As autumn approaches, the federal government’s latest guidance on COVID-19 vaccines has left many Americans uncertain about who exactly will be eligible for shots. Health and Human Services Secretary Jonathan Marks has said vaccines will be “available to all patients in consultation with their doctors,” but pediatric and medical groups warn that the fine print tells a different story. The changes could affect access for a wide range of people, including new mothers and otherwise healthy children.
“For many of the children and young adults I see, the constraints are real—and significant,” said Dr. Melissa O’Shea, a pediatrician in Michigan and spokesperson for the American Academy of Pediatrics (AAP).
Insurance coverage is also in limbo. A national vaccine advisory panel isn’t scheduled to meet until mid-September, which means it could be weeks before families know whether insurance will cover the shots at no cost.
Shifting Regulatory Ground
Last week, the Food and Drug Administration removed the emergency use authorization from all COVID-19 vaccines heading to the market this fall. While the vaccines remain FDA-approved, the move changes who manufacturers are allowed to target. For instance, Pfizer will no longer provide vaccines for very young children, which limits parental choice and could strain supply.
Here’s what the three major vaccine makers are currently cleared to offer:
- Moderna, Pfizer, Novavax: Shots for anyone 65+ regardless of health history.
- Pfizer: Shots for ages 5–64 with at least one underlying condition.
- Moderna: Shots for ages 6 months–64 with at least one underlying condition.
- Novavax: Shots for ages 12–64 with at least one underlying condition.
The Advisory Committee on Immunization Practices (ACIP), which has historically guided insurance coverage decisions, will weigh in later this month. Their recommendations often determine whether a vaccine is free at the pharmacy counter.
The Federal Response
Despite the uncertainty, federal officials insist the shots are still broadly available. In a post on X, Secretary Marks wrote: “These vaccines remain available for anyone, in consultation with their healthcare provider.”
Dr. Martin Calver, FDA commissioner, echoed that reassurance: “Every adult in the U.S. can still get the vaccine if they choose. We are not restricting availability.”
Yet on the ground, providers and families face practical challenges. Whether a doctor will prescribe the vaccine, a pharmacy can administer it, or insurance will pick up the tab is less clear.
Implications for Pregnant and Postpartum People
Pregnancy remains on the CDC’s list of conditions that put individuals at higher risk for severe COVID-19 outcomes, so pregnant patients are still expected to have access to vaccination.
But the situation is more complicated for new parents. According to the American College of Obstetricians and Gynecologists (ACOG), lactating and postpartum individuals must also have an underlying condition to qualify.
Dr. Steven Fletcher, president of ACOG, expressed concern: “Only lactating and postpartum patients with an underlying condition are eligible. Yet vaccination during pregnancy is critical, not only for the mother’s protection but for providing passive immunity to infants in those early months.”
What About Healthy Kids?
For children, the picture is murkier still. While parents may still be able to request vaccines for their healthy kids under a “shared clinical decision-making” model, that often means doctors would be prescribing the shot “off-label.”
Off-label use is legal but carries risks for providers, including liability concerns and potential insurance denials.
“Many pediatricians and pharmacies will hesitate to take that risk,” O’Shea noted.
Dr. Daniel Hewlett, medical director at the Westchester County Health Department, said costs could also fall on families: “Parents may be told, ‘Yes, we’ll vaccinate your child, but it’ll cost $200.’ That creates an obvious barrier.”
Some states restrict pharmacists to administering only FDA-approved uses, which could further complicate access. National chains such as CVS and Walgreens have already begun limiting shots in certain states to patients with prescriptions.
The supply question is another worry. With Pfizer narrowing its eligibility criteria, experts anticipate fewer doses overall for children, making it harder for families to find appointments.
Growing Concern Among Experts
The AAP has called the new guidance “deeply troubling,” warning that barriers to vaccination could leave children vulnerable as respiratory virus season ramps up.
Dr. Susan Kressly, president of the AAP, said: “Any parent who wants their child vaccinated should have access. Instead, families now face confusion, delays, and extra costs at a time when clear guidance is most needed.”
Charlotte Mason, co-director of the Vaccine Education Center at Children’s Hospital of Philadelphia, added that the changes undermine years of consensus-driven policymaking: “Decisions used to involve hundreds of clinicians and scientists. Now, with a small group steering the process, we’re losing that breadth of expertise.”
What Comes Next?
ACIP is set to meet September 18–19 to finalize recommendations. But even that gathering has drawn scrutiny. Senator William Cassidy, who chairs the Senate Health Committee, has questioned whether the restructured panel has the legitimacy to make binding decisions.
Until then, families are left navigating a confusing patchwork. Doctors must weigh liability, pharmacies face state-level restrictions, and insurers haven’t yet committed to covering the cost.
For parents and patients, the bottom line is frustratingly simple: while federal officials say the vaccines are available to all, the reality of access may depend on your doctor’s stance, your state’s rules, and your ability to pay.