On August 27, 2025, the US Food and Drug Administration (FDA) approved updated Covid-19 vaccines, but with a significant shift in policy: instead of blanket availability, the shots are now authorized primarily for adults 65 and older and for younger people who face a higher risk of severe illness from Covid-19. This move, which federal officials say is rooted in current scientific evidence, has sparked a heated debate among medical professionals, parents, and public health advocates about access, science, and the future of pandemic prevention in the United States.
The FDA’s new marketing authorization covers three vaccines: Moderna’s Spikevax (for those 6 months and older with qualifying risk factors), Pfizer’s Comirnaty (for ages 5 and up), and Novavax’s protein-based shot (for those 12 and older with underlying conditions, and all adults 65+). US Health and Human Services Secretary Robert F. Kennedy Jr. emphasized in a post on X, “FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors.”
But what does “higher risk” mean? According to the Centers for Disease Control and Prevention (CDC), the list is long: asthma, blood cancers, cerebrovascular diseases, chronic kidney or liver conditions, cystic fibrosis, both type 1 and type 2 diabetes, gestational diabetes, disabilities like Down syndrome, heart conditions, HIV, mood disorders, dementia, Parkinson’s disease, obesity, physical inactivity, pregnancy, immunodeficiencies, smoking, organ transplants, tuberculosis, and use of immunosuppressive drugs all qualify. That’s a wide net—FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, estimated in the New England Journal of Medicine that between 100 million and 200 million Americans fit under this new framework.
While the FDA and CDC maintain that those who want a vaccine can still access one after consulting with their doctor, the reality on the ground is more complicated. Emergency use authorizations for Covid-19 vaccines were rescinded as of August 27, 2025, which means Pfizer’s Comirnaty is no longer authorized for children under 5. Moderna’s Spikevax remains approved for children as young as 6 months, but only if they have an underlying health condition that puts them at greater risk. Novavax’s vaccine, the only protein-based, non-mRNA option in the US, is now available solely to people 65 and older and those 12 and up with at least one qualifying medical condition.
This policy shift comes at a time when Covid-19 activity is on the rise again. Wastewater surveillance and CDC data show that virus levels in late August 2025 are about half those seen at last summer’s peak, but they match the summer 2023 peak, with epidemiologists warning that there are “no signs of slowing yet.” In the first week of August, there were about 1.7 Covid-19 hospitalizations per 100,000 people, with the highest rates among seniors and children under 5. In fact, during the last respiratory virus season, there were 48 Covid-19 hospitalizations for every 100,000 children under 5—nearly seven times the rate for older children and more than double the rate for adults under 50.
Not surprisingly, the new eligibility criteria have drawn sharp criticism from pediatricians and public health advocates. Fatima Khan, co-founder of Protect Their Future, told CNN, “Our health care system is now solidly anti-children and anti-science. The data are clear: young children—especially infants—remain highly vulnerable to severe illness and hospitalization from Covid-19. By restricting access to safe, evidence-based vaccines, federal leaders are choosing ideology over science.” She added, “Denying children a critical tool to prevent avoidable tragedies will be a lasting stain on every policymaker who allowed it to happen.”
Professional organizations have also weighed in. Dr. Susan Kressly, president of the American Academy of Pediatrics (AAP), said, “Any parent who wants their child vaccinated should have access to this vaccine; today’s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children. Parents and pediatricians, together, make the best decisions to protect children’s long-term health.” The AAP has broken with the CDC by recommending Covid-19 shots for all infants and young children, regardless of risk factors, unless they have a known allergy to the vaccine or its ingredients. The American College of Obstetricians and Gynecologists has also reaffirmed its support for Covid-19 vaccination during pregnancy, even as the CDC has declined to recommend the shots for pregnant women.
On the other side of the debate, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad argue that more evidence is needed. In May, they stated, “There’s not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots,” calling for more placebo-controlled trials, especially for adults aged 50 to 64, before expanding recommendations to those groups. The FDA insists that its decision “does not affect access to these vaccines. These vaccines remain available to those who choose them in consultation with their healthcare provider.” Dr. Tina Tan, president of the Infectious Diseases Society of America, noted that vaccines may be accessible to healthy younger people “off-label,” but warned, “The new FDA decision completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID.”
For many Americans, access will depend on where they live and what insurance they have. Pharmacies like CVS and Walgreens are preparing to offer the updated vaccines as soon as they arrive, but state regulations complicate matters. As of late August, CVS was not offering Covid-19 vaccinations in 16 states and Washington, DC, due to local laws. In some states, pharmacists can only administer the shots if prescribed by an authorized provider. Walgreens echoed that it will offer the vaccine where permitted by state regulations. Most Covid-19 vaccinations in the US have been administered at pharmacies, with CDC data showing that 71.5% of shots during the 2023-24 season were given in drug stores.
Insurance coverage is also a patchwork. Those on Medicare and Medicaid who meet eligibility criteria will likely continue to have their vaccines covered. Private insurance coverage, however, may vary, especially for conditions that are loosely defined—like physical inactivity or certain mental health disorders. Under the Affordable Care Act, vaccines recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP) must be covered, but the current divergence between ACIP and CDC recommendations could create gray areas.
For those who don’t meet the new eligibility criteria, there’s still a possibility of getting vaccinated. Dr. Makary stated, “100% of adults in this country can still get the vaccine if they choose. We are not limiting availability to anyone.” Healthcare providers can administer the vaccine “off-label,” though pharmacists’ ability to do so is often more restricted, making the role of physicians and clinicians even more crucial in maintaining access.
Looking ahead, vaccine makers are working on combination shots that could target both Covid-19 and influenza in a single dose. Moderna has already released data on an experimental flu+Covid vaccine for adults 50 and older, and Pfizer/BioNTech are conducting clinical trials for their own combination product. Novavax is seeking a partner to continue developing its own version.
As the US enters another fall with rising Covid-19 cases, the debate over who should get vaccinated—and how easily they can do so—remains as contentious and consequential as ever. The choices made by federal agencies, state governments, insurers, and individual providers will shape not just this season’s response, but the nation’s approach to pandemic preparedness for years to come.
