WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the shots more difficult to obtain for children under 5, in particular.
The moves were announced by Robert F. Kennedy Jr., the secretary of Health and Human Services, in a post on the social media site X, while the FDA did not put out a statement. Kennedy portrayed the actions as fulfilling a campaign promise to reverse Covid-era policies while still allowing people to access vaccines.
“I promised 4 things,” Kennedy wrote. “1. to end covid vaccine mandates; 2. to keep vaccines available to people who want them, especially the vulnerable; 3. to demand placebo-controlled trials from companies; 4. to end the emergency.
“In a series of FDA actions today we accomplished all four goals,” he continued.
Covid vaccine authorizations for all three available vaccines, Kennedy said, would now only be for higher-risk individuals, including those over 65 and those who have risk factors for developing severe Covid. Kennedy said that the Moderna vaccine is approved for those older than 6 months, the Pfizer/BioNTech vaccine for those older than 5 years, and the Novavax shot for those older than 12. Pfizer and Moderna confirmed the approvals of their booster shots in separate statements.
“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy wrote. “The American people demanded science, safety, and common sense. This framework delivers all three.”
The Centers for Disease Control and Prevention lists more than two dozen conditions as increasing a person’s risk for severe outcomes after Covid-19 infection, including asthma, cancer, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, and mood disorders such as depression.
The FDA also ended the emergency use authorization for Covid-19 convalescent plasma, according to an HHS spokesperson. The blood product is now available from manufacturers under the standard approval process.
As part of the approvals, the FDA is requiring several new clinical trials of Pfizer’s shots. It previously imposed similar demands on Moderna.
Pfizer said shipping of its vaccine will begin immediately and that it can provide a robust supply of the shots to pharmacies, hospitals, and clinics across the country. Moderna said its updated vaccines will be available within days.
“Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year,” said Stéphane Bancel, Moderna’s CEO, in a statement. “We are proud to help ensure Americans will have the latest protection against currently circulating strains this respiratory virus season.”
The federal moves have the effect of limiting the availability of Pfizer’s Covid-19 vaccine for children under age 5. The shot was previously available to children as young as 6 months via the emergency use authorization. That could make it more challenging for healthy children in that age group to receive Covid shots this fall.
The FDA approved Moderna’s vaccine for children as young as 6 months in July, but only for those with an underlying condition. Pfizer’s shot, which was developed in partnership with BioNTech, was seen as the main option for parents wishing to inoculate their young, healthy children against Covid.
It’s unclear how willing doctors might be to offer Moderna’s shot to young children off-label, and whether insurers will continue to pay for the immunizations.
Agency officials, like FDA Commissioner Marty Makary and top vaccine regulator Vinay Prasad, have argued that the risks of Covid vaccines outweigh the benefits for healthy children and noted that uptake of the shots, both for children and adults, has been low in recent years. Prasad overruled dozens of career scientists to limit Covid vaccine approvals three times in the past few months, including Moderna’s vaccine.
The approvals reflect the FDA’s new framework for Covid vaccines and Kennedy’s decision in May to stop recommending the shots for healthy children and pregnant people.
The restrictions, however, do not align with some experts’ analysis of the risks and benefits of the Covid vaccine. The American Academy of Pediatrics called them “deeply troubling” and said the shots should be available for all children ages 6 months through 23 months.
Covid is more likely to send babies to the hospital compared to older kids, according to data presented to the Centers for Disease Control and Prevention in June. Last week, the American Academy of Pediatrics recommended Covid shots for all children between 6 months and 23 months, as well as children over 2 at risk for severe disease. The Vaccine Integrity Project, a new group formed by public health experts trying to promote vetted vaccine information to counter the vaccine-skeptical Trump administration, echoed the AAP’s recommendations.
Hundreds of millions of people have received the Covid vaccine, and outside of an increased risk of myocarditis, researchers have seen few major side effects.
Johns Hopkins vaccine expert Anna Durbin said the rate of deaths and severe illness due to Covid are low in younger populations. But the disease still comes with risks, and is not pleasant or convenient for kids to have.
“Bad things happen, and we know that these vaccines are incredibly safe in this population,” said Durbin, who is an investigator on a Lyme disease vaccine trial that’s sponsored by Pfizer. “They can get sick, and it can affect parental leave and work and all of that.”
After the AAP issued its vaccine recommendations, Kennedy attacked the group on social media, accusing the organization of bias because it has accepted donations from pharmaceutical companies. The AAP and the CDC’s Advisory Committee on Immunization Practices have historically been in sync. But in June, Kennedy fired all 17 ACIP members and reconstituted the panel with seven appointees who have a documented history of vaccine skepticism.
The result is a balkanization of vaccine policy, with parents and health care providers forced to choose between conflicting recommendations when deciding whether to vaccinate children.
As part of the approvals, the FDA will require a raft of clinical trials from Pfizer. Like Moderna, Pfizer and BioNTech have committed to a large randomized controlled trial of their Covid vaccine in adults aged 50 through 64 years without conditions that put them at high risk for Covid-19. The exact design of the study was not disclosed, but the FDA’s approval letter said that the study should start by Nov. 30, with interim results by May 31, 2026, and final report completion by January 30 2027. An approval letter sent to Moderna said its similar efficacy study should also begin Nov. 30, complete by January 31, 2027, and have a final submission by the end of 2028.
The FDA has also required Pfizer to conduct another large placebo-controlled study examining whether patients who receive the vaccine ever continue to have SARS-CoV-2 spike antigen, the protein produced by the vaccine, long after it would be expected to have disappeared and whether they develop self-reported symptoms of “post-Covid-19 vaccination syndrome” or long Covid. A controversial study said that in rare cases patients develop such a syndrome and that in a few there was detectable spike protein long after the vaccine was received. Many researchers have been skeptical of the result. That study is to be completed by April 30, 2027.
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