Confusion and Barriers Increase as FDA Narrows Covid-19 Vaccine Approval for Healthy Americans

While federal officials say vaccines remain accessible, experts warn the new restrictions create hidden obstacles for millions of adults and children

Natalie C. Frank, Ph.D August 29, 2025

Adaptive Review Response [CC BY 4.0]

WASHINGTON, D.C. - The U.S. Food and Drug Administration recently narrowed the approval for Covid-19 vaccines, causing debate over what “availability” actually means for healthy Americans. While federal officials assert that everyone still has access to the shots, medical and public health experts warn that the limited approval may create practical barriers for many who want to protect themselves against Covid-19 this fall and winter.

On Wednesday, the FDA authorized updated Covid-19 vaccines primarily for seniors and younger individuals with underlying health conditions that increase their risk for severe illness. This marks a significant shift from prior approvals, which allowed everyone six months and older to receive the vaccine without restriction.

In a Thursday post on social media, FDA Commissioner Dr. Marty Makary emphasized that “100% of adults in this country can still get the vaccine if they choose. We are not limiting availability to anyone.” White House press secretary Karoline Leavitt echoed this sentiment, stating, “The FDA decision does not affect the availability of Covid vaccines for Americans who want them. We believe in individual choice.”

Yet for healthy adults under 65 and children without pre-existing conditions, receiving an updated Covid-19 vaccine now requires obtaining it “off-label.” This process entails getting a prescription from a healthcare provider, a step that complicates what was previously a straightforward trip to a pharmacy or drugstore.

“Technical availability and practical accessibility are very different things,” said Dr. Jake Scott, an infectious disease specialist at Stanford Health. “The administration replaced straightforward pharmacy access with a system requiring provider consultations, navigating insurance uncertainty and finding willing pharmacies.”

Historically, the majority of Covid-19 vaccinations have been administered at pharmacies or retail drug stores. Off-label prescriptions, however, demand interaction with a physician or qualified healthcare professional — and not all providers are equally comfortable prescribing in this context.

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“In the current environment, where things are turbulent, a bit strict and very uncertain, pharmacies might not want to put their businesses at risk of being accused of giving vaccines inappropriately,” noted Dr. William Schaffner, an infectious disease expert at Vanderbilt University.

Former U.S. Surgeon General Dr. Jerome Adams also raised concerns on social media. Highlighting that roughly 11% of adults in the U.S. are uninsured, he noted that “RFK promised – under oath – that anyone who wants a vaccine will be able to get one. Now he says you can only get one if your doctor says so. To be frank and objective, unless he’s also giving everyone access to free healthcare, he seems to be reneging on his promise. Math doesn’t add up.”

Insurance coverage for off-label vaccine prescriptions is inconsistent, potentially leaving patients with substantial out-of-pocket costs for a product that was largely free during previous campaigns. Dr. Kelly Moore, president and CEO of immunize.org, highlighted the inequity: “The idea of having people receive the vaccine prescribed off-label by a physician will work occasionally for some persistent people who have access to money to pay and a cooperative physician, but it is no solution for most of us.”

Dr. Scott emphasized that the notion of universal vaccine access is misleading. Children under five without high-risk conditions are no longer eligible for Pfizer’s Comirnaty vaccine following the rescission of emergency use authorizations, while Moderna’s Spikevax is limited to those with underlying conditions. These restrictions leave many parents seeking options for younger children facing a confusing patchwork of availability and recommendations.

Access may also hinge on decisions by the CDC’s Advisory Committee on Immunization Practices (ACIP), whose guidance can influence which vaccines pharmacists are authorized to administer in each state. In certain states, pharmacists cannot provide vaccines not explicitly recommended by the ACIP. CVS, for example, indicated it could offer shots in most states, but in 16 states plus Washington, D.C., it may face regulatory restrictions. Even when prescriptions are provided, navigating these rules could require additional appointments and approvals.

“The confusion will be at the point of service,” explained Dr. Georges Benjamin, executive director of the American Public Health Association. “There are some pharmacists and nurse practitioners that, if it’s not on the [CDC vaccine] schedule, by law, they’re not allowed to give it. Then there are physicians who may not keep it in their office for cost reasons. They’ll write a prescription, send you to the pharmacist to get it. But can the pharmacist then give it? That’s the question.”

State boards of pharmacy may need to clarify rules, which could result in 50 different systems of access across the country. Some of these changes might require legislative approval, potentially delaying uniform availability until early next year.

Amid these logistical hurdles, Covid-19 experts are unanimous on one point: the virus itself remains a serious threat. “Covid is not going away. We anticipate with full confidence, I’m afraid, that there will be a substantial winter increase in Covid and that we will have, as a consequence, hospitalizations, people admitted to intensive care units and some deaths. There’s no doubt about it,” Dr. Schaffner said.