, stocked with Kennedy loyalists, voted to stop recommending a life-saving hepatitis B vaccine to infants.

Cassidy described the regressive and radical step as a “mistake” — though as is too often the case, the powerful senator declined to respond with anything meaningful.

Rachel discussed this asshole last night