Usha Lee McFarling , 2025-05-20 22:07:00
A new framework for Covid-19 vaccines announced by Food and Drug Administration leaders Tuesday suggests the agency will no longer approve new Covid vaccines for healthy individuals under 65, including babies, without data from new randomized clinical trials showing their benefit.
The plan — described in a commentary in the New England Journal of Medicine, followed by a live stream on YouTube — created confusion among physicians about what it means for young children. While much of the language discussed the need for more data supporting the ongoing use of annual booster shots, it also referred to a lack of evidence for children as young as 6 months, who currently get a two- or three-dose “primary” series of vaccinations.
When asked for clarification, a spokesperson for the department of Health and Human Services did not say how the new approach would affect childhood vaccinations. But STAT was told the framework does not apply to vaccines already on the market, meaning healthy adults and children could still receive existing Covid shots. New trials would only be required for new vaccines or new formulations made to target new viral strains.
It remained unclear if the framework encompasses only new Covid boosters, or also new primary vaccinations for children, and how long existing shots for children, sold by Pfizer and Moderna and approved under emergency use authorizations, would remain in force since Covid is no longer considered an emergency.
The announcement by FDA Commissioner Marty Makary and the agency’s top vaccine regulator left physicians and infectious disease specialists with numerous questions, including how long healthy adults might continue to receive Covid vaccines, whether the FDA has the authority to decide who is eligible for vaccines, how people considered high risk would have their eligibility established for insurance coverage, and whether health care workers and others who get vaccinated to protect high risk individuals would continue to be eligible for vaccines.
The possibility that Covid shots would become unavailable for kids alarmed pediatricians. “I see children admitted to the hospital with Covid and they’re not all high risk children — including those who go to intensive care units,” said James Campbell, a professor of pediatrics and infectious diseases specialist at the University of Maryland. “If we have safe and effective vaccines that prevent illness, we think they should be available.”
Campbell, who is also vice chair of the committee on infectious diseases at the American Academy of Pediatrics, said he took offense at the tone and title of the commentary — “An Evidence-Based Approach to Covid-19 Vaccination” — saying it suggested “everyone who has been working on this for five years hasn’t been thinking it through.”
Decisions on vaccines, he said, should be decided by working groups that sift through the evidence and debate. “It should not be that two people make the decision,” he said, referring to Makary and Vinay Prasad, who heads the FDA Center for Biologics Evaluation and Research, which evaluates vaccine safety.
In a FDA livestream, Prasad said he remained unconvinced of the need for Covid vaccines for children. “It’s a decision that I think went far beyond the available evidence,” he said of adding Covid-19 to the routine childhood vaccination schedule in 2023. (Covid vaccinations have been recommended for increasingly younger age groups since 2021.)
While current data show children under age 4 have a greater risk of a serious illness than older kids, Prasad showed statistics suggesting that these young children were at much lower risk of severe disease from the virus than people over 65, for which Prasad said no new clinical trials will be required. While people over 50 are also at higher risk for severe disease, Prasad said clinical trials would be needed to prove benefit outweighed risk in that age category.
Making sure children have immunity through early vaccination is something many physicians support, however, especially because most infants have not been exposed to the virus. “I think there is strong data to suggest Covid should be part of routine childhood vaccinations,” said Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security, “We vaccinate kids for things that have less morbidity and mortality than Covid, like chickenpox for example.”
Emergency physician Jeremy Faust of Boston’s Brigham and Women’s Hospital, who hosted his own livestream to discuss the new framework as soon as it was released, said it was critical to make sure “immune-naive” infants 6 months and older receive the vaccine.
“These infants are high risk and they deserve immunity. No parent deserves to have their child hospitalized, have lung damage, have deaths … for want of a vaccine that has been proven to be safe and effective,” he said, adding that cost/benefit scenarios for infants should err on the side of caution.
“I don’t want to tell people their kid had to be intubated for Covid-19 because we were a little bit cheap,” he said.
Prasad did not take questions from reporters during the live-streamed town hall. Campbell said the American Academy of Pediatrics would be working with the FDA to get more information and would communicate any changes to its members and the public but that nothing was likely to change immediately. “At this point, we don’t know what it means,” he said. “It’s going to be some time before we understand.”
Prasad called himself, based on his years treating immunocompromised cancer patients, “an extreme pro-vax person,” but said he was against a “rubber stamp approach” to approving Covid vaccines for all populations without evidence their benefits outweighed their risks.
Aside from the issue of routine childhood vaccinations, Adalja said he found the new framework, with its approach of targeting vaccines based on risk, “reasonable.” He said such targeting aligns with what is being done in other countries like Canada and the United Kingdom. Many vaccine experts have said that because so many adults have some level of immunity to Covid through vaccines, infections, or both, it is time to consider recommending Covid vaccines to everyone and moving to a more targeted approach.
Others were more concerned about the broader impact of new restrictions. One question is what they will mean for people who live with or interact with high-risk individuals, such as those on chemotherapy or who have received organ transplants. “My vaccination could save the life of my visitor,” said Faust.
Prasad said that he did not see this as a valid reason for vaccination and said that the RSV vaccine was offered only to high-risk individuals and not those who interact with them. “We are bringing Covid vaccine policy in line with RSV,” he said.
Another category where the impact was unclear was on health care workers. Celine Grounder, an infectious disease specialist and epidemiologist, said during Faust’s livestream that she routinely gets Covid-19 boosters and annual flu vaccines, “not really for myself, it’s for my patients. The vaccine reduces the risk of transmission and infection.”
Prasad did not mention eligibility for vaccines for health care workers. He noted a low uptake of the Covid vaccine — 1 in 6, among health care workers. Campbell, of Maryland, said that low uptake was not a reason for vaccines not to be recommended and that new vaccines often had low uptake. “We shouldn’t make vaccine recommendations based on opinion polls,” he said.
The new vaccine framework could disproportionately affect Black, Hispanic, and Native American communities, which suffered much higher hospital admission and death rates from Covid-19 and also have less access to health insurance and services, some doctors said.
“Many of these communities work in frontline service jobs which raise their levels of exposure. Restricting access to Covid vaccines will make it more challenging for people already at the margins who do not meet the new stricter eligibility criteria to be able to get vaccinated to protect themselves,” said Boghuma K. Titanji, an infectious disease physician and assistant professor of medicine at Emory University. “Without doubt, the downstream effects will be a further widening of the health care disparities.”
People with long Covid said evidence showing that vaccination and boosters reduce the risk of long-lasting post-Covid symptoms were ignored by the FDA leaders. The condition was not mentioned in the NEJM commentary nor during the town hall.
Prasad, along with his boss Makary, emphasized that one reason they were reining in eligibility for Covid vaccines was because the push to use them widely was causing mistrust in other more critical vaccines, like the one for measles.
But Tim Caulfield, a professor of health law and science policy at the University of Alberta and an outspoken critic of misinformation, pushed back on such thinking. “The logic seems twisted,” he said. “Politically fueled misinformation created distrust, so now we are going to push a vaccine policy that seems to legitimize that distrust? How does that help?”
