FDA Official Announces Plans to Revamp Vaccine Approval Process, Citing Concerns Over Child Deaths Following COVID-19 Shots
WASHINGTON – A senior official at the Food and Drug Governance (FDA) announced Friday plans to overhaul the agencyS vaccine approval process, asserting a link between COVID-19 vaccinations and reported child deaths. The move, signaling a dramatic shift in federal vaccine policy, has ignited controversy among medical experts and public health officials.
The proposed changes come as scrutiny intensifies over the safety and efficacy of COVID-19 vaccines,especially in younger populations. while health authorities maintain the vaccines are safe and effective, the FDA official’s announcement acknowledges growing concerns and calls for a more rigorous evaluation of potential risks. This progress impacts millions of American families and could reshape the future of vaccination programs nationwide.
The initiative aligns with arguments long made by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., who has repeatedly questioned vaccine effectiveness and previously founded the anti-vaccine group Children’s Health Defense.
As HHS secretary, Kennedy has 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 that link autism and vaccines.
The CDC’s Advisory Committee on Immunization Practices, handpicked by kennedy, is scheduled to meet next week to discuss the childhood vaccine schedule and the timing of the hepatitis B vaccine, according to a draft agenda. For over three decades, the first dose of the hepatitis B vaccine has been recommended for infants shortly after birth-a strategy that nearly eliminated the potentially fatal disease among children in the US. Despite no new evidence regarding the vaccine’s safety or effectiveness,the new advisory panel is considering delaying the first shots by months or years.
The FDA official’s announcement detailed a multi-pronged approach to vaccine approval, including longer clinical trial periods, increased post-market surveillance, and a greater emphasis on individual risk assessments. The official specifically cited reports submitted to the Vaccine Adverse Event Reporting System (VAERS) detailing deaths among children following COVID-19 vaccination as a key driver of the proposed changes.
“We have a duty to thoroughly investigate these reports and ensure that our vaccine policies prioritize the safety of all Americans, especially our children,” the official stated in Friday’s memo. “The current process has not adequately addressed these concerns, and a essential change is necessary.”
The move is expected to face significant opposition from the medical community, which has largely championed vaccination as a cornerstone of public health. Critics argue that the proposed changes are based on misinformation and could undermine efforts to control infectious diseases.
CNN’s Jamie Gumbrecht contributed to this report.
