FDA's vaccine memo reckless, dangerous to public health

[Yo_Mama_Been_Loggin]

By Lisa Jarvis / Bloomberg Opinion

An internal memo written by the Food and Drug Administration’s top vaccine regulator offers a concerning glimpse into the future of vaccine regulation in the U.S.; and could have profound implications for both access to and the development of vaccines.

Vinay Prasad’s memo, which was leaked to the news media, makes alarming claims about the covid-19 vaccine; including the assertion, made without any supporting evidence, that it has caused the death of “at least 10 children.” It also suggests that the FDA will make significant changes to the way vaccines are regulated.

The memo comes at a time of great turmoil at the agency, which intensified this week with the news of yet another leader’s potential exit, and amid increasingly aggressive efforts by Health Secretary Robert F. Kennedy Jr. to both undermine confidence in and limit access to vaccines.

Prasad made the extraordinary claim about the safety of covid vaccines in the email to his staff at the FDA’s Center for Biologics Evaluation and Research (CBER). He said an internal investigation found the children died due to myocarditis, a form of heart inflammation. Yet he provided no data or research to support the claim, an irresponsible and dangerous approach to regulatory oversight.

https://www.heraldnet.com/opinion/comment-fdas-vaccine-memo-reckless-dangerous-to-public-health/

[LetMyPeopleVote]

1. 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