FDA Implements Stricter Vaccine Approval Process
The Food and Drug Administration's leading vaccine regulator, Dr Vinay Prasad, has announced a significant tightening of federal vaccine approval protocols. This decision follows claims from his team that Covid vaccines were linked to the deaths of at least 10 children, marking a dramatic shift in the agency's approach to immunisation programmes.
Internal Memo Reveals Drastic Policy Changes
According to an internal agency email circulated on Friday and obtained by several media outlets, Dr Prasad informed FDA staff that the agency would fundamentally rethink its vaccination strategy. The memo outlined plans to re-examine annual flu-shot policies, consider limits on simultaneous vaccinations, and require more robust safety data from pharmaceutical manufacturers before granting approvals.
Dr Prasad's communication contained a particularly startling revelation: a recent review allegedly determined that at least 10 children had died "after and because of" receiving a Covid vaccine. He noted these deaths appeared connected to myocarditis, or inflammation of the heart muscle, calling this acknowledgment "a profound revelation" for the US FDA.
Expert Criticism and Potential Consequences
The new framework has drawn sharp criticism from medical experts. Dr Paul Offit of Children's Hospital of Philadelphia described the approach as "dangerous and irresponsible", arguing that extraordinary claims require extraordinary evidence that should undergo peer review.
Current and former FDA staff, along with outside public health specialists, warn that the new requirements could dramatically slow the vaccine pipeline. Requiring larger studies before approvals might delay product launches, make companies more cautious about vaccine development, and potentially discourage innovation in vaccine research.
Dr Kathryn Edwards, a vaccine expert and professor emeritus at Vanderbilt University, emphasised that determining vaccine-related deaths requires careful assessment, stating: "Saying definitively that a vaccine caused a death requires careful assessment, best done with an autopsy examination, and ruling out other causes of death."
The policy changes reflect themes long advanced by US Health Secretary Robert F Kennedy Jr and members of the anti-vaccine movement, who have consistently pressed for additional proof of vaccine safety and effectiveness.
