The Fall Trip To The Pharmacy For A Covid Shot May Be Strewn With Obstacles

The millions of Americans who are used to getting their Covid-19 vaccines at a local pharmacy may face new hurdles this fall depending on where they live and whether federal health officials have decided they qualify.

Pharmacists’ authority to vaccinate individuals varies across state lines. In some places, it’s dependent upon a federal advisory process that Health Secretary Robert F. Kennedy Jr. has upended.

At the same time, the Food and Drug Administration has signaled that it will only approve updated Covid vaccines for individuals 65 and older and for younger people considered to be at high risk for severe disease. People, regardless of where they live, may need to prove that they need the shot.

The agency is expected to sign off on the new vaccine formulas and labels any day now. The action will halt administration of the current vaccines, which are approved for most adults and children, regardless of underlying conditions.

“This usual chain of decisions … has been disrupted. And without clarity and coordination, millions may not be able to have clear access to Covid vaccines, and that could potentially impact hospitalizations and deaths,” said Katelyn Jetelina, an epidemiologist and public health communicator. “It’s as simple as that.”

Department of Health and Human Services spokesperson Andrew Nixon said in a statement that HHS “is committed to ensuring Americans continue to have access to safe and effective vaccines.”

“We will work closely with federal and state partners to minimize disruptions in vaccine access and protect the public’s health,” he added.

State obstacles

At least 18 states and Washington, D.C. tie their pharmacists’ vaccination authority to the official recommendations of the Centers for Disease Control and Prevention or its Advisory Committee on Immunization Practices, whose membership Kennedy overhauled in June to include several skeptics. The panel usually votes in June to recommend who should get the updated Covid shot in the fall, but months later there’s still not a firm date for the vote.

Without an official recommendation, pharmacists told POLITICO that residents of those jurisdictions may not be able to get vaccinated at neighborhood pharmacies, which have played the primary role in delivering the shots since early 2021. Nearly 90 percent of Covid vaccine doses during the 2024-2025 season nationally were given at pharmacies, according to CDC data.

“We’re very concerned that we’ll miss a bunch of patients and that it will impact vaccine coverage rates,” especially among older adults, who are more susceptible to hospitalization and death, said Brigid Groves, vice president of professional affairs at the American Pharmacists Association.

To restore accessibility, pharmacy groups are asking governors in the affected jurisdictions to sign executive orders to ensure pharmacists and pharmacy technicians may administer Covid vaccines, even if the CDC and its advisers haven’t officially recommended them. The states include Colorado, Connecticut, Georgia, Iowa, Maine, North Carolina, Pennsylvania, Virginia and West Virginia, among others.

“The normal processes that the profession has come to expect and where we usually get our marching orders from … that whole process has been disrupted with the new administration and the new HHS secretary,” said Hannah Fish, senior director of strategic initiatives at the National Community Pharmacists Association.

The ACIP was tentatively scheduled to hold a meeting in August or September, but the group has yet to formally announce a date. Its next regularly scheduled meeting runs from Oct. 22 to Oct. 23 — several weeks into the fall virus season.

The under-65 hurdle 

If the FDA narrows eligibility, people between 6 months and 65 years old who want a Covid vaccine this fall likely will have to navigate some roadblocks.

They, or their parents, may need to convince pharmacies and doctors that they have at least one of the underlying conditions that the FDA has suggested makes them eligible for a dose. The list includes asthma, diabetes, cancer, mood disorders and obesity. It’s unclear at this point what would serve as adequate proof.

Healthy people who want to be vaccinated, perhaps because they live with someone who is immunocompromised, could seek an off-label prescription from a doctor. Pharmacists generally don’t write off-label prescriptions — in which a drug is prescribed to someone for a condition for which the FDA has not approved it — for liability reasons linked to scope of practice requirements that vary by state.

Both scenarios will require more planning by consumers than they’ve had to do since Covid vaccines became widely available five years ago. Those without the time or wherewithal may wind up skipping the shot, experts said.  

That hassle aside, many Americans already are, with fewer than 1 in 4 adults and about 1 in 8 children receiving the latest Covid vaccine, according to the CDC.

Jetelina said she thinks some doctors will be reluctant to prescribe Covid shots off-label, even though the practice is legal.

“There hasn’t ever been this big of a pool that could be eligible for” off-label prescribing, she told POLITICO. “The scale of it is unique.”

Dr. Jesse Hackell, an official with the American Academy of Pediatrics, said he thinks some providers “will have more concern” about giving Covid vaccines off-label because of their politicization.

But he noted that pediatricians often prescribe drugs for uses beyond their labels since most drugs are developed for adults or adolescents before they are approved for younger children. For example, doctors sometimes administer the measles, mumps and rubella vaccine off-label to children between the ages of 6 months and just under 1 year who are living in outbreak regions or traveling abroad, Hackell said.

“It’s not new to us to think about things this way,” he said.

Further complicating vaccination efforts for children this year: the FDA may pull Covid vaccine-maker Pfizer’s emergency use authorization for its shots for children under 5. A spokesperson told POLITICO that the company has had discussions with the agency to maintain the authorization while it continues collecting data for a license application.

A spokesperson for Moderna, which has an FDA-approved Covid vaccine for children as young as 6 months, said the company is prepared to fill supply gaps if Pfizer’s product becomes unavailable.

Even ahead of the FDA’s anticipated narrowing of Covid vaccine eligibility, Americans have run into problems accessing the existing formulation that was recommended for anyone six months and older in 2024.

The American Academy of Pediatrics filed a motion Wednesday to add another anonymous plaintiff to its lawsuit challenging Covid recommendation changes that Kennedy announced in May for kids and pregnant women. The CDC later adopted the removal of the recommendation for pregnant women but allowed healthy children to still receive the current vaccine through shared decision-making between families and providers — a step below a routine recommendation.

The third Jane Doe, who is immunocompromised, said she took her two teenage sons to a Seattle-area pharmacy this month and explained why she wanted to have them get vaccinated. The pharmacist denied the request after saying the boys were ineligible due to their ages, according to the lawsuit.

Experts outside the CDC

Amid the confusion and barriers to accessibility, medical associations and other groups are putting forward their own vaccine recommendations for children, pregnant people and adults in light of Kennedy’s ACIP overhaul.

The American Academy of Pediatrics released its childhood schedule this week and highlighted its differences from the CDC’s version, and the American College of Obstetricians and Gynecologists has said it will issue its own advice for pregnant people by the end of the summer.

Pharmacy groups in turn are developing “guiding principles” that lawmakers in the jurisdictions relying on ACIP’s recommendations could use to broaden the pool of expert recommendations that pharmacists can rely upon to administer vaccines. The principles could include the use of any national organization with a clinical review committee, like the American Academy of Pediatrics or the Infectious Diseases Society of America, Groves said.

“The executive order would be the stopgap in the meantime,” she added.

Pharmacists will be available to advise customers about vaccine uptake this fall, Fish said, even if they have to encourage patients to make multiple trips to get Covid shots or send them to a doctor’s office for a prescription.

“We’re still a trusted resource to have questions answered,” she said.