F.D.A. Seeks More Oversight of Vaccine Trials and Approvals

The agency’s top vaccine regulator proposed broad changes, claiming that a new review linked 10 children’s deaths to the Covid vaccine. But public health experts questioned the findings, wanting to examine the data.

The Trump administration is casting more doubt on the safety of vaccines, with an internal memo from the Food and Drug Administration linking the deaths of at least 10 children to the Covid vaccine and proposing new regulatory measures as a result.

The memo was obtained by The New York Times and not publicly released. It did not provide details such as the ages of the children, whether they had any health problems or how the agency determined the vaccine-death link. Nor did it disclose the maker of the vaccines involved.

The findings have not been published in a peer-reviewed medical journal, drawing suspicion from some critics of Health Secretary Robert F. Kennedy Jr., who has repeatedly criticized the Covid shots as deadly despite the scientific consensus that they are safe.

The memo was written by Dr. Vinay Prasad, the director of the F.D.A.’s vaccine division. He sent it to agency staff members on Friday, outlining findings from a review of reports concerning childhood deaths and attributing them to myocarditis, or inflammation of the heart muscle.

The Covid vaccine, like many other immunizations, carries some health risks in certain cases and mainstream scientists have been studying the vaccine’s effects on people for years, especially the incidence of myocarditis in teenage boys and young men.

“This is a profound revelation,” Dr. Prasad wrote in a memo to staff members. “For the first time, the U.S. F.D.A. will acknowledge that Covid-19 vaccines have killed American children.”

Dr. Prasad said he would propose a range of new oversight and review of vaccines, though it was unclear whether the White House had been advised of the memo’s contents. The proposals could be refined by government officials or challenged by lawmakers and drug companies.

A spokesman for the Department of Health and Human Services, which oversees the F.D.A., did not respond to a request for comment.

The memo represents another escalation of broadsides on vaccines by federal authorities under Mr. Kennedy, who has used his position as secretary to repeatedly raise doubts about inoculations and name other skeptics to positions of authority.

Mr. Kennedy’s team has issued new policies that are limiting access to the Covid shots to people 65 and older as well as to younger people with underlying medical conditions. He and F.D.A. officials have also called for more studies of existing vaccines that have been considered safe for decades.

Health officials in the first Trump administration, when the vaccines were developed during the pandemic, and in the Biden years, strongly endorsed the Covid shots as lifesaving measures. Public health experts have pointed to the number of lives saved by the Covid vaccine and to the fact that the virus caused more than a million deaths among Americans. About 2,100 children have died of Covid since the pandemic began, according to the American Academy of Pediatrics.

Dr. Prasad’s memo is landing just before next week’s meeting of the Centers for Disease Control and Prevention’s influential vaccine committee. Mr. Kennedy’s handpicked panel includes supporters of the so-called medical freedom community, who often reject vaccination and oppose mandates. The committee is expected to discuss the children’s immunization schedule and the hepatitis B vaccine for newborns.

Michael Osterholm, a critic of Mr. Kennedy’s health agency oversight and an infectious disease expert at the University of Minnesota, said he believed the memo was intentionally released before the meeting.

“This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events,” he said.

Among the changes Dr. Prasad outlined for oversight and approval were requirements that studies looking at people using a vaccine or a placebo include all subgroups, such as pregnant women. In addition, he described the annual process of updating flu vaccines to match a circulating strain a “catastrophe of low-quality evidence,” and said it would also be re-examined. (The chosen strain is at times a poor match.)

He also said companies would need to do larger studies before promoting vaccines as safe to administer together, such as the flu and Covid vaccines. And vaccine makers would need to conduct large, randomized studies of pneumonia vaccines to prove that they reduce cases of the disease rather than prove that they generate antibodies.

The changes would most likely raise costs for vaccine makers, which submit studies of their products to the F.D.A. for review and approval decisions. Public health experts also warn that high-profile pronouncements suggesting that vaccines are not safe will erode confidence as measles and whooping cough cases are soaring in the United States.

Dr. Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia and a critic of Mr. Kennedy’s vaccine policies, called the memo an example of science “by press release.”

He said it was missing context such as the number of deaths from the virus itself among vaccinated and unvaccinated children.

Dr. Offit said children with vaccine-related myocarditis showed up at the hospital with cases that resolved 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. Prasad’s memo also took aim at the Biden administration, claiming that mandates for school and workplace inoculations “coerced” people to get Covid vaccines that could result in death.

His predecessor, Dr. Peter Marks, who led the F.D.A. division during the pandemic, said he was taken aback by the “clearly political tone of the communication.” He agreed that the case reports of childhood deaths needed to be opened to further scrutiny to determine whether they were caused by the vaccines.

“I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex,” Dr. Marks said after reading the memo.

The vaccine letter followed Dr. Prasad’s recent missive exhorting staff members to refrain from publishing “obviously erroneous work” instead of studies that further the agency’s mission.

Dr. Prasad, whose leadership style has rankled some people inside and outside the agency, complained in the latest memo of staff members who disagreed with the vaccine division’s direction and new policies, saying they were leaking information. He then outlined how employees could submit their resignations.

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