Is FDA about to restrict vaccination even further?

Reports have emerged that Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research (CBER), is planning to tighten up the regulations surrounding vaccines after concluding that COVID-19 shots resulted in the deaths of 10 children.

The source of the reports is an internal email to CBER staff in which Prasad said that, in a "profound revelation," the US medicines regulator will "for the first time […] acknowledge that COVID-19 vaccines have killed American children."

The memo – first revealed on X.com by a PBS journalist and subsequently obtained by various news agencies – also said: "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."

Prasad said in the email that the FDA is looking into a new approval process for vaccines that will require more evidence of their safety and efficacy before they can be cleared for marketing, particularly if they are to be used in pregnant women, which has raised fears of a slowdown in the development of new vaccines for the US market.

He also said there would be a re-examination of annual flu shot policies, calling it an "evidence-based catastrophe," and limits on the administration of combination vaccines, in a new signal of an increasingly vaccine-sceptic stance at the agency under Health and Human Services (HHS) Secretary, Robert F Kennedy Jr, a prominent figure in the anti-vaccine movement.

Prasad said that a review had revealed at least 10 children had died "after and because of" a COVID-19 vaccine, citing data reported to the Vaccine Adverse Event Reporting System (VAERS) on 96 deaths between 2021 and 2024, but did not provide any details about the cases or the circumstances behind their deaths.

In an autocratic move that is increasingly familiar among federal agencies under the Trump administration, Prasad also said that anyone who disagreed with the new regulatory direction should resign.

In the summer, the FDA imposed new restrictions on who can access COVID-19 vaccines, saying that new jabs would only be approved for those over 65 or those at high risk due to other conditions. Previously, they were available to everyone over six months of age under emergency authorisations.

A few weeks later, the CDC's Advisory Committee on Immunization Practices (ACIP) stopped short of requiring prescriptions for a COVID jab, but did indicate they should be used only after discussions between a patient and doctor.

The ACIP is scheduled to meet later this week and has vaccine risk monitoring and the childhood and adolescent immunisation schedule on its agenda, along with a full day on hepatitis B vaccines, having previously postponed a vote on banning the dose administered at birth.

Meanwhile, mRNA-based COVID vaccines had stronger warnings added to their labels earlier this year, and Kennedy cancelled $500 million of federal funding for mRNA vaccine projects, to the delight of vaccine sceptics.

Last month, to the consternation of medical and autism advocacy groups, the CDC also changed wording on its website to suggest vaccines may cause autism, despite decades of research refuting such a link.