Guidance around COVID-19 vaccines has once again shifted after the Food and Drug Administration on Aug. 27, 2025, approved updated shots for the fall season, but for a more limited group than in prior seasons.
These changes, announced on X by Secretary of Health and Human Services Robert F. Kennedy Jr., raise new questions about eligibility and availability of COVID-19 vaccines for children.
As a pediatrician and researcher who studies vaccine delivery and health policy, I foresee these changes adding to the confusion facing parents and providers, just as this summer’s COVID-19 wave continues to rise.
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How does the new guidance differ from before?
The FDA revoked the emergency use authorizations for COVID‑19 vaccines, a status used during public health emergencies that made it possible to provisionally approve vaccines swiftly during the pandemic. The agency also limited their approval to only people at higher risk of serious illness from COVID-19 infection, such as those over 65 or with underlying health conditions. But for children it is even more complicated.
The FDA approved two updated mRNA-based vaccines – Moderna’s vaccine for children 6 months and older and Pfizer’s vaccine – both targeting a new variant called LP.8.1, for children 5 years and older. The agency also approved an updated version of the the protein-based Novavax vaccine targeting a strain of the virus called JN.1 for children 12 years and older. But all three approvals are limited to children at higher risk of serious illness from COVID-19 infection.
Previously, all children 6 months and older were able to receive either the Pfizer and Moderna vaccines, with the Novavax vaccine available for anyone 12 years and older. These changes mean it may be significantly more difficult for infants and young children to get vaccinated, even though they remain at higher risk for complications from COVID-19 compared with the general population.
The decision comes as, for the first time in decades, guidance from federal health authorities and pediatric experts diverge. The Centers for Disease Control and Prevention no longer routinely recommends COVID-19 vaccines for healthy children ages 6 months to 17 years. The decision to take this approach bypassed the CDC’s normal independent review panel, creating concerns about credibility.
In contrast, the American Academy of Pediatrics recently issued its own guidance based on its review of the evidence. The AAP recommends that all children 6 months to 23 months old and children 2 to 18 years old at higher risk receive vaccines. They also emphasize that COVID-19 vaccines should be available for all children whose parents want them.
The AAP’s review of the evidence showed COVID-19 remains a serious risk for young children and kids with certain high-risk conditions. It also found that children are still being hospitalized and dying at rates similar to those with other illnesses for which vaccines are routinely recommended, such as influenza. And an independent expert group called the Vaccine Integrity Project confirmed that no new safety concerns have emerged relating to COVID-19 vaccines and that the vaccines remain effective.
How might access to COVID-19 vaccines for kids change?
Despite young children remaining particularly vulnerable, changes to FDA approval and conflicting recommendations will mean access to vaccines could be challenging.
Children under 5 years of age can now only receive Moderna’s vaccine. Providers who had planned to use Pfizer’s vaccine need to quickly pivot, and Moderna will need to fill supply gaps. Also, providers may not be able to use any Pfizer vaccine stock they still hold now that the emergency use authorizations is no longer in effect. Families who already face barriers to vaccination, such as those who live in rural areas or who lack health insurance, may be especially affected by these new limitations.
If providers give healthy children a COVID-19 vaccine, they would be doing this “off-label,” meaning different than what the FDA label says. This practice is legal and common, with an estimated 1 in 5 medications prescribed off-label. However, while physicians can give vaccines off-label, in many states, pharmacists and other non-physicians may not be able to do so for any age.
Even if it is legal, some providers may be hesitant to give COVID-19 vaccines off-label. After the AAP released its own recommendations, Kennedy warned that vaccine recommendations that diverge from the CDC’s official list are not protected from liability, though legal experts argue that this is misleading.
The AAP published a list of high-risk health conditions or characteristics to guide parents and providers in deciding whether a child should receive the vaccine.
At the federal level, the only current list is on the CDC website and is not specifically related to COVID-19 vaccine recommendations. For example, it includes pregnancy, even though federal health leaders have previously stated the vaccines would no longer be recommended in pregnancy. In contrast, the American College of Obstetricians and Gynecologists strongly recommends updated COVID-19 vaccination during pregnancy, when planning pregnancy, in the postpartum period and while lactating, noting benefits for both patients and their newborns.
What might happen next?
Unfortunately, the confusion may deepen as the CDC’s recommendations, including who is at high risk, may be revised after an upcoming meeting of the Advisory Committee on Immunization Practices, a panel of independent experts that advises the agency.
In June 2025, in an unprecedented move, Kennedy disbanded the entire committee and hand-picked new members. The new committee has yet to weigh in on COVID-19 vaccines for children. The chair of the COVID-19 vaccine work group, which will make recommendations to all committee members, is led by an outspoken critic of COVID-19 vaccines who does not have a biomedical degree or medical experience. Also, on Aug. 27, 2025, federal officials attempted to oust the CDC’s director just a few weeks after she was confirmed, and multiple top officials resigned.
The bottom line is that with these FDA changes, fewer vulnerable children may end up vaccinated against COVID-19 because of supply constraints, parental confusion or provider uncertainty. The best thing a family can do is talk with their pediatrician about what options remain and what is best for their child.
