FDA Official Plans Vaccine Approval Process Overhaul Following Internal Analysis

Internal Claims and Rationale:

In an internal memo, the FDA official claimed, “Healthy young children who faced tremendously low risk of death were coerced… to receive a vaccine that could result in death” via school and work mandates.

He cited “an initial analysis” that examined 96 deaths and linked 10 to the COVID-19 vaccination, though the memo did not provide specific details on the deaths or how the conclusion was reached. The official also claimed that COVID-19 “was never highly lethal for children” and its effects “are comparable” to those of respiratory viruses for which annual vaccines are not required.

He stressed that vaccines, like any medical product, require appropriate use: “The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm.“

New Approval Process Changes:

The official stated that as a result of the FDA analysis, the agency will adopt a new approval process for vaccines that will require more evidence of their safety and value before they can be marketed. Proposed changes include:

• Stricter requirements for authorization of vaccines used for pregnant women.

• Trials for pneumonia vaccines will need to prove the shots reduce disease, rather than just showing that the vaccine produces enough antibodies.

• Revising the annual flu vaccine framework and “re-appraising safety and being honest in vaccine labels.“

These changes could require larger studies that take longer to complete, potentially slowing the approval process significantly. The official also urged staff members who may disagree with these new core principles to submit their resignation letters.

Healthcare Policy Context:

This announcement is consistent with arguments long made by the Secretary of the Department of Health and Human Services (HHS). The HHS Secretary has repeatedly raised doubts about vaccine effectiveness, slashed funding for mRNA vaccine development, removed all members of the vaccine advisory committee at the Centers for Disease Control and Prevention (CDC), and directed the CDC to change its website to include false claims linking autism and vaccines.

The CDC’s Advisory Committee on Immunization Practices (ACIP), handpicked by the HHS Secretary, is scheduled to meet next week to discuss the childhood vaccine schedule, including considering delaying the first in the series of hepatitis B shots for infants. (This shot has been recommended shortly after birth for over 30 years—a strategy that nearly eradicated the potentially fatal disease among children in the US.)

Source: https://edition.cnn.com/2025/11/29/politics/vaccine-approval-process-fda-official