A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines.
In an internal memo to staff, Vinay Prasad, MD, the FDA’s chief medical and scientific officer and director of its vaccine division, shared findings from a review of reports he said demonstrated a link between COVID vaccination and childhood deaths. The news was first reported by The New York Times, which obtained the memo.
“This is a profound revelation,” Dr. Prasad wrote in the memo. “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”
The memo did not include details on how the agency came to that conclusion or data used in the review, such as the children’s ages or whether they had existing health conditions. The findings were not published in a peer-reviewed medical journal, according to the Times.
HHS, which oversees the FDA, did not respond to Becker’s request for comment in time for publication.
Five notes:
1. In the memo, Dr. Prasad attributed the deaths to myocarditis, or inflammation of the heart muscle. While studies have found a link between myocarditis and the vaccines, experts have said the risk of the condition is far higher after a bout with the infection itself. The mortality rate among individuals with virus-associated myocarditis is significantly higher than developing the condition from the vaccine, research shows.
In June, the FDA finalized updates to the labeling of Pfizer and Moderna’s COVID vaccines, reflecting new data on the risk of myocarditis or pericarditis — inflammation of the membrane surrounding the heart. The updated label stated data on the risk association, noting the rate of the conditions was around 8 cases per million doses among individuals 6 months to 65 years old.
2. Public health experts have questioned findings cited in the memo, saying it is missing key data points, such as the number of deaths from the coronavirus itself among vaccinated and unvaccinated children. Around 2,100 children have died from COVID since the start of the pandemic, according to the American Academy of Pediatrics.
In a statement, the Infectious Diseases Society of America said the agency’s conclusions lack evidence and transparency.
“Any death is tragic; however, the Food and Drug Administration’s vague declaration about the COVID-19 vaccine and pediatric deaths undermines confidence in the safety of the vaccine and raises questions about FDA’s own approval process. The statement lacks evidence and harms the public,” the group said.
“Vaccines save lives, period. FDA’s reckless statements counter decades of evidence demonstrating the safety and importance of vaccines, including the COVID vaccine, which has been studied for the past five years.”
3. In the memo, Dr. Prasad outlined a range of changes to the agency’s approval process for vaccines that would require vaccine manufacturers to conduct larger studies that take longer to complete. Among the changes listed include more stringent requirements and evidence of safety and efficacy before approval. For example, studies comparing individuals in a vaccine or placebo group must include all subgroups, including pregnant women.
Dr. Prasad also said makers of pneumonia vaccines would need to conduct randomized trials to show they reduce disease incidence rather than producing antibodies to fight off the illness. Additionally, he said the agency will “revise the annual flu vaccine framework,” describing the current process of updating annual flu shots to match circulating strains as a “catastrophe of low-quality evidence.”
4. Any debates about the changes, Dr. Prasad said, should occur within the agency. “Some staff may not agree with these core principles and operating principles,” he wrote, inviting those staff members to submit resignation letters.
5. The memo comes ahead of a planned meeting of the CDC’s Advisory Committee on Immunization Practices. The committee — which HHS Secretary Robert F. Kennedy Jr. overhauled in June, appointing several members with a history of anti-vaccine rhetoric — will meet Dec. 4-5 to discuss the childhood immunization schedule and timing of the hepatitis B vaccine.
