Health and Me

Ishita Roy

Leaked FDA Memo Sparks Fierce Debate Over Rare Vaccine-Linked Child Deaths

Leaked email that claims death of children by COVID vaccine

After the Thanksgiving, on Friday, the Food and Drug Administration (FDA)'s top vaccine regulator, Vinay Prasad made a clam that shocked the public-health established. "For the first time, the US FDA will acknowledge that <span>COVID-19</span> vaccines have killed American children," he wrote in a leaked email to his staff, as reported by The Atlantic and The Washington Post.

The agency has identified that at least 10 children died after getting COVID shots. 

The email has been perceived by physicians as a "threat". A response from 12 former FDA commissioners, published in The New England Journal of Medicine on Wednesday, called Prasad's memo "a threat to evidence-based vaccine policy and public health security". All of the potential vaccine related deaths reported to government were already reviewed by the agency's staff, and had reached "different conclusions", wrote the former commissioners. 

Elsewhere, doctors and scientists have declared that there are no evidence that links COVID-19 vaccines to deaths in children. The commissioners have claimed that in an attempt to deliberately bring evidence, Prasad and his colleagues had engaged in an "evidence-manufacturing mission", a "dumpster dive" for shoddy data, or worse, a campaign of lying. 

Prasad is one of several public health officials who, under Robert F. Kennedy Jr.’s leadership, have been steadily chipping away at public trust in vaccines. So far, he has not provided evidence to back his claims, and his estimate of vaccine-related deaths may be exaggerated. The memo’s intense language and focus on political complaints also cast doubt on his assertions.

However, something that cannot be ignored is that fact that his memo may have provoked people to deny even the possibility of COVID-vaccine-related deaths. The Atlantic notes that "the idea that mRNA-based shots have, tragically, killed a very small number of children is not far-fetched." The article written by Benjamin Mazer, a physician who specializes in pathology and laboratory, notes that the this does not imply a "catastrophic threat to public health" as tens of millions of doses of the same vaccines have saved young people. 

<h2>Understanding the Debate Of Vaccine-Linked Deaths</h2>

Public-health experts agree that COVID vaccines, like all medical treatments, can cause side effects. Myocarditis, a rare heart inflammation seen mostly in adolescent boys and young men after mRNA shots, remains the most discussed risk. Although usually mild and far less severe than virus-induced myocarditis, a few deaths have been documented worldwide, including isolated cases in the U.S., South Korea, and two American teenagers described in a peer-reviewed report.

These findings fuel ongoing debate about whether extremely rare vaccine-related deaths are being overlooked. Some scientists, including Paul Offit and Michael Osterholm, say the evidence does not prove the vaccines caused these deaths, noting that population-level studies show no rise in mortality after vaccination. Others argue that well-investigated autopsy-confirmed cases should be taken seriously rather than dismissed outright.

Experts such as Krutika Kuppalli, as cited by Mazer, emphasize that even if deaths occur, they are so uncommon they do not appear statistically, while the benefits, significantly reduced COVID mortality, are unmistakable. However, individual cases still raise questions on health authorities and the stricter standards of proofs they have applied when vaccines were involved to create a room for skepticism.

The concern is that rare side effects of vaccines could go undiscovered and not that vaccinations are inherently harmful.

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After the Thanksgiving, on Friday, the Food and Drug Administration (FDA)'s top vaccine regulator, Vinay Prasad made a clam that shocked the public-health established. "For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children," he wrote in a leaked email to his staff, as reported by The Atlantic and The Washington Post. The agency has identified that at least 10 children died after getting COVID shots. The email has been perceived by physicians as a "threat". A response from 12 former FDA commissioners, published in The New England Journal of Medicine on Wednesday, called Prasad's memo "a threat to evidence-based vaccine policy and public health security". All of the potential vaccine related deaths reported to government were already reviewed by the agency's staff, and had reached "different conclusions", wrote the former commissioners. Elsewhere, doctors and scientists have declared that there are no evidence that links COVID-19 vaccines to deaths in children. The commissioners have claimed that in an attempt to deliberately bring evidence, Prasad and his colleagues had engaged in an "evidence-manufacturing mission", a "dumpster dive" for shoddy data, or worse, a campaign of lying. Prasad is one of several public health officials who, under Robert F. Kennedy Jr.’s leadership, have been steadily chipping away at public trust in vaccines. So far, he has not provided evidence to back his claims, and his estimate of vaccine-related deaths may be exaggerated. The memo’s intense language and focus on political complaints also cast doubt on his assertions.However, something that cannot be ignored is that fact that his memo may have provoked people to deny even the possibility of COVID-vaccine-related deaths. The Atlantic notes that "the idea that mRNA-based shots have, tragically, killed a very small number of children is not far-fetched." The article written by Benjamin Mazer, a physician who specializes in pathology and laboratory, notes that the this does not imply a "catastrophic threat to public health" as tens of millions of doses of the same vaccines have saved young people. Understanding the Debate Of Vaccine-Linked DeathsPublic-health experts agree that COVID vaccines, like all medical treatments, can cause side effects. Myocarditis, a rare heart inflammation seen mostly in adolescent boys and young men after mRNA shots, remains the most discussed risk. Although usually mild and far less severe than virus-induced myocarditis, a few deaths have been documented worldwide, including isolated cases in the U.S., South Korea, and two American teenagers described in a peer-reviewed report.These findings fuel ongoing debate about whether extremely rare vaccine-related deaths are being overlooked. Some scientists, including Paul Offit and Michael Osterholm, say the evidence does not prove the vaccines caused these deaths, noting that population-level studies show no rise in mortality after vaccination. Others argue that well-investigated autopsy-confirmed cases should be taken seriously rather than dismissed outright.Experts such as Krutika Kuppalli, as cited by Mazer, emphasize that even if deaths occur, they are so uncommon they do not appear statistically, while the benefits, significantly reduced COVID mortality, are unmistakable. However, individual cases still raise questions on health authorities and the stricter standards of proofs they have applied when vaccines were involved to create a room for skepticism.The concern is that rare side effects of vaccines could go undiscovered and not that vaccinations are inherently harmful.