A dozen former Food and Drug Administration commissioners are condemning a move by the agency’s current top vaccine official, Vinay Prasad, to propose radical changes to the way it reviews new immunizations.
The commissioners, whose tenures date back to the administration of former President George H.W. Bush, argued in an article published in the New England Journal of Medicine that Prasad’s planned policies are based on a “reinterpretation of selective evidence” that “breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity.” Those new rules, if enacted, “undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” they wrote.
Prasad’s contemplated framework, outlined in a memo sent to agency staff last week, proposes mandating that all vaccine applications conduct large, randomized and controlled trials for new shots — even when updating older versions of well-studied shots for influenza and COVID-19. That protocol would break from longstanding standards that enable speedy clearance of these updated shots based on their ability to spur an immune response, a critical tool in keeping up with evolving viral threats.
“It will subject vaccines to a substantially higher and more subjective approval bar. The proposed measures will slow the replacement of older products with better ones and will create potentially prohibitive expenses for new market entrants, especially small biotechnology companies,” the commissioners wrote.
The 12 co-authors constitute all of the living people who have ever held the FDA’s top post on a permanent basis, except for current head Martin Makary and Stephen Hahn, an appointee during President Donald Trump’s first term. They also constitute nearly half of the 25 people who have ever held a permanent title as U.S. commissioner of food and drugs.
To justify changes to vaccine review standards, Prasad claimed, without providing specific data, that at least 10 children had died because of the COVID-19 vaccines. He also further criticized former President Joe Biden’s administration for “coercive and unethical” mandates that children get vaccinated. Such mandates were never enacted on a federal level.
The allegations of vaccine-related deaths came from information logged in the federal government’s Vaccine Adverse Events Reporting System, a database of unverified reports that can be used by anybody who suspects a side effect from a vaccine. In their rebuttal in NEJM, the commissioners noted that VAERS is intended only as an early warning system that requires significant follow-up in carefully designed investigations. The case reports on their own suffer from reporting bias and a lack of comparative data in people who didn’t have side effects.
“Yet accepting the review of VAERS reports as proof that ‘no fewer than 10’ deaths were caused by Covid-19 vaccines, Prasad concludes that the vaccines caused net harm in children — and then seeks to justify sweeping changes in regulatory standards for Americans at much higher risk for complications from many other infectious diseases,” they wrote.
The commissioners added that all the cases of death that could have been related to vaccination were previously reported to the agency as well as the Centers for Disease Control and Prevention. FDA staff, after careful review, “drew different conclusions,” they wrote.
