In a memo to FDA staff on Friday, Dr. Vinay Prasad, director of the agency’s vaccine division, said the review identified at least 10 children who died “after and because of” Covid vaccinations. He suggested the deaths may have been related to myocarditis, an inflammation of the heart muscle, according to The New York Times.
“This is a profound revelation. USFDA admits for the first time that Covid-19 vaccines have killed American children,” the NYT quoted Dr. Prasad, an oncologist who has been a vocal critic of the U.S. COVID vaccine and face masks, as saying. In September, he returned to his position as the FDA’s chief medical and scientific officer.
The memo, obtained by the NYT but not publicly released, did not include details such as the ages of the children, any underlying medical conditions, the method used to determine the link between the vaccine and the deaths or the vaccine manufacturers involved.
Dr. In his message, Prasad outlined updates to vaccine surveillance and approval and said randomized trials should now include all subgroups, including pregnant women. He also criticized the annual flu vaccine selection process as a “disaster of poor quality evidence” and suggested it would also be reviewed.
Secretary of Health Robert F. Kennedy Jr. significantly changed US policy on COVID vaccinations, limiting their availability to people age 65 and older and those with underlying medical conditions.
Kennedy, who previously campaigned against vaccines before becoming the nation’s top health official under President Donald Trump, has also suggested a link between vaccines and autism and tried to overhaul the country’s immunization policy. During Trump’s first term and continuing under Joe Biden, US health authorities strongly promoted COVID vaccines as life-saving.
A vaccination expert at the Children’s Hospital of Philadelphia disagrees with the post
Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and a critic of Robert F. Kennedy Jr.’s vaccine policies, described the report as an example of science “in a press release.” He noted that the memo lacks important context, such as the number or rate of deaths from COVID-19 itself among vaccinated and unvaccinated children.
Dr. Offit explained that children who developed vaccine-related myocarditis were treated at the hospital and generally recovered quickly. “On the other hand, we have seen children admitted to our hospital with myocarditis caused by a virus. It was quite severe and caused admission to the intensive care unit,” he said.
According to The New York Times, the results of the recent FDA review have not yet been published in a peer-reviewed medical journal. The report also noted that the CDC’s vaccine committee is scheduled to meet next week.
Meanwhile, Michael Osterholm, an infectious disease expert at the University of Minnesota and a critic of Kennedy’s oversight of the health agency, said he believed the memo was deliberately released before the meeting. “This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse effects,” he said.
