The Food and Drug Administration is examining rare cases involving the deaths of young people after they received Covid vaccines and is also seeking undisclosed details about the safety of the shots for pregnant women.
The agency’s review follows years of exhaustive work by government officials and academic researchers worldwide who have validated the safety of the vaccines.
Many public health experts view the new focus as a political exercise in service of the health secretary, Robert F. Kennedy Jr., who has repeatedly suggested that the inoculations are deadly. And some of Mr. Kennedy’s anti-vaccine allies have been pressuring the government to delve deeper into the databases that include reports of harmful effects from the Covid shots.
The F.D.A.’s efforts could ratchet up tensions over the vaccine and tarnish the legacy of President Trump’s championing of vaccines during the pandemic. He has received widespread, bipartisan credit for Operation Warp Speed, the government-financed program that rapidly delivered millions of lifesaving Covid vaccines using mRNA technology.
The agency’s reviews are gearing up in the week before an influential Centers for Disease Control and Prevention committee is scheduled to discuss the Covid shots and issue recommendations for the fall that could limit insurance coverage and availability in some states.
At the meeting, Dr. Tracy Beth Hoeg, an F.D.A. official who previously advised Dr. Joseph Ladapo, the Florida surgeon general and vaccine critic, is expected to present details about a small number of deaths in children that were attributed to the shots.
Dr. Marty Makary, the commissioner of the F.D.A., said on CNN on Sept. 10 that “nobody really has good data” that could answer some specific questions, including whether there had been cases last year in which pregnant women died from Covid. (Hundreds of pregnant women died of Covid during the early years of the pandemic.)
“We are getting the data that was never made available before, including adverse event data — that is, young people who have died from the Covid vaccine,” Dr. Makary said. “And we’re going to make that available to the medical community in full transparency, because this is the question that Americans are asking.”
There is no official figure from federal health agencies on U.S. deaths linked to the Covid shots, though some post-vaccination deaths have been reported by experts.
People with knowledge of the reviews said the agency was moving ahead on two tracks: a review of reports submitted to the agency of harm or death in children after they received Covid vaccines and of more data on vaccine use among pregnant women, focused on reports of birth defects.
Volumes of data have supported the use of Covid vaccines in pregnant women. Their shots also protect newborns whose risk of hospitalization from Covid during the first six months of life is similar to that of adults ages 65 to 74.
Dr. Hoeg’s review is focused on case reports involving children who died soon after receiving Covid shots, including at least one death linked to myocarditis, or inflammation of the heart muscle.
By contrast, Covid infections were implicated in about 1,800 deaths among children younger than 18, according to C.D.C. data.
The agency reviews appear to be in response to mounting claims — especially from Mr. Kennedy — that data has been hidden from the public.
Drug makers are required to send all reports of harm related to drugs or vaccines to the F.D.A., even if they may be unrelated. Doctors and consumers can also submit reports, which often number in the thousands related to medications or devices, to the agency. Some reports in the vast database have not been investigated or verified by the agency or other authorities.
A review by The New York Times of reports filed through 2023 with the Vaccine Adverse Event Reporting System shows that about 80 involved Covid vaccines and deaths in people younger than 18.
The reports include some that were clearly unrelated to the vaccine, such as suicides with a gun. Others were vague, including a description of a death involving a 13-year-old boy who had “flu-like symptoms for two days then was found deceased,” that was filed in a report by someone who learned of it on a news account.
Several reports of fatalities mentioned myocarditis, a known complication of many respiratory infections, including Covid and the flu. Boys and young men ages 12 to 24 who receive the Covid shots were known to be at increased risk of myocarditis.
The C.D.C. has said there were no confirmed deaths related to myocarditis, but there have been several accounts of deaths reported post-vaccination.
Some of the reports submitted to the F.D.A. were complicated. One describes a 17-year-old girl who had Covid and recovered in August 2021. In September of that year, she received two doses of the Pfizer vaccine.
In late October, she went to an emergency room with chest discomfort and was found to have elevated levels of proteins called troponin, which can indicate heart problems. The report said she suffered a heart attack and died at the hospital. Her cause of death, the F.D.A. report says, was “possible acute myocarditis.”
Earlier this month, Dr. Makary said on CNN that his agency’s review of such cases had shown that “there have been children that have died from the Covid vaccine.”
“We are doing an intense investigation,” he said, describing an effort to talk to families, review autopsy reports and have doctors look at medical records. “We think the public deserves to have that information. It was not released in the last administration, and it should have been.”
Dr. Peter Marks, the former top F.D.A. vaccine regulator who was fired early in Mr. Kennedy’s term, said the agency had carefully examined the case and autopsy reports.
“To the best we could see, these vaccines were not associated with the deaths of children,” Dr. Marks said. “Is it possible that a death could have occurred that was related to the vaccines? Yes, I guess, possible. But in terms of the millions of doses given of these mRNA vaccines, they really had — aside from the known side effect of myocarditis, pericarditis — they had a very good safety profile.”
Another F.D.A. review is being led by Dr. Vinay Prasad, the top vaccine official at the agency, who was an academic oncologist and epidemiologist. He often criticized pandemic-era public health measures and widespread vaccination of healthy children.
He is seeking more patient case details from Pfizer and Moderna related to birth defects in children born to women who were vaccinated, according to people with knowledge of the matter.
In a study released by Pfizer earlier this week, the company said the incidence of birth defects associated with its vaccine was not significantly different from that for the general population.
Pfizer noted that a large European study had found no increase in birth defects among women who were vaccinated or infected with Covid.
Covid infections have been associated with a spike in maternal mortality and an increase in stillbirths. Pfizer cited an analysis of 177 studies looking at more than 630,000 pregnant women that found significant reductions in stillbirth among women who had received mRNA vaccines.
Still, the F.D.A. has sought more detail on the birth defect cases in the Pfizer study.
The agency’s review of data on pregnant women was previously reported by The Wall Street Journal.
The effort to zoom in on individual cases of harm is reminiscent of Mr. Kennedy’s work as an anti-vaccine activist during the pandemic. He faced a ban on social media for suggesting with no evidence that people had died after getting Covid shots.
In recent days, Mr. Kennedy has called for an overhaul of the reporting system on vaccine events, saying that officials need to review each case to learn as much as they can.
“We are recasting the entire program so that vaccine injuries will be reported, they will be studied, that individuals who suffer them will not be denied or marginalized or vilified or gas-lighted,” Mr. Kennedy said at an event earlier this week.
During the meeting next week, members of the C.D.C.’s Advisory Committee on Immunization Practices are expected to issue recommendations on use of the Covid shot for the fall.
Earlier this summer, Mr. Kennedy fired 17 members of the A.C.I.P. committee who had expertise in infectious diseases and vaccine research. He replaced them with a number of vocal vaccine skeptics, including one member who is leading a review of the Covid vaccines.
States, U.S. lawmakers, drug companies and insurers — as well as consumers — are closely watching the A.C.I.P. panel’s upcoming meeting on Sept. 18 and 19.
In another move, the F.D.A. already limited use of the Covid vaccines to people who are 65 or older or who have an underlying condition that puts them at risk for severe disease. Before a Senate panel earlier this month, Mr. Kennedy irritated some senators, including Republicans, when he asserted that everyone still had access to the Covid shots.
The federal government’s longstanding guideposts on vaccine policy have been embedded in state regulations that vary but often govern access and insurance coverage.
The recent moves by federal health officials to narrow eligibility for Covid shots have led to confusion in many states, with big drugstore chains turning away people seeking the vaccine in several states. That has led some Democratic governors to alter their policies, overriding federal guidelines to allow broader access to the shots.
Irena Hwang contributed data analysis.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
Apoorva Mandavilli reports on science and global health for The Times, with a focus on infectious diseases and pandemics and the public health agencies that try to manage them.
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