A dozen former FDA commissioners have come together to pen a scathing op-ed opposing a plan recently unveiled by the agency’s top vaccine official, Vinay Prasad, to drastically change the standards used to approve shots.
Prasad’s email to staff at the FDA’s Center for Biologics Evaluation and Research on Nov. 28 shocked many public health and infectious diseases experts who saw the email as an indication that the administration is taking a tougher stand on vaccine approvals. Prasad stated that the changes were needed due to the deaths of at least 10 children that he claims were caused by the COVID-19 jab.
“The existing regulatory model builds public trust by encouraging open information exchange and rigorous, transparent scientific debate,” the perspective piece in The New England Journal of Medicine reads. The measures outlined in the memo “are the latest in a series of troubling changes at the FDA, including substantial departures of FDA staff, that could diminish both the FDA’s strength and Americans’ health and safety.”
“The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA’s globally respected scientific integrity. If enacted, the framework would impede the ability to update vaccines to keep up with the natural evolution of respiratory viruses or changes in the prevalence of bacterial serotypes; it would also suppress innovation and competition,” the former commissioners warn.
The op-ed also argues that rather than enhance vaccine science, vaccines will now face “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.”
Prasad’s memo also calls for new studies for vaccines that are regularly updated, such as flu and COVID. But doing this, the commissioners say, “would delay the arrival of better-matched vaccines when new outbreaks emerge or when additional groups of patients could benefit.”
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