Come this fall, only older Americans and those with chronic health problems may be urged to get the Covid shot — assuming the vaccine is available at all.
For years now, scientific advisers to the Centers for Disease Control and Prevention have been debating whether to continue to recommend that Americans 6 months of age and older be immunized, or to switch to a so-called risk-based strategy targeting only the most vulnerable, as is the practice now in most other countries.
The advisers are expected to decide on a way forward at a meeting in June. But the debate may have become irrelevant. New requirements for clinical testing of vaccines, announced earlier this month, may delay the availability of shots that had formerly been updated annually without complicated trials.
“Substantial updates to existing vaccines — such as those related to seasonal strain changes or antigenic drift — may qualify as ‘new products’ and therefore require additional clinical evaluation,” the Department of Health and Human Services said in a statement.
That category includes the Covid shots and “may” even include the seasonal flu vaccine, according to Andrew Nixon, a spokesman for H.H.S.
The Food and Drug Administration has already asked Novavax for more clinical data before approving its Covid vaccine. (Currently it has emergency use authorization, not full approval, for people aged 12 and older.)
“We want to see vaccines that are available for high-risk individuals, and at the same time we want some good science, we want some good clinical data,” Dr. Marty Makary, who heads the agency, told reporters at a conference on Thursday.
Officials in Washington have also been asking pointed questions of C.D.C. scientists about Covid’s toll on children under 12, an indication that they may be considering an end to the use of the vaccine in that age group, according to an official who did not wish to be identified for fear of retribution.
The Wall Street Journal reported on Thursday that H.H.S. plans to stop recommending the Covid vaccine for children and pregnant women altogether, citing people familiar with the matter.
In May 2021, Robert F. Kennedy Jr. sought to rescind authorization for the shots in a petition to the F.D.A. He has said, falsely, that the vaccines had killed more people than the virus.
The leaders he has installed at the agencies he leads, including Dr. Makary, have also been outspoken critics of annual Covid shots, particularly for children.
On the latter point, many public health experts agree, including some advisers to federal agencies. They have suggested for years now that annual booster shots might offer only marginal benefits to relatively younger, healthy Americans.
“I think what Dr. Makary is saying is that if everybody already has immunity to the virus, then maybe the vaccine doesn’t add that much, or maybe it adds something only in certain subpopulations,” said Dr. Philip Krause, a former F.D.A. vaccine regulator. “I think it’s a reasonable question to want to know the answer to.”
(Dr. Krause resigned from the F.D.A. in the fall of 2021 because he felt there was not enough evidence to support Covid booster shots for adults.)
The C.D.C. already collects data on the benefits of the Covid vaccines, which have decreased over time as more Americans gain greater immunity to the coronavirus.
But the vaccine should remain available to some people, including adults 75 and older, who remain at high risk, Dr. Krause and other experts noted.
“In my opinion, the data from the C.D.C. provide pretty strong evidence that there are some people who are still benefiting quite a bit from the vaccines,” he said. “There are still more Covid deaths than we would like.”
Mr. Kennedy has falsely asserted that none of the vaccines routinely offered to children have been tested in placebo clinical trials, prompting sharp rebuttals from several groups of scientists, and from Senator Bill Cassidy, Republican of Louisiana, whose vote cinched Mr. Kennedy’s nomination as health secretary earlier this year.
Some experts fear that the new federal limits are just the first steps in a campaign to undermine the use of all vaccines, including those in the childhood immunization schedule, by raising doubts about their safety and imposing requirements that make it untenable for companies to keep making them.
“I think that we are in the midst of watching the vaccine infrastructure being torn down bit by bit,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the F.D.A.
Tara Smith, an epidemiologist at Kent State University College of Public Health who tracks the anti-vaccine movement, said there was jubilation among some groups that all vaccines, including the decades-old flu vaccine, might be challenged.
“I think everything is a target,” she said.
Covid fatalities have plummeted each year since the start of the pandemic, although there were still roughly 1,000 deaths per week during last winter’s peak. The vast majority occurred among adults aged 75 and older.
Earlier this month, federal officials sent the C.D.C. an urgent request for the annual number of Covid-related deaths in children under 12, according to an official with knowledge of the matter.
In the year ending in August, the agency reported 150 pediatric deaths, a number comparable to deaths among children in a typical flu season.
“We all, I think, support the pediatric use of flu vaccines,” said Michael Osterholm, an infectious disease expert at the University of Minnesota. If Covid is roughly as risky to children, “I find it hard not to at least allow the vaccine to be available.”
The number of Covid deaths in children seems low only when compared with fatalities in adults, said Sean O’Leary, chair of the infectious disease committee for the American Academy of Pediatrics.
“That’s the wrong way to look at it, because pediatric deaths are actually quite rare,” he said. If the vaccine were withdrawn for young children entirely, “I would have a big problem with that. Those kids do remain at higher risk for hospitalization.”
Dr. Krause said he was puzzled that the pediatric vaccine had not been moved to full approval from emergency authorization, while the adult versions were fully approved years ago by the F.D.A.
It may be that the F.D.A. has access to data that has prevented them from approving the shot, he said. “That being said, I think there probably are some children who would benefit from the vaccine,” he said.
The F.D.A. has not elaborated on what additional testing of Covid vaccines might entail. But officials may offer some clarity before the agency’s scientific advisers meet next week to discuss vaccines for the fall.
It would be unethical to offer a placebo to participants in a randomized trial if the virus still poses risks. And the results of any new trials would not be available in time for the fall, experts noted.
“In order to to create new requirements for vaccines, there would have to be evidence that that would have any benefit for the public,” said Dr. Eric Rubin, one of the F.D.A.’s advisers and editor in chief of the New England Journal of Medicine.
“The issue, of course, is when you go into this having decided what the answer is, rather than looking at the data objectively,” he said.
Some of the C.D.C.’s advisers had mixed feelings even about moving to risk-based vaccine recommendations.
Such guidelines make sense in countries with universal health coverage, they said. But in the United States, insurance companies are not required to pay for an immunization that is not recommended by the C.D.C.
That may leave a vaccine that is too expensive for some who need it and are not explicitly included in a risk-based recommendation. A blanket recommendation may be more effective, some experts said.
“Vaccinations for children who have never been vaccinated, people with risk factors, are critically important,” said Dr. Denise Jamieson, one of the C.D.C. advisers.
It’s unclear whether the advisers retain much sway, however. Recommendations they made in April for use of several vaccines, which are typically promptly accepted by the C.D.C., have still not been endorsed by an agency leader.
The C.D.C. does not have a permanent director. Matthew Buzzelli, whom Mr. Kennedy pointed to on Wednesday as an acting director, is an attorney. Another official at H.H.S., Dr. William Archer, has sent the C.D.C. multiple questions about the advisers’ recommendations.
Dr. Archer has repeatedly discussed the “limitations” of the Covid vaccine on social media, according to Reuters.
In one query viewed by The New York Times, he told agency staff he needed “more justification” for a recent recommendation to expand use of the respiratory syncytial vaccine.
Apoorva Mandavilli reports on science and global health, with a focus on infectious diseases, pandemics and the public health agencies that try to manage them.
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