Long before he joined the FDA to run the center that regulates vaccines, Vinay Prasad argued against COVID shots for kids. Among his many criticisms of the United States’ approach to combatting the disease, Prasad has insisted that pediatric vaccines have few benefits for kids—and has maintained that the FDA should never have authorized COVID boosters for them, that the CDC should never have recommended those shots, and that “it is malpractice for a doctor to recommend the booster to children.” And he has advocated for the CDC removing the COVID vaccine from the childhood-immunization schedule.
Just two weeks into his tenure as the FDA’s new vaccine czar, Prasad seems to be taking the first steps toward turning this rhetoric into reality.
Yesterday, he and Marty Makary, the FDA’s new commissioner, announced a new framework for COVID-19 vaccines: The agency will no longer green-light new formulations of COVID shots for healthy people under 65, unless companies submit data from new clinical trials that prove the shots’ worth—an unusual ask, experts told me, for vaccines that have already been through the sorts of rigorous studies that scrutinize their safety and effectiveness, and received the agency’s authorization or approval. When describing this shift in an article published in The New England Journal of Medicine, as well as in a livestreamed FDA press conference, Prasad and Makary—neither of whom has formal training in infectious disease or vaccinology—focused primarily on the implications for COVID boosters for young, healthy adults. But experts outside of the agency told me that the policy could also prevent most American children from accessing their initial series of COVID vaccines—essentially guaranteeing that kids will first encounter the virus without protection.
At the press conference, Prasad once again criticized the CDC’s 2023 decision to add COVID vaccines to the childhood-immunization schedule, which currently recommends the shots as a two- or three-dose series as early as six months of age. He and Makary did not, however, explicitly address whether their new framework will ultimately cut healthy, young kids off from an initial series of COVID vaccines. (In theory, children with certain preexisting conditions should remain eligible.) But several vaccinologists, pediatricians, epidemiologists, and vaccine-policy experts told me that the agency’s stance on the matter appeared to be leaning toward yes, at least without new data from companies that will be extraordinarily challenging to collect, if companies try to collect such data at all.
When I contacted the FDA seeking clarification on whether kids will continue to have access to their first COVID vaccines, I did not receive a response. When reached for comment, Emily G. Hilliard, HHS’s press secretary, did not answer my questions about the primary series for kids, but said via email that “a rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden Administration is now over.”
From the earliest days of the pandemic, children have been afflicted by severe COVID at lower rates than adults. “We certainly did not see as much pediatric disease as we saw adult disease,” Buddy Creech, a pediatrician and the director of the Vanderbilt Vaccine Research Program, told me. But kids also were not spared the virus’s worst effects. After the pandemic began, the virus became a top-10 cause of death among American minors, and it has killed more than 1,000 children, many of whom had no preexisting health conditions.
Kids, like adults, are also vulnerable to long COVID, albeit at lower rates. And they have experienced their own unusual, terrifying manifestations of disease, including the inflammatory condition MIS-C. (MIS-C has become much less common in recent years, but is poorly understood and could return with future variants, Creech told me.) Disease that manifests rather mildly now may change as the virus continues to evolve. And generally speaking, among kids, “the younger the child, the higher the risk for severe disease,” Sallie Permar, the chair of pediatrics at Weill Cornell Medicine, told me.
Yesterday, at the press briefing, Prasad noted that COVID hospitalizes children far less often than it does older adults. But diseases also don’t have to be catastrophically deadly to warrant a childhood-vaccination policy, Ofer Levy, the director of the Precision Vaccines Program at Boston Children’s Hospital, told me. The death rate for chicken pox, for instance, is extremely low, but the vaccine is available to, and recommended for, all children—not just those with preexisting conditions. And COVID vaccines for kids, especially in the smaller doses tailored to the youngest age groups, are “among the safest we know of,” Permar told me. Although myocarditis is a rare side effect of COVID vaccines, it is primarily a concern for adolescent boys and young men, rather than very young kids; in general, the shots’ side effects include redness at the injection site, soreness, and fever.
In short, kids are at risk from the virus, and a safe shot can lower that risk. Now, though, per the FDA, apparently “the risk isn’t high enough,” Grace Lee, a pediatrician at Stanford, told me. (During the early years of COVID, Lee chaired the CDC’s advisory committee on immunization practices, or ACIP, which recommended the vaccines for children.)
Prioritizing vaccination for those at highest risk of a particular disease, as the FDA’s new policy would, is sensible. Focused messaging can be an especially powerful way to increase uptake, Creech pointed out. That is sorely needed for people over 65, who are among the groups at greatest risk from the virus and aren’t staying up to date on their shots. Many of the experts I spoke with also said that recommendations that counsel repeat shots for most Americans don’t make as much sense as they used to: Much of the population has immunity from both vaccines and infections, and recent COVID waves have been far more blunted than they were in the past. ACIP was already mulling limiting the recommendations for annual COVID shots to only those at highest risk.
But the question of whether most Americans should be getting COVID shots regularly is fundamentally different from the question of whether healthy kids should be able to get a primary series of shots early in life. Today’s children will likely have to contend with different versions of this virus for the rest of their lives, and to take away to option of gaining protection ahead of disease “is a myopic view of COVID prevention,” Gregory Poland, a vaccinologist and the president of the Atria Research Institute, told me. This country generally does vaccinate against every vaccine-preventable disease that affects children in the U.S., as early as is practical and possible. At the very least, “parents should have an option,” Lee told me.
Without an explicit FDA policy addressing the primary vaccine series for kids, the experts I spoke with said they weren’t sure how quickly access to the shots would dwindle for children. Current COVID vaccines for children could remain available until the next update. But if the CDC alters the recommendations for children, that could tank insurance coverage for the shots, or pediatricians’ willingness to stock them. “I think this next year is going to be full of confusion,” Jason Schwartz, a vaccine-policy expert at Yale, told me. With so much in limbo, manufacturers may not want to keep up production of pediatric shots at all, which are formulated differently and in smaller doses. And pediatric COVID vaccines remain under emergency authorization—which the FDA could still strip entirely.
The FDA has, in theory, laid out a path for future approvals of COVID vaccines, including for healthy young kids—through new clinical trials. But those sorts of studies are expensive and laborious—particularly when they involve children, who get very sick at lower rates than adults and whose parents might not want to enroll them in studies that could offer them only a placebo, Lee told me. The new framework also calls for trials to measure whether vaccines can reduce the risk of symptomatic cases of COVID. But because the shots work best against severe disease, that criterion could set up new shots to fail.
Prasad and Makary stressed that many other countries, including much of Europe, have long since abandoned recommendations that healthy children get COVID shots. But “it’s apples and oranges,” Theresa Chapple, an epidemiologist who is on the board of Vaccinate Your Family, told me. “We don’t have similar health-care systems, and we don’t have similar proportions of healthy people.” At baseline, Americans are at more risk—which warrants more baseline precaution.
In the past, the U.S. government has seen fit to restrict or pull vaccines only under extraordinary circumstances: major new safety concerns, a better immunization option, eradication of disease. And those decisions have generally come only after political leaders consulted multiple scientific experts in the field, which Prasad and Makary chose not to do through their agency’s typical channels. (The FDA’s panel of independent vaccine experts is scheduled to meet tomorrow.) Rather, political appointees with preexisting opinions on COVID vaccines appear to have enacted policy unilaterally. Prasad and Makary publicly went after COVID boosters. But kids’ first defenses against the virus are likely to be that attack’s collateral damage.
