FDA attributes 10 children’s deaths to COVID vaccines
Director Dr. Vinay Prasad suggested in the note that the deaths were related to myocarditis or inflammation of the heart muscle.
The memo, which was obtained by The New York Times and was not made public, did not include details such as the ages of the children, whether they had other health problems or how the institution determined the vaccine-death link. He also did not disclose the manufacturer of the relevant vaccines.
“This is a profound statement,” Prasad wrote in a memo to staff. “For the first time, the US FDA will admit that Covid-19 vaccines are killing American children.”
Prasad declined to be interviewed for this article.
His letter was addressed to Robert F. Kennedy Jr., the nation’s health secretary and a longtime vaccine critic who has frequently described COVID vaccines as unsafe. It represents another sharp U-turn by federal officials under his administration. By contrast, health officials in the early Trump administration, where vaccines were developed during the pandemic and during the Biden years, have strongly supported COVID vaccines as life-saving measures. Kennedy’s team has issued new policies limiting access to vaccines to people 65 and older, as well as younger people with underlying conditions. medical conditions.
Public health experts have vociferously challenged claims by Kennedy and these Trump administration health officials that Covid vaccines are dangerous. Previous federal health officials have acknowledged serious but rare side effects from the vaccines, including cases of myocarditis among teenage boys and men.
But public health experts also pointed to the number of lives the vaccines have saved and that the virus has caused more than 1 million deaths among Americans. According to the American Academy of Pediatrics, nearly 2,100 children have died from Covid-19 since the beginning of the pandemic.
The findings of the new FDA review have not been published in a peer-reviewed medical journal.
Dr., a vaccine expert at the Children’s Hospital of Philadelphia and a critic of Kennedy’s vaccine policies. Paul Offit described the memo as an example of science “by press release.”
He said the memo lacked context, such as the number or rate of deaths from the virus among vaccinated and unvaccinated children.
Offit said children with vaccine-related myocarditis were admitted to the hospital and the cases were resolved quickly.
“On the other hand, we also saw children admitted to our hospital due to myocarditis caused by the virus,” he said. “It was quite severe and resulted in admission to the intensive care unit.”
Some of Kennedy’s anti-vaccine allies have been pressing the government for years to take a deeper look at the agency’s database of unverified reports of harmful effects of COVID vaccines. The memo said the analysis of deaths reported to the agency was conducted by Dr. It was stated that it was conducted by Tracy Beth Hoeg and reviewed by a team at the institution.
In his note, Prasad also announced changes to vaccine surveillance and approval and said randomized studies will be needed to cover all subgroups, such as pregnant women. He also described the annual framework for flu vaccine selection as a “disaster of low-quality evidence” and said it would also be re-examined.
Prasad’s memo will be released just before the Centers for Disease Control and Prevention’s influential vaccine committee meets next week. Kennedy’s hand-picked panel includes supporters of the so-called medical freedom community, who generally avoid vaccines and defy mandates.
Michael Osterholm, an infectious diseases expert at the University of Minnesota who has criticized Kennedy’s oversight of the health agency, said he believed the memo was released intentionally before the meeting.
“This is an irresponsible way to deal with such a critical public health issue as vaccination and adverse events,” he said.
The CDC committee is expected to discuss the broader childhood vaccination program.
There are also plans to review the hepatitis B vaccine, which Kennedy and others consider unnecessary for newborns. Proponents of the vaccine say it is the best way to protect against mother-to-child transmission.
The CDC panel also created a subgroup specifically to examine COVID vaccines, led by Massachusetts Institute of Technology management expert Retsef Levi, who called them a failed product that caused “serious harm, including death.”
Dr., who runs the FDA division that regulates vaccines during the pandemic. Peter Marks said he was surprised by the “clearly political tone of the communication”.
He acknowledged that case reports should be opened to further scrutiny.
After reading the memo, Marks said, “I wouldn’t be surprised if the attributions turned out to be controversial, as these cases are often quite complex.”
Prasad, whose leadership style irritated some people inside and outside the agency, filed a complaint saying staff members had leaked information in his memo opposing the agency’s direction and new policies. He then outlined how employees could submit their resignations. The statement follows a recent letter to staff urging them to refrain from publishing “clearly flawed studies” in lieu of studies that would advance the agency’s mission.
This article was first published in The New York Times.
