The US Food and Drug Administration (FDA) has announced a stricter vaccine approval process following internal claims that Covid-19 vaccines were linked to the deaths of at least 10 children. The move, led by Dr Vinay Prasad, the agency's top vaccine regulator, has drawn sharp criticism from public health experts who describe the new protocol as 'dangerous and irresponsible'.
An internal memo circulated on Friday and obtained by media outlets outlined plans to re-examine annual flu-shot policies, consider limits on simultaneous vaccinations, and require more robust safety and efficacy data from manufacturers. Dr Prasad stated that a recent review determined 10 children had died 'after and because of' receiving a Covid vaccine, with deaths apparently tied to myocarditis. 'This is a profound revelation,' he wrote, adding that staff who disagreed with the new approach should resign.
Critics, including Dr Paul Offit of Children's Hospital of Philadelphia, questioned the lack of evidence. 'If you think you have an extraordinary claim, you should back it up with extraordinary evidence,' Offit told MedPage Today. Dr Peter Marks, Prasad's predecessor, noted the 'clearly political tone' and said the case reports required further investigation. The memo did not include children's ages, health conditions, or details on how causation was determined.
Current and former FDA staff warned the new plan could slow vaccine development, requiring larger studies and potentially discouraging innovation. The proposal to re-evaluate giving multiple vaccines together could also upend long-standing CDC guidance. Dr Kathryn Edwards of Vanderbilt University stressed that determining vaccine-related deaths is 'a very difficult task' requiring autopsy and exclusion of other causes.
