The US Food and Drug Administration is examining rare cases involving the deaths of young people after they received Covid vaccines, under pressure from Health Secretary Robert F Kennedy and his allies for public disclosure of more information.
The agency said it was also seeking undisclosed details about the safety of the shots for pregnant women, reports The New York Times.
The FDA’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 at the bidding of Kennedy, who has repeatedly suggested that the inoculations are deadly.
Some of his anti-vaccine allies have been pressuring the government for years to delve deeper into the databases that include reports of harmful effects from the Covid shots.
The FDA’s efforts could ratchet up tensions over the vaccine and tarnish the legacy of President Donald Trump’s championing of vaccines during the pandemic. He has received widespread, bipartisan credit for Operation Warp Speed, the government-financed programme that rapidly delivered millions of lifesaving Covid vaccines using mRNA technology.
The agency’s reviews were in anticipation of an influential Centres for Disease Control and Prevention (CDC) committee which will discuss the Covid shots and issue recommendations for this winter that could limit insurance coverage and availability in some states.
At the meeting this week, Dr Tracy Beth Hoeg, an FDA official who previously advised Dr Joseph Ladapo, the Florida Surgeon-General and vaccine critic, is expected to present details about roughly two dozen deaths in children that were attributed to the shots.
Dr Marty Makary, the commissioner of the FDA, said this month that “nobody really has good data” that could answer some specific questions, including whether there had been cases last year where 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 were never made available before, including adverse event data – that is, young people who have died from the Covid vaccine,” Makary said. “And we’re going to make that available to the medical community in full transparency, because this is the question Americans are asking.”
Andrew Nixon, a spokesman for the Department of Health and Human Services, said the FDA and CDC staff routinely analyse reports of vaccine harm and other safety monitoring data, and those reviews are being shared with the CDC committee.
“Until that is shared publicly, any of this should be considered pure speculation,” he said.
There is no official figure from federal health agencies on US 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 hospitalisation from Covid during the first six months of life is similar to that of adults aged 65 to 74.
Hoeg’s review 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 CDC data.
The agency reviews appear to be in response to mounting claims, especially from Kennedy, that data have been hidden from the public.
Drug makers are required to send all reports of harm related to drugs or vaccines to the FDA, 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 under 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 flu. Boys and young men aged 12 to 24 who receive the Covid shots were known to be at increased risk of myocarditis.
The CDC 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 FDA were complicated. One describes a 17-year-old girl who had Covid and recovered in August 2021. In September that year, she received two doses of the Pfizer vaccine.
In late October, she was admitted to an emergency unit 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 FDA report says, was “possible acute myocarditis”.
Earlier this month, Makary said on CNN that his agency’s review of such cases had shown that “there have been children who 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 FDA vaccine regulator who was fired early in 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,” 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 FDA review is being led by Dr Vinay Prasad, the top vaccine official at the agency, an academic oncologist and epidemiologist. He often criticised 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 FDA has sought more detail on the birth defect cases in the Pfizer study.
The effort to zoom in on individual cases of harm is reminiscent of 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, he 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 programme so that vaccine injuries will be reported, they will be studied, that individuals who suffer them will not be denied or marginalised or vilified or gas-lighted,” he said last week.
During the meeting this week (Wednesday and Thursday), members of the CDC’s Advisory Committee on Immunisation Practices are expected to issue recommendations on use of the Covid shot for this winter.
States, US lawmakers, drug companies and insurers – as well as consumers – will also be closely watching the meeting.
The New York Times article – F.D.A. Reviews Reports of Covid Vaccine Deaths (Restricted access)
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