FDA Expands Covid Vaccine Inquiry to Adult Deaths

The agency claimed that 10 children’s deaths were linked to the shots, although it did not release evidence to support the assertions.

The Food and Drug Administration has expanded its investigation of deaths possibly linked to the Covid vaccine to include adults as well as children, according to a Trump administration official.

The inquiry began in September, spurred by Health Secretary Robert F. Kennedy Jr.’s repeated claims that the coronavirus vaccine is dangerous and deadly despite the widespread scientific consensus that the shots are safe.

At the time, the agency said that it was looking into children’s deaths, in apparent response to the vocal concerns of vaccine skeptics who are allies and supporters of Mr. Kennedy.

“F.D.A. is doing a thorough investigation, across multiple age groups, of deaths potentially related to Covid vaccines,” Andrew Nixon, a spokesman for the Department of Health and Human Services, said on Tuesday.

The broader review follows a memo in late November by Dr. Vinay Prasad, the F.D.A.’s top vaccine regulator, who informed staff members that the agency had linked about 10 children’s deaths to the Covid shots. He highlighted the dangers of myocarditis, or inflammation of the heart muscle, which the agency has for years cautioned is a rare but worrying side effect, especially among teenage boys and young men.

Dr. Prasad offered no evidence in the memo to back the findings on the deaths, and the agency did not release any details to buttress the claims.

Many public health experts have responded by emphasizing that the virus itself has killed 1.2 million Americans, including more than 2,000 children.

They also raised alarms over Dr. Prasad’s outline in the memo of much broader changes to the vaccine approval process, which is aligned with Mr. Kennedy’s agenda to overhaul longstanding policy on vaccines. Some experts argue that these significant changes will further undermine confidence in vaccines, as infectious diseases in the United States continue to spread.

This year, measles outbreaks across the United States have reached more than 1,800 confirmed cases. More than 90 percent of the people who fell ill were not vaccinated, according to the Centers for Disease Control and Prevention. Pertussis, or whooping cough, cases have also soared. Three infants died of the virus this year in Kentucky, and state officials said that neither the mothers nor the infants had been vaccinated against pertussis.

Just last week, an influential C.D.C. vaccine committee recommended the reversal of the decades-long practice of inoculating all newborns against hepatitis B, an infectious disease that can cause serious liver damage.

The new review into possible links between the Covid shots and adult deaths was earlier reported by Bloomberg News.

Former agency officials have said that they did not ignore concerns about the Covid vaccine. They said they had reviewed reports of childhood deaths filed with the agency, by examining autopsy reports and medical records.

“To the best we could see, these vaccines were not associated with the deaths of children,” Dr. Peter Marks, the agency’s former top vaccine regulator, said in September, when news of the review first came out. “Is it possible that a death could have occurred that was related to the vaccines? Yes, I guess, possible.”

Some adult deaths related to Covid vaccines were widely known, including at least three attributed to a rare blood-clotting complication from the Johnson & Johnson vaccine. Federal authorities initially paused and later stopped use of that vaccine in the United States.

Among the broader changes sought by Dr. Prasad is a halt to updating well-tested vaccines to match circulating strains of viruses like the flu without time-consuming studies. Such a requirement could make such vaccines obsolete before they are approved.

After Dr. Prasad’s memo emerged, 12 former F.D.A. commissioners published an article in the medical journal NEJM, saying the changes “undermine the public interest.”

“They are the latest in a series of troubling changes at the F.D.A., including substantial departures of F.D.A. staff that could diminish both the F.D.A.’s strength and Americans’ health and safety,” the commissioners wrote.

It remains unclear whether the agency will formalize the proposed changes into regulations or a guidance, the way it typically describes such changes to pharmaceutical makers.

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