A new and controversial internal memo from the U.S. Food and Drug Administration has raised serious questions about the safety oversight of COVID-19 vaccines. The memo, written by Dr. Vinay Prasad, the director of the FDA’s vaccine division, claims that a review inside the agency found that at least 10 children in the United States may have died because of the COVID-19 vaccine.
These findings have not been made public by the agency, but The New York Times obtained them, sparking intense debate across the country.
The issue became even more sensitive after Dr. Marty Makary, a well-known physician linked with the FDA, confirmed in an interview that available data “appears to show” that 10 children died due to the COVID-19 shots. He said this data was collected during the Biden administration.
“It appears that 10 children died due to COVID shots, and this is data collected during the Biden administration,” Makary told Fox News. His comments helped push this matter from an internal memo into a national discussion.
According to The New York Times, the FDA memo did not specify the children’s ages, list any medical conditions they may have had, or identify the vaccine manufacturer involved.
The memo also did not explain in detail how the agency concluded that the vaccine caused the deaths. Because the findings were not published in a peer-reviewed medical journal, many scientists and public health experts are questioning the conclusions and asking the government to release the full evidence.
The memo describes that the children’s deaths were linked to myocarditis, which is inflammation of the heart muscle. Myocarditis has been a known but rare side effect of COVID-19 vaccines, especially in teenage boys and young men. However, medical experts say the condition has also appeared in children infected with COVID-19 itself, and in many cases, the infection-related myocarditis has been far more severe.
Dr. Prasad wrote in the memo, “This is a profound revelation. For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.” The strong language in his memo has surprised many in the scientific community, especially because the memo was not publicly announced and lacks the supporting data that experts say is required for a conclusion of this scale.
Health Secretary Robert F. Kennedy Jr., who was appointed under President Donald Trump, has already brought major changes to the country’s vaccination policies. Kennedy, who was long known as an anti-vaccine activist, has restricted COVID-19 vaccine access to only people aged 65 and older or people with serious medical conditions.
He has also brought reforms to the country’s immunization program and questioned long-standing vaccine practices. His critics say these actions are weakening public health, especially at a time when diseases like measles and whooping cough are rising again in the United States.
The FDA memo lands just days before a major meeting of the Centers for Disease Control and Prevention’s vaccine advisory committee. The committee now includes several members who support the “medical freedom” movement and who reject many vaccine mandates.
Also Read: New Study Shows COVID-19 Vaccines Reduce Heart Attacks and Strokes in Millions of Adults
Public health experts believe the timing of the memo was intentional. Michael Osterholm, an infectious-disease expert at the University of Minnesota, told The New York Times, “This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events.”
The FDA’s proposed changes include requiring large randomized studies for vaccines in all age groups, including pregnant women. Dr. Prasad also questioned the long-used method of updating flu vaccines each year, describing the current evidence behind the updates as a “catastrophe of low-quality evidence.”
He suggested that companies must conduct larger studies before promoting vaccines as safe to take together, such as COVID and flu vaccines during the same visit. He also said pneumonia vaccine makers should prove that their vaccines reduce actual illness, not just increase antibody levels.
These proposals could make vaccine development more expensive and slow down approval of new vaccines. Some experts fear that this will harm the nation’s ability to respond quickly during health emergencies. Others say the new supervision could improve safety but must be backed by strong scientific evidence, not by political pressure.
Dr. Paul Offit from the Children’s Hospital of Philadelphia said the memo lacked important context, including the number of children who died from COVID-19 itself. He added that most children who developed myocarditis after vaccination recovered quickly. “On the other hand, we saw children admitted to our hospital with myocarditis from the virus,” he said. “It was quite severe and caused admissions to the intensive care unit.”
Dr. Peter Marks, who led the FDA vaccine division during the pandemic, said he was shocked by the “clearly political tone” of the memo. He added, “I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex.”
The FDA has not released the full memo to the public, and the Department of Health and Human Services did not respond to requests for comment. The story continues to develop as scientists, parents, lawmakers and public health leaders call for more information, more transparency, and more scientifically reviewed evidence.
