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In the past two weeks, U.S. public health authorities have skirted normal procedures and announced two major policy changes that will likely reduce access to COVID-19 vaccines and restrict use to higher-risk populations.
On May 20, the Food and Drug Administration announced a new regulatory framework that suggests that without new placebo-controlled trials, the agency will only approve updated COVID-19 vaccines in the future for people 65 and older and those with at least one risk factor for severe COVID-19.
On May 27, Health and Human Services Secretary Robert F. Kennedy Jr. said in a video posted on X that the Centers for Disease Control and Prevention was no longer recommending a COVID-19 vaccine for healthy children or healthy pregnant women. Previously, the CDC recommended COVID-19 vaccines for everyone 6 months of age and older.
In both cases, officials skipped the regular process for such decision-making, which typically includes guidance from advisory committees and input from vaccine makers, scientists and regular people during meetings that are livestreamed and open to the public.
“These were announcements, not actual discussions,” Dorit Reiss, a professor of law at University of California Law San Francisco who specializes in vaccine law and policy, told us. “They both can have the effect of making it harder for people who want COVID vaccines to get them.”
Both decisions also leave many outstanding questions that the agencies have not yet clarified. Here, we explain what we know — and don’t — about these new COVID-19 vaccine policies.
Update, June 20: HHS circulated an “FAQ” document to lawmakers with justifications for changing COVID-19 vaccine recommendations, but the document misrepresented scientific studies and made unfounded claims about vaccine safety. For more, read “HHS ‘FAQ’ Distorts Data on COVID-19 Vaccination During Childhood and Pregnancy.”
- What did the FDA announce?
- What did Kennedy announce?
- How does this change who can get a COVID-19 vaccine?
- How do both policy changes diverge from the standard vaccine recommendation process?
- What do experts think about the modified CDC recommendations?
- What do experts think of the FDA’s new framework?
What did the FDA announce?
FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the agency’s division that regulates vaccines, announced the new framework for COVID-19 vaccines in a livestreamed video and commentary published in the New England Journal of Medicine on May 20.
Citing COVID-19 vaccine recommendations from other high-income countries — none of which has a universal recommendation — along with what they described as uncertainty about whether healthy, younger people benefit from the vaccines, the two officials indicated that future COVID-19 vaccines would only be approved for people 65 years and older and those with at least one risk factor for severe COVID-19.
Those approvals, they explained, would be based on immunogenicity data, or evidence that the vaccine generates an antibody response in people. That’s a slightly higher bar than the evidence required for last year’s updated shots, which relied on antibody data in animals in addition to other accumulated evidence. (With earlier updates, companies have sometimes submitted clinical antibody data, but given that the change to the vaccine is so minor, the FDA did not require clinical data, similar to how the agency handles seasonal influenza vaccines.)
For everyone else, the officials wrote in their commentary, the “FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes” before approval.
The regulatory change is similar to the FDA’s recent, more limited approval of Novavax’s protein-based COVID-19 vaccine for people 65 and older or those with at least one underlying health condition. According to reporting by Politico and the Wall Street Journal, political appointees delayed and intervened in the approval.
The new framework does not apply to the COVID-19 vaccines currently on the market. It only applies to updates or new formulations of the vaccines. For the 2025-2026 season, the FDA is advising that vaccines continue to target the JN.1 lineage, but says that it prefers an update to a specific subvariant. Last year, the FDA authorized and approved updated vaccines in late August.
What did Kennedy announce?
A week later, in a 58-second video also featuring Makary and National Institutes of Health Director Dr. Jay Bhattacharya, Kennedy made another announcement.
“I couldn’t be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,” Kennedy said.
“It’s common sense and it’s good science,” Bhattacharya added, even though no evidence was provided.
Notably, Kennedy’s announcement is at odds with the new FDA framework, which includes pregnancy as a high-risk condition for which updated vaccines would be approved without new trials.
Kennedy’s announcement also does not entirely match with how the CDC ultimately updated its childhood immunization schedule. The schedule is a timetable for when recommended vaccines should be given and dictates which vaccines insurance providers are required to cover without a copay under the Affordable Care Act.
Although Kennedy said in the video that the policy was effective on May 27, the CDC did not update the schedule until the evening of May 29. Instead of removing the COVID-19 vaccines for “healthy” children, however, the schedule changed the recommendation for all children without compromised immune systems to one of shared clinical decision-making, meaning such children “may” receive a vaccine after consultation with their health care providers. For children who are moderately to severely immunocompromised, the full recommendation to receive a vaccine remains.
Kennedy never said what he meant by “healthy” children, but previously, Makary and Prasad have suggested that the FDA views them as children without a risk factor for severe COVID-19. Many children have one or more risk factors but are not necessarily immunocompromised.
For pregnant adults, the CDC schedule now lists the vaccine as “no guidance/not applicable.”
HHS did not respond to a detailed list of our questions trying to clarify various aspects of the different policies.
“The old COVID-19 vaccine recommendations for healthy children under 18 and for pregnant women have been removed from the CDC vaccine schedule,” a spokesperson said in a statement. “Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship. If a parent desires their healthy child to be vaccinated, their decision should be based on informed consent through the clinical judgement of their healthcare provider.”
Reiss told us the HHS statement was “pretty disingenuous,” noting that “the decision to vaccinate is always a personal one, and most people do it through their doctor.”
Following news coverage that the CDC schedule retains a modified recommendation for children, HHS has since insisted in a post on X that the media are wrong and that the schedule is “very clear” that the vaccine “is not recommended” for pregnant women or healthy children.
However, as we said, the recommendation for now is one of shared clinical decision-making for kids who are not immunocompromised.
How does this change who can get a COVID-19 vaccine?
Immediately, there may not be a large change. But soon, some kids (or their parents) and pregnant people may have to pay out of pocket for a vaccine, and some providers may be more hesitant to recommend the shots to patients. And in the fall, if the vaccines are updated under the new framework, that is likely to be the case for even larger swaths of the population.
The reason for the intense focus on the language of the policy — and whether the vaccines are truly removed from the CDC’s immunization schedule or not — is because removal from the schedule would mean that insurers are no longer required to cover the vaccines with no cost-sharing under the Affordable Care Act.
People without a recommendation could still get them, Reiss said, but they would need to pay out of pocket if their insurer decided to drop coverage of the vaccine. CVS currently charges around $200 for a single dose.
Some insurance companies might still cover the shots if it’s cost-effective for them. “But that would be up to the insurance company,” Reiss said.
Under the current language used in the amended CDC schedules, Reiss said, insurance companies are no longer required to cover the shots for pregnant adults. Insurers are still required to cover vaccines recommended under shared clinical decision-making, although she said that in practice, that doesn’t always happen.
Come fall, the FDA appears poised to approve updated vaccines only for higher-risk groups, since it’s not possible for any new trials with younger, healthier people to have been completed, even if companies decide to start them.
Prasad and Makary have emphasized that the list of medical conditions the CDC uses to define high risk — which includes pregnancy, obesity, depression, physical inactivity and being a current or past smoker — is “vast” and estimated to include around 100 million to 200 million Americans.
“This is a tremendously broad category,” Prasad said in the livestreamed video. “At-risk Americans can be reassured that they will be covered by such approvals.”
Experts told us updated vaccines could still be prescribed off-label for younger people who aren’t high risk, but if there isn’t a CDC recommendation, then insurance coverage won’t be required. And if the vaccines are both not licensed and not recommended, Reiss said, “more doctors may hesitate to prescribe” them. The vaccines may also be harder to find, and pharmacies, for example, may not be willing to administer them.
Charlotte Moser, co-director of the Children’s Hospital of Philadelphia’s Vaccine Education Center and a member of the CDC’s outside Advisory Committee on Immunization Practices, told us in an email that it’s “possible that the ACIP would vote to have the vaccines used ‘off-label,’ which would mean using them differently than the way the FDA licensed them.”
But the ACIP recommendations would need to be accepted by the director of the CDC, and currently, there doesn’t appear to be an acting director. The recommendations ACIP made in its last meeting in April went directly to Kennedy, and so far, he has only accepted one of three recommendations, Moser said.
Even if the vaccines aren’t updated to target a new variant, the CDC recommendations could still shift.
“I don’t quite know what CDC will do and how this will go,” Reiss said. “It’s a mess.”
How do both policy changes diverge from the standard vaccine recommendation process?
Typically, the FDA is in charge of licensing vaccines and giving general indications for their use, and the CDC’s job is to make tailored recommendations about who should use them, when and how. And as we’ve mentioned, both the FDA and the CDC have panels of independent, outside experts that inform those decisions.
But in this case, both policy changes were made without the input of the agencies’ advisory committees, even though both ACIP and the FDA’s Vaccines and Related Biological Products Advisory Committee were scheduled to meet to discuss COVID-19 vaccine recommendations in the near future — on May 22 for VRBPAC and late June for ACIP.
Dr. Kathryn M. Edwards, a retired vaccinologist and pediatrician and former member of the VRBPAC and ACIP, wrote in a STAT opinion piece that the way in which the FDA changed its regulatory framework “is in stark contrast” with the standard process.
“The usual practice is to provide Draft Guidance Documents, comprehensively outlining specific requirements in the Federal Register, and inviting a period of public comment so experts in a broad range of fields, including immunology, biostatistics, and clinical care, can add their perspectives. Then the FDA finalizes the document and posts it to the FDA website,” she wrote.
“The FDA guidance presented in the NEJM was not released in the Federal Register, did not invite comment, and provided only a general outline for Covid-19 vaccine licensure. The report lacked detail, and a clear blueprint was not provided,” she continued.
The decision to change the CDC vaccine schedules also circumvented the way in which vaccine recommendations are typically made. As Reiss told us when we reported on Kennedy’s intention to remove the COVID-19 vaccines from the childhood vaccination schedule, the decision should have been made after discussion with ACIP.
“This decision bypasses a long-established, evidence-based process used to ensure vaccine safety and ignores the expertise of independent medical experts, including members of CDC committees who are examining the evidence regarding the vaccine to make recommendations for the fall,” said Dr. Sean O’Leary, an associate professor of pediatrics at the University of Colorado and chair of the American Academy of Pediatrics Committee on Infectious Diseases, in a statement sent to us by the AAP.
By not following the established procedures, the HHS agencies are vulnerable to legal challenges, Reiss told us.
“This is really bad administrative procedure, even before we talk about circumventing ACIP,” she wrote on social media. Under administrative law, she said, agency decisions have to meet certain criteria. For instance, they must include explanations of the agency’s fact-finding and how the facts support the decisions.
On June 3, Reuters and CBS News reported that a pediatric infectious disease expert at the CDC who had helped lead ACIP’s working group resigned from her position. “My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population,” she wrote in an email to colleagues, “and that is not something I am able to continue doing in this role.”
What do experts think about the modified CDC recommendations?
Physicians’ and other experts’ confusion and frustration have been followed by relief after the CDC did not go through with Kennedy’s stated plan of removing the COVID-19 vaccine from the childhood immunization schedule for healthy children, which would have removed the requirement that the vaccine be covered by insurance.
While the guidance “allows families to continue to choose the Covid vaccine, how we got here is troubling,” the AAP said in a post on X.
As we’ve reported, and as the AAP noted in a statement, ACIP was already leaning toward shifting from a universal recommendation to a risk-based recommendation for certain populations, recognizing that the vaccine is significantly more beneficial to older people and those with conditions that put them at higher risk.
Children are typically at much lower risk of getting severely ill from COVID-19 than older adults, and some doctors do not think healthy kids need to receive annual doses. At the same time, data presented at the last ACIP meeting in April shows COVID-19 does still kill and hospitalize children, including those without any risk factors. There is also evidence that the vaccine protects children and adolescents from long COVID.
At the last ACIP meeting, nearly 90% of ACIP work group members who supported a risk-based recommendation also supported allowing anyone who wanted protection from vaccination to receive a vaccine.
Experts have pushed back on changing the recommendation for pregnant people and have also been particularly concerned about babies and other young children receiving an initial series of shots, given evidence that very young children are among the most affected by COVID-19.
In a LinkedIn post, Moser pointed out that in practice, the shared clinical decision-making recommendation “often does not translate into a focus on individual benefits” and is “particularly troublesome” for high-risk children, “who now have a weaker recommendation than adults with similar conditions,” and for unvaccinated children.
“Every year in this country, 3 to 4 million children are born and don’t have any immunity to this virus,” she told us in an interview.
In the past, experts have argued that shared clinical decision-making recommendations are confusing and hard to implement, and can ultimately create an access barrier for vaccination.
Women who get vaccinated during pregnancy can pass on protective antibodies to their babies, as we have reported and as a CDC webpage on the issue still said, as of June 4. Maternal vaccination during pregnancy is associated with a reduced risk of infection and hospitalization from COVID-19 during the first six months of a baby’s life, and particularly during the newborn period, according to multiple studies.
“[G]rowing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than six months of age—those who are not yet eligible for vaccination—born to unvaccinated mothers,” Dr. Steven J. Fleischman, president of the American College of Obstetricians and Gynecologists, said in a statement following Kennedy’s announcement.
Evidence shows that vaccination also protects the pregnant person from severe COVID-19.
“Removing pregnant women from the vaccine schedule is neither common sense nor good science,” Dr. Robert T. Schooley, a distinguished professor of medicine at the University of California, San Diego and former VRBPAC member, told us, referencing Bhattacharya’s comments in the announcement video. “This is an example of decision-making that is wrong on both process and outcome.”
In an interview on CBS’ “Face the Nation” on June 1, Makary misleadingly claimed, as he did previously in an interview with NBC News, that the data on the COVID-19 vaccine during pregnancy is “mixed.”
“Those 67 studies are mixed. The data in pregnant women is different for healthy versus women with a – a co-morbid condition. So, it’s a very mixed bag,” he said, when presented with a 2024 systematic review and meta-analysis of 67 studies evaluating the safety and effectiveness of COVID-19 vaccines during pregnancy. “So, we’re saying, your obstetrician, your primary care doctor and the pregnant woman should together decide whether or not to get it.”
Victoria Male, a senior lecturer in reproductive immunology at Imperial College London, told us that studies have included pregnant people regardless of underlying health conditions, so in that sense they are “mixed.” But the results themselves have not been mixed.
“It is unequivocal that COVID vaccination during pregnancy does not increase the risk of any problems during the pregnancy or with the baby, and is effective at preventing severe disease, which can cause problems,” she said.
It’s also misleading for Makary to have presented the policy change for pregnant people as simply one of discussing the option with a doctor, since by removing the CDC’s recommendation, insurance companies are no longer required to cover the vaccine.
“ACOG is concerned that as a result of the new CDC recommendations, payers may be less likely to cover the COVID-19 vaccines, leaving patients to pay out of pocket or unable to get vaccinated at all,” an ACOG spokesperson told us in an email.
What do experts think of the FDA’s new framework?
Many experts are skeptical of the framework’s call for new randomized, placebo-controlled trials before approving COVID-19 vaccines for healthy people below the age of 65.
In the NEJM commentary, Makary and Prasad said that the FDA considers the healthy 50- to 64-year-old population an “ideal population for future trials,” but that vaccine companies can also choose to conduct trials for other younger, healthy groups. They noted that very young children — those below the age of 4 — are at higher risk of severe COVID-19 than older children, but the risks “remain lower than those for adults 65 years or older and on par with those for adults 50 to 64 years old.”
The two officials indicated that the FDA would want the trials to demonstrate a significant reduction in the risk of symptomatic infection — 95% confidence that the vaccine’s efficacy is above 30% — with follow-up of at least six months, in a population that includes participants who have had COVID-19 in the past year. The trials should also assess outcomes of severe COVID-19, hospitalization and death, they said.
It’s not clear whether vaccine makers will want to conduct those trials, as they are likely to take time and be very expensive. Makary said in a Senate hearing on May 22 that he anticipated the trials would take “roughly a year” to complete. As staffers and advisers with the Vaccine Integrity Project, an initiative with the University of Minnesota’s Center for Infectious Disease Research and Policy, wrote in a viewpoint article, it is unclear how that timeline fits with a vaccine that would need to be rolled out within the same season to target the primary variants in circulation.
Experts have also noted that conducting placebo-controlled trials is ethically questionable, given that there is now a vaccine available. Typically, investigators can only ethically conduct a trial when there is genuine uncertainty over whether a vaccine is beneficial. Otherwise, a trial would be denying a protective vaccine from one group. And ultimately, experts question the benefit of doing new trials, when an abundance of safety and effectiveness data already exists.
In their video, Prasad and Makary pointed to former FDA Commissioner Dr. Robert Califf, who served under Presidents Barack Obama and Joe Biden, endorsing the idea of performing such trials.
“In the case of COVID-19 I believe it would now be quite reasonable, and even advisable, to conduct placebo-controlled trials for ‘boosters’ using updated versions of the vaccine in people who are not high-risk,” Califf wrote in a May 9 Substack post, echoing a viewpoint he published in the Journal of the American Medical Association.
Other experts, however, disagree.
“I can’t imagine an institutional review board would approve that kind of study,” Dr. Paul Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia who’s a current member of VRBPAC and a former member of ACIP, told us in an interview, citing consistent CDC data that annual updated shots provide a benefit, regardless of age or risk factors, even in the background of high immunity. “I think it’s a wholly unethical prospect.”
In the May 22 VRBPAC meeting, Dr. Eric J. Rubin, an adjunct professor of immunology and infectious diseases at Harvard T.H. Chan School of Public Health and editor-in-chief of the NEJM, also questioned the proposal, noting that the CDC had just presented a lot of “very reassuring” effectiveness data on the vaccine, which could mean there is not enough uncertainty to ethically conduct such trials.
Even though he’s “a believer” when it comes to randomized controlled trials, Rubin said, “observational data has a lot more richness in the case of a very varied population with all kinds of different exposures. So I think this is a case where we learn a lot more out of observational data than we would out of an RCT and I don’t think the RCT is feasible.”
In the CBS interview, Makary also insisted that pregnant people could not rely on observational data and need a randomized controlled trial before continuing to receive COVID-19 vaccines. “A randomized controlled trial was set up and it was closed without any explanation,” he said.
Male, however, said that for that trial, there was “so much epidemiological data showing that COVID vaccination in pregnancy is safe and effective, that it was unethical to continue recruiting to the unvaccinated group.” She also noted that there is some data on the COVID-19 vaccines during pregnancy from the original trials, as 102 people in the Pfizer and Moderna trials became pregnant unintentionally. There was no increased risk of pregnancy problems in those who received the vaccines, she said.
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