Updated COVID-19 vaccines are set to roll out across the United States this fall, but new federal policies are reshaping who can actually get them—leaving many Americans confused, frustrated, and, in some cases, unprotected. The Food and Drug Administration (FDA) approved the new shots on August 27, 2025, but with a significant twist: eligibility is now tightly restricted. Only those aged 65 or older and individuals with at least one chronic health condition—such as asthma, cancer, obesity, or being immunocompromised—qualify for vaccination under the latest guidelines, according to both Healthline and The New York Times.
This marks a sharp departure from previous seasons, when COVID-19 vaccines were available to all Americans aged six months and older. Now, healthy adults under 65 and children without underlying health risks are, for the first time, largely excluded. The FDA’s decision, which federal health officials say is aimed at targeting those most at risk, has drawn criticism from many in the medical community and sparked concern among parents and caregivers.
“With fewer persons vaccinated, we can anticipate an increase in hospitalizations, intensive care unit admissions, and even deaths during the coming winter season,” warned Dr. William Schaffner, an infectious disease specialist at Vanderbilt University, in comments to Healthline. Pediatrician Dr. Danelle Fisher of Providence Saint John’s Health Center echoed those worries: “It’s a really scary proposition that vaccines might not be available to everyone. We may see what havoc COVID can still cause. Fasten your seat belts.”
So, who exactly can get the new shots? The FDA limits COVID-19 vaccinations to high-risk younger adults and children with at least one chronic health condition, such as obesity or asthma. Children under five will no longer have access to Pfizer’s COVID-19 vaccine, though they remain eligible for Moderna and Novavax shots. All U.S. adults 65 and older are still eligible, and the American College of Cardiology recommends the new vaccines for anyone with cardiovascular disease, as well as for those at risk from influenza and RSV.
The policy shift began earlier this year. In May, the Centers for Disease Control and Prevention (CDC) and the FDA stopped recommending COVID-19 vaccines for healthy adults under 65, pregnant people, and healthy children. Then, in August, Health and Human Services Secretary Robert F. Kennedy Jr. announced the elimination of $500 million in funding for 22 mRNA vaccine development programs—a move that has alarmed scientists and public health experts alike. Just a week later, Kennedy’s agency revived the Task Force on Safer Childhood Vaccines, raising further concerns about a potential turn toward anti-vaccination policies.
“This is a half-billion-dollar decision based on fundamentally flawed science,” said Dr. Jake Scott, an infectious disease specialist at Stanford University, to Healthline. “Most of the studies in there show harmful effects from COVID infection, which actually supports vaccination, not the opposite.” Dr. Scott also pointed out that mRNA vaccines can be updated much more quickly than traditional inoculations, a crucial advantage when facing new variants: “We’re abandoning the one vaccine technology that can be updated in weeks instead of months. When the next pandemic hits—and it will—those extra months of development time mean preventable deaths.”
Vaccine makers are moving quickly to get the updated shots out. Moderna and Pfizer have promised to ship almost immediately following FDA approval, while Novavax expects its vaccine to be available in early fall. The new formulas are designed to tackle the latest strains, including the fast-spreading "Stratus" Omicron subvariant that has fueled a late-summer surge in cases.
But getting a shot may not be straightforward for everyone. For those who don’t meet the FDA’s criteria, options are limited. Doctors can technically prescribe vaccines off-label, but some may hesitate due to concerns about liability, and insurance coverage for off-label use is far from guaranteed. Pharmacies—once the go-to for quick COVID-19 shots—are now hamstrung by state laws and CDC guidelines. In 18 states and Washington, D.C., pharmacists’ authority to vaccinate is tied directly to CDC recommendations. As a result, major chains like CVS are not offering COVID-19 shots in some states and the District of Columbia, while Walgreens is requiring prescriptions in several states, according to The New York Times.
What about proof of eligibility? That’s another gray area. Some pharmacies may simply ask patients to complete a form attesting to their high-risk status, while others might demand more rigorous documentation, such as a doctor’s note or prescription records. “If they feel that their license is at any risk, they’re not going to vaccinate,” said Spreeha Choudhury, a lawyer and former pharmacist, to The New York Times.
For those who do qualify, COVID-19 shots remain free with insurance. But if the CDC’s vaccine advisory panel narrows its recommendations further, some insurers could stop covering the shots even for older or high-risk patients. The CDC panel itself has come under scrutiny after Secretary Kennedy purged several members in June, replacing them with individuals known for anti-vaccine views—a move that has left the future of broad vaccine recommendations in doubt.
Medical organizations are not on board with the new restrictions. The American Academy of Pediatrics (AAP) recently broke with federal officials, urging parents to have all children ages six months to 18 years vaccinated against COVID-19. The AAP’s stance is particularly notable given that children under two—who are now largely excluded from eligibility—have some of the highest rates of severe illness from COVID, even if they are otherwise healthy.
Experts fear that these changes could undermine the nation’s already slipping vaccination rates. The CDC reports that coverage among U.S. kindergartners has dropped for all standard vaccines, with exemption rates rising and herd immunity weakening. “These aren’t isolated families—they’re concentrated communities where measles or whooping cough can tear through unprotected children. We’ve seen it happen before and we’re setting up for it to happen again,” said Dr. Steven Jensen, a pediatrician at Miller Children’s & Women’s Hospital in Long Beach, to Healthline.
For those who do contract COVID-19, symptoms usually resolve without medical intervention—rest, fluids, and over-the-counter medications are still the mainstays of care. For persistent symptoms, doctors may prescribe the antiviral therapy Paxlovid. To reduce the risk of infection, experts continue to recommend good sleep, nutrition, regular exercise, frequent handwashing, and mask use in crowded public spaces or during travel.
As the U.S. heads into another winter with COVID-19 still circulating, the landscape for vaccination is more fractured than ever. The new policies may have been designed with risk stratification in mind, but critics argue that they leave too many people—especially children and caregivers—exposed. “When vaccination rates drop, viruses don’t just affect the unvaccinated,” Dr. Scott told Healthline. “They spread through schools, overwhelm hospitals, and put vulnerable people at risk. We’re setting ourselves up for preventable outbreaks.”
With the latest COVID-19 vaccines on the horizon but access more limited than ever, Americans are left to navigate a maze of eligibility rules, insurance hurdles, and shifting recommendations—hoping that, this season, the virus doesn’t find the gaps left by policy.
