▼ Summary
– Vinay Prasad, the FDA’s top vaccine regulator, issued a memo making unsubstantiated claims about COVID-19 vaccine deaths in children and announcing sweeping, unilateral changes to vaccine approval processes.
– A dozen former FDA commissioners published a rebuke, calling the memo a “threat” to the agency’s work and a danger to public health.
– Prasad’s planned changes would abandon the current framework for updating vaccines, which uses immunobridging studies, in favor of requiring lengthy and expensive randomized trials.
– Prasad’s memo stated that FDA staff who disagree with the plans should resign and that airing criticisms is considered “unethical” and “illegal.”
– The former commissioners stated the memo is part of a series of troubling changes and that its arguments against the current scientific approach are incoherent and misrepresent the regulatory record.
A group of twelve former commissioners of the Food and Drug Administration has issued a powerful joint condemnation of a recent internal memo from the agency’s top vaccine official. The unprecedented rebuke, published in a leading medical journal, centers on controversial new policy directions that the ex-leaders argue could severely undermine public health and vaccine development. This collective response highlights a significant internal conflict over the future of vaccine regulation in the United States.
The controversy stems from a memo distributed by Dr. Vinay Prasad, the FDA’s chief medical and scientific officer. In the communication, which was subsequently leaked, Prasad made unsubstantiated claims regarding pediatric COVID-19 vaccine fatalities. More consequentially, he announced immediate, sweeping changes to the regulatory framework for authorizing updated vaccines, including those for influenza and coronavirus.
Prasad’s directive calls for abandoning the FDA’s established practice of using immunobridging studies. This scientifically accepted method relies on measuring immune responses to determine if an updated vaccine is likely to be effective. Prasad dismissed this approach as inadequate, mandating instead that manufacturers conduct large, lengthy, and costly randomized controlled trials for every vaccine update. Such a requirement could delay the availability of critical seasonal vaccines by months or even years.
The internal memo also contained a stark warning to agency staff. Prasad stated that employees who disagreed with the new direction could submit their resignation letters. He further characterized the airing of concerns or criticisms about the plans as potentially “unethical” and “illegal,” a stance that has raised alarms about scientific discourse and transparency within the agency.
In their published response, the former commissioners, whose combined leadership spans over 35 years, expressed being “deeply concerned.” They framed Prasad’s actions as a direct “threat” to the FDA’s mission and a danger to Americans’ health. The group labeled the memo the “latest in a series of troubling changes” at the agency and criticized the proposed policy shifts as incoherent.
Crucially, the former leaders argued that Prasad’s case against immunobridging “misrepresent[s] both the science and the regulatory record.” They emphasized that this method is particularly robust for vaccines targeting well-understood pathogens through established mechanisms, a category that includes annual flu shots. Forcing randomized trials for every minor strain update, they contend, is an unnecessary barrier that would slow vital public health interventions without providing meaningful additional safety data.
This extraordinary public disagreement among past and present FDA leadership signals a profound debate over the balance between rigorous oversight and timely medical innovation. The former commissioners’ intervention underscores their view that the proposed changes risk eroding public trust and impeding the agency’s ability to respond swiftly to evolving health threats.
(Source: Ars Technica)
