As has been the case each year since 2022, updated COVID-19 vaccines were released leading into the fall season, and the shots should be broadly available to people age 6 months and up. For the first time, however, the vaccines are not approved for all age groups, and the vaccines are recommended by the Centers for Disease Control and Prevention only after a discussion with a health care provider.
Experts emphasize that there has been no real change in the benefits or risks of the vaccines, which are quite safe and offer additional protection against the coronavirus. Vaccination can benefit everyone but is particularly important for those at higher risk of severe illness, including older people, very young children, pregnant people and those with certain other risk factors.
In the end, the CDC recommendation means that most people who want a vaccine — even if they do not meet the approval criteria — can get one, although doing so may be more difficult.
Here, we explain what’s different this year and walk through the complexities of getting vaccinated under the new rules.
- What happened this year that’s different from the past?
- What do experts say about who should get the vaccines?
- What shots are available this year?
- Who is eligible to get a vaccine this year?
- Are some people eligible for additional doses?
- Are the shots still free, and where can I get one?
- Will there be new barriers to getting these vaccines?
What happened this year that’s different from the past?
In previous years, the Food and Drug Administration either approved or authorized COVID-19 vaccines for all ages 6 months and older, and the CDC also recommended the vaccines for all, while noting that vaccination is most important for higher-risk groups.
This August, the FDA approved the COVID-19 vaccines, but only for those age 65 and older or for those with a risk factor. At some point for each vaccine, according to FDA memos, the head of the vaccines division, an administration official, had overruled career staff that had recommended approval for a broader population.
The CDC’s Advisory Committee on Immunization Practices voted on Sept. 19 to recommend COVID-19 vaccination for everyone 6 months of age and up, but only after consultation with a health care provider, or what’s known as shared clinical decision-making.
The panel originally had been scheduled to vote on the COVID-19 vaccine recommendations in June. But that month, Health and Human Services Secretary Robert F. Kennedy Jr. dismissed the committee and installed new members of his choice. The CDC director, who had just been confirmed by the Senate, was fired in August, and other top officials resigned. Meanwhile, Kennedy has repeatedly made false or misleading claims about COVID-19 vaccines this year.
At its September meeting, ACIP did not complete its normal procedure of gathering and presenting the evidence behind its recommendations. Members made misleading and unfounded claims about vaccine safety, despite a lack of data showing new safety concerns. The CDC then did not announce that it had accepted ACIP’s recommendations until Oct. 6.
It’s worth noting that before Kennedy dismissed the prior advisory panel, the group was considering making age- and risk-based recommendations, given evidence that hospitalization rates in healthy older children and younger adults had declined from the early phase of the pandemic.
However, these recommendations would likely have been quite different from those the CDC ultimately made. Guidance that was being considered more decisively recommended the shots to very young children, older adults and other people at high risk of severe disease, rather than only recommending the shots after consultation with a health care provider.
Amid growing doubts about the vaccine guidance coming from the CDC, states and expert organizations have issued their own updated COVID-19 vaccine recommendations — some that are different from the agency’s for the first time in decades.
What do experts say about who should get the vaccines?
There is broad agreement among experts that vaccination is most important for people age 65 and older, those who are pregnant, babies and toddlers from 6 through 23 months, and people with health conditions that put them at high risk of severe COVID-19.
This advice is backed by clear patterns in the recent data on hospitalization rates for COVID-19, Dr. Fiona Havers, an infectious disease physician and respiratory virus and vaccine policy expert, told us. Havers formerly led the CDC’s Respiratory Virus Hospitalization Surveillance Network team before resigning in June, citing the corruption of CDC processes under Kennedy.
People age 75 and older have the highest rate of hospitalization, Havers said, and those age 65 to 74 have “very high rates” of hospitalization. “At the other extreme, very young children, particularly children under 2, and especially those babies less than 6 months of age, have high hospitalization rates for COVID,” she said. Outside these extremes of age, she said, those still at highest risk for severe COVID-19 are those with underlying medical conditions.
The COVID-19 vaccines were originally demonstrated to be effective at preventing symptomatic disease in randomized controlled trials. The CDC and others have monitored vaccine effectiveness since then, finding consistently that additional doses add protection, on top of the immunity people already have from past vaccination and infection.
The 2024-2025 vaccines reduced the risk of hospitalization and critical illness in adults age 65 and older, data presented at the September ACIP meeting showed, with the best and most lasting protection against critical illness. For children and adults more generally, the additional vaccine doses also lowered the rate of urgent care and emergency room visits.
Havers explained that vaccination during pregnancy is also “really important,” not only because pregnancy puts a person at risk of complications from COVID-19, but also because vaccination during pregnancy protects the baby. Babies under 6 months of age cannot yet be vaccinated against COVID-19. “The best way to protect them is for the moms to be vaccinated during pregnancy,” she said.
The latest guidance from the American College of Obstetricians and Gynecologists states that it “continues to recommend that all pregnant and lactating individuals receive an updated COVID-19 vaccine or ‘booster.’”
Guidance issued in August by the American Academy of Pediatrics recommends vaccination for all children from 6 through 23 months and older children who fall into various high-risk groups or whose household members are at high risk. The guidance states that older kids without risk factors can get vaccinated if a “parent or guardian desires their protection from COVID-19.”
The American Academy of Family Physicians, meanwhile, issued recommendations for children and pregnant people that match the AAP and ACOG recommendations. AAFP also recommends COVID-19 vaccination for all adults, with an emphasis on its importance for people with high-risk conditions, those who have never gotten a COVID-19 vaccine, and people age 65 and older.
Dr. Margot Savoy, chief medical officer for the American Academy of Family Physicians, told Spotlight PA that it broadly recommended vaccination in adults because there are few who don’t either fall into a high-risk group or live with someone who does. “So why make it more complicated than it needs to be?”
New recommendations from states or coalitions of states often draw on guidance from these expert organizations. State recommendations vary in their details, such as how broadly they recommend the vaccines for younger adults, but generally emphasize the importance of vaccination for the high-risk groups described above. As of a Sept. 24 review by the health policy research group KFF, 22 states “specifically identify non-federal entities as sources for their vaccine recommendations, either in addition to or instead of CDC/ACIP.”
But even if a person is not at high risk for severe disease or hospitalization, Havers explained, getting a vaccine can offer benefits. “You are likely to have milder disease if you are recently vaccinated and then you get COVID than if you hadn’t been vaccinated,” she said.
If older children have been previously vaccinated and are not in a high-risk group, the choice to vaccinate “could be considered ‘low risk, low reward,’” an informational page on COVID-19 vaccinations from the Children’s Hospital of Philadelphia states.
Havers said that “the best protection is going to be within the first couple of months after getting a vaccine.” Given that there has historically been a winter wave of COVID-19, “now is not a bad time to get” a vaccine, she said.
What shots are available this year?
There are four 2025-2026 formula COVID-19 vaccines: Spikevax and mNEXSPIKE from Moderna, Comirnaty from Pfizer/BioNTech, and Nuvaxovid from Novavax.
This year’s Comirnaty and Spikevax vaccines are updated versions of the two original COVID-19 mRNA vaccines. These vaccines use mRNA to prompt a person’s cells to temporarily make a small quantity of spike protein, the protein the coronavirus uses to get into cells. This prepares the immune system to respond when it encounters the virus.
It is relatively simple to update mRNA vaccines to target a slightly different version of the spike protein, since it only requires tweaking the sequence of the mRNA. This year, the mRNA vaccines target the spike protein from the LP.8.1 subvariant of the coronavirus.
LP.8.1 was the dominant subvariant when the FDA issued advice in May on formulations for the updated vaccines. It is part of the JN.1 lineage, which is itself part of the lineage of omicron variants that have been spreading since late 2021. CDC modeling indicates that as of late September, the most commonly circulating subvariant is the closely related XFG, which is a combination of an LP.8.1 subvariant and another JN.1 subvariant.
Unlike last year, there is a third, lower-dose mRNA vaccine, mNEXSPIKE, which was first approved on May 30 following testing in a randomized controlled trial comparing it to Spikevax. The study found the vaccines had similar safety and efficacy, with possibly improved efficacy for the newer vaccine in older adults with underlying conditions. By instructing the body to make just the two most critical parts of the spike protein, the mNEXSPIKE vaccine is able to use one-fifth the amount of mRNA included in the adolescent and adult dose of Spikevax.
Nuvaxovid targets the JN.1 variant, as it did last year. This vaccine contains the spike protein, rather than the mRNA instructions for making it. It takes longer to update protein-based vaccines than to update mRNA vaccines.
Who is eligible to get a vaccine this year?
Everyone age 6 months and older is eligible to get a COVID-19 vaccine under shared clinical decision-making, according to the CDC. Unusually, this recommendation is broader than the current FDA approval, which says the vaccines are only indicated for certain groups. But people should be able to get vaccines outside the FDA label after talking to a health care provider.
In the past, the CDC has issued shared clinical decision-making recommendations when it does not consider a vaccine to be universally necessary across a certain age or risk group, according to a page on the CDC website. Rather, a health care provider and patient should make the decision for or against vaccination, based on factors including individual health conditions and preferences, as well as health care provider discretion. Health care providers can be “anyone who provides or administers vaccines,” according to the CDC, including doctors, nurses, physician assistants and pharmacists.
In practice, recommending the vaccines under shared clinical decision-making “largely affirms that people considering vaccination should have an opportunity to discuss any questions about the vaccine with a health care provider before making their final decision, something that is already the norm for any vaccination,” Jason Schwartz, a professor at the Yale School of Public Health with expertise in vaccine policy, told us via email.
The ACIP recommendations emphasized that for people under age 65, the balance of benefits and risks is most favorable for those who have high-risk underlying conditions, as listed by the CDC.
Notably, the list of high-risk conditions includes pregnancy or recent pregnancy. That marks a shift from May when Kennedy announced that the CDC was no longer recommending COVID-19 vaccines for healthy pregnant women.
Until recently, children under age 5 could get either the Moderna or Pfizer/BioNTech vaccines, which were provided for this age group under emergency use authorizations.
But this summer, the FDA revoked the emergency use authorizations for these vaccines while also issuing the new, narrower approvals. Spikevax, from Moderna, is the only vaccine approved this year for those age 6 months and up. Comirnaty, the Pfizer/BioNTech vaccine, is approved for those age 5 and up. The Novavax vaccine and mNEXSPIKE are approved for age 12 and up.
Are some people eligible for additional doses?
The updated CDC vaccine schedule states that adults age 65 and older may get two or more doses of this year’s COVID-19 vaccines under shared clinical decision-making. It also states that for people who are moderately to severely immunocompromised, “Additional doses may be necessary,” also under shared clinical decision-making.
The vaccine schedule is not clear about when or how often people should get these extra doses, and ACIP has so far not weighed in on whether these additional doses are recommended.
Last year, ACIP and the CDC recommended in October that both older adults and people who are moderately to severely immunocompromised get a second dose of that year’s vaccine, at least two months but preferably six months after their prior dose. The guidance at the time added that people in the immunocompromised group could get additional doses beyond that after engaging in shared clinical decision-making.
“Typically, ACIP would have discussed and voted on the use of the vaccine in a more granular fashion than they did at their September meeting,” Schwartz said. “This would have included discussions of the use of the vaccines in particular populations, including groups for whom different dosing regimens would be appropriate.” However, he added, the vaccine schedule links to a non-updated clinical considerations document that lays out these details.
An HHS spokesperson did not reply to a request for clarification about the number of doses recommended for these high-risk groups.
Update, Oct. 22: The Infectious Diseases Society of America issued vaccination guidelines on Oct. 17 for immunocompromised patients, recommending at least one dose of a 2025-2026 COVID-19 vaccine for all such individuals 6 months and older. The guidelines stated that a second dose “is likely to extend protection” and that decisions on additional doses should be “based on prior vaccination history and clinical judgment.”
Are the shots still free, and where can I get one?
Any child 6 months of age and older and any insured adult should be able to get a COVID-19 vaccine without paying out of pocket, if the patient and a health care provider determine via shared clinical decision-making that vaccination is warranted.
“If that determination is made, insurers should cover the vaccine at no-cost, although it is possible that some consumers may face challenges,” a KFF analysis states. The vaccines are available at pharmacies or doctors’ offices, although availability will vary depending on whether providers choose to stock the vaccines.
Vaccines recommended by ACIP and the CDC are required to be offered at no cost to most people with private insurance, Medicare or Medicaid. The Vaccines for Children program, for which half of all U.S. children are eligible, offers free recommended vaccines to children who are uninsured or underinsured, eligible for Medicaid, or American Indian or Alaska Native. A smaller number of children get free recommended vaccines via the Children’s Health Insurance Program, which offers low- or no-cost coverage for kids who don’t qualify for Medicaid.
The CDC said in its Oct. 6 press release that recommendations based on “individual-based-decision-making,” also known as shared clinical decision-making, “allows for immunization coverage through all payment mechanisms,” including those mentioned above.
Will there be new barriers to getting these vaccines?
Some experts are concerned that in practice, this year’s federal approach to COVID-19 vaccine approvals and recommendations could open new gaps in access.
Havers said that health care providers tend to dislike such broad recommendations for shared clinical decision-making “because it gives them no guidance and nothing clear to follow.”
She said she was particularly concerned about very young children falling through the cracks. “The under 2 group has never had COVID before, and they have an underdeveloped immune system, and they’re at high risk for severe disease if they get COVID,” she said. Nothing, however, in the CDC’s recommendations indicates that these young kids are at particularly high risk. Moderna’s Spikevax is the only vaccine FDA-approved for this age group, and the approval is only for children with underlying conditions.
Even if vaccines should be theoretically available to young children, getting a child vaccinated requires finding a provider who has pediatric doses in stock and is able to vaccinate. Pharmacies vary in the age groups for which they stock vaccines and face restrictions on vaccinating the smallest children.
Some pediatricians’ offices were waiting for the CDC sign-off to order doses, and some may choose not to order doses if demand is low. The Vaccines for Children Program also was unable to ship doses until the CDC signed off on the recommendations.
Confusion could also keep people from getting vaccinated.
Health care providers are allowed to give vaccines to people for whom they are not approved, a practice called off-label use. It’s not “unprecedented” for providers to give vaccines off-label, but Schwartz did call it “quite uncommon” in a blog post on the Yale website. “Here, ACIP has opened the door to off-label use of the vaccine for tens of millions of Americans, essentially all healthy individuals between 6 months and 65 years of age,” he said.
“There could be some providers (and individuals) who are confused about how the approval relates to the recommendation,” Jennifer Kates, senior vice president and director of the Global Health & HIV Policy Program at KFF, told us via email. “This could create a barrier for someone seeking to get a COVID vaccine.”
Havers also said that historically, expert groups such as the American Academy of Pediatrics were included in discussions leading up to the issuance of CDC guidance and would endorse one unified recommendation. The variety of recommendations now being issued is “more confusing for patients and more confusing for providers,” she said.
Members of the Vaccine Integrity Project, an initiative of the University of Minnesota’s Center for Infectious Disease Research and Policy, also pointed to the lack of government advertising and media campaigns to encourage vaccination against COVID-19 and other diseases this year. “If you add the conspicuous absence of pro-vaccination messages to the glut of misleading statements from top health officials about vaccine safety and effectiveness, the federal government’s effort this year looks more like a proactive campaign to discourage vaccination,” the authors said in a Sept. 30 post (emphasis theirs).
“There’s confusion around what the federal government is recommending, and there’s increased vaccine skepticism writ large,” Kates told us in an interview. “That is likely going to dampen vaccine rates.”
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