Shifting federal COVID-19 vaccine criteria are making seasonal vaccinations a more complicated process, both for patients and providers.
Retail pharmacies are often the most convenient places for patients to get COVID-19 vaccines, and, up until recently, it didn't require a prescription and insurance companies covered the shots. COVID vaccines had been available to anyone 6 months and older regardless of their health, based on recommendations from the Centers for Disease Control and Prevention (CDC).
Nearly 90% of people in the U.S. who received the COVID-19 shot in 2024 received it at a pharmacy, according to CDC data.
But that will be more difficult now.
The Food and Drug Administration (FDA) recently approved the next round of COVID-19 vaccines but only for a smaller, high-risk group. The administration is restricting their use for people ages 65 and older as well as adults and children over 6 months who have risk factors for developing severe COVID-19.
The FDA has approved Moderna's mRNA vaccine for those ages 6 months and older, the Pfizer-BioNTech mRNA vaccine for those ages 5 and older and the Novavax vaccine for those ages 12 and older.
Pharmacies and providers are now navigating a regulatory patchwork with slightly different vaccine policies across 49 states and Washington, D.C., as the industry awaits recommendations from the CDC's revamped Advisory Committee on Immunization Practices (ACIP). That advisory panel is scheduled to meet later this month.
In many states, pharmacists cannot administer vaccines that are not on the ACIP's recommended list, even if a vaccine has FDA authorization.
"Let’s be clear, @RobertKennedyJr is currently limiting access to vaccines by preventing pharmacists from doing their job. This is playing out as we speak," wrote Vin Gupta, M.D., public health physician and pulmonologist, posted on X.
CVS Health, the largest pharmacy chain in the U.S., has shifted its policies for administering COVID vaccines to patients.
In 13 states, including New York, Florida, Pennsylvania and Arizona, and in Washington, D.C., patients, regardless of age, will need a prescription from an authorized prescriber to get an updated COVID-19 shot from a CVS Health pharmacy or MinuteClinic, according to the company.
In three states—Massachusetts, New Mexico and Nevada—CVS pharmacies cannot administer the COVID vaccine without ACIP approval, even with a prescription.
Based on the current regulatory environment, CVS Pharmacy is offering FDA-authorized COVID-19 vaccinations in 34 states to consumers if they meet the newly restricted criteria (over the age of 65 or those with certain health conditions and/or risk factors). States may change at any time, the company said.
According to the CDC, health conditions that put an individual at high risk for severe illness from COVID include cancer, heart disease, lung conditions, overweight or obesity, depression and pregnancy, among many other conditions.
At CVS pharmacies, patients with these conditions will have to attest to being high-risk during the appointment scheduling process on the CVS Health app and CVS.com, or at the pharmacy or MinuteClinic when the patient is completing the health screening form, according to Amy Thibault, a spokesperson for CVS Health.
"We expect to receive the updated 2025-2026 COVID-19 vaccines in the coming days. We’ll administer FDA-authorized COVID-19 vaccines in states where legally permitted at CVS Pharmacy and/or MinuteClinic to meet our patients’ needs," Thibault told Fierce Healthcare.
Appointments can be scheduled online via CVS.com or through the CVS Health app, or patients can walk into CVS pharmacies and clinics, Thibault said.
A Walgreens spokesperson said with the recent FDA approval of the 2025–26 COVID-19 vaccine, the retail pharmacy company is prepared to offer the vaccine in states where it is able to do so.
"In accordance with FDA approval and state requirements, we will offer the vaccine to all adults ages 65 years and older as well as to individuals under 65 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19," the Walgreens spokesperson said.
Patients can review their vaccine eligibility and schedule their vaccines by speaking directly with their local Walgreens pharmacists, or visiting Walgreens.com/ScheduleVaccine, using the Walgreens app, calling 1-800-WALGREEN or texting FLU to 66879.
Many public health experts and physicians are concerned that the new federal guidance on who the COVID shots are approved for is creating confusion for patients and providers.
"There are more unknowns than knowns," said Bruce Farber, M.D., chief of public health and epidemiology at Northwell Health.
Confusion about changing federal policies on COVID vaccines also comes amid a major leadership shakeup at the CDC. Late last week, the Department of Health and Human Services (HHS) named Jim O'Neill, currently a deputy HHS secretary, as interim director to lead the CDC after Susan Monarez, Ph.D., was fired from her position at the helm of the agency.
In the past few months, there have been steady shifts in vaccine policy and the overall healthcare agenda under the Trump administration. In May, HHS Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines would no longer be recommended for healthy children and pregnant women. But the CDC added a provision to the immunization schedules for shared clinical decision-making. The guidance applies to children ages 6 months to 17 years who are not moderately or severely immunocompromised.
RFK Jr. also revamped the CDC's vaccine advisory committee, ACIP, by tossing all 17 members and replacing them with eight appointees with ties to vaccine skepticism.
"There's [an] enormous amount of distrust of that committee by traditional vaccine experts in the infectious disease community," Farber noted.
Many medical organizations have pushed back against RFK Jr.'s vaccine decisions and issued their own clinical recommendations. The American College of Obstetricians and Gynecologists (ACOG) "strongly recommends" that pregnant women continue to get COVID vaccines. The American Academy of Pediatrics (AAP) recommends the shots for all children ages 6 months to 2 years, contradicting RFK Jr.’s decision.
"Quite frankly, I think most physicians will listen to these medical organizations and not updated CDC recommendations that were done by many people who have no experience and no knowledge of vaccines," Farber said.
The restrictions on who is eligible to get COVID shots creates more roadblocks for patients as vaccination rates continue to drop. As of late April, 23% of adults in the U.S. had received the 2024–25 updated COVID-19 vaccines while only 13% of children have received an updated shot, according to CDC data.
"It's a way of slowly preventing people from getting the vaccines," Farber said. "It leads to a lot of unknowns and hurdles and insurance issues into an already difficult vaccine to sell. The bottom line is, most likely, less people will get it."
Most people have been exposed to the virus, either through vaccination or infection, and have developed some immunity, public health experts say.
But COVID is still a threat to many populations and can lead to severe illness and hospitalizations. And, patients who contract COVID are at risk of developing long COVID. According to the CDC, groups of people more likely to develop long COVID include women, Hispanic and Latino people, people who have experienced more severe COVID-19 illness and individuals who did not get a COVID-19 vaccine.
"To me, not even allowing people who are at low risk, but not zero risk, from getting the vaccine is a great concern," Walter Orenstein, M.D., professor emeritus of infectious diseases at the Emory University School of Medicine, told Fierce Healthcare. "Unfortunately, vaccine-induced immunity wanes and your immune response against the newer variants may not be effective."
"At a minimum, I would want to have shared clinical decision making," to enable patients to get the vaccine after discussing it with their doctor, said Orenstein, who served as director of the U.S. immunization program at the CDC from 1988 to 2004.
"COVID-19 vaccines remain our best tool to prevent severe disease, hospitalization and death due to COVID-19—for healthy adults, children, pregnant patients and others at higher risk," Tina Tan, M.D., president of the Infectious Disease Society of America, said in a statement. "The scientific evidence continues to strongly support broad vaccination far beyond the limited populations outlined in the Food and Drug Administration’s new label."
"By narrowing its approval, FDA has made a decision that 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," Tan said.
The FDA's move to narrow eligibility to only “high-risk” groups marks a major shift from previous years, which encouraged widespread uptake to reduce community spread and increase ease of use, according to Katelyn Jetelina, Ph.D., an epidemiologist, data scientist and author of the popular newsletter “Your Local Epidemiologist."
Because the revised FDA label wasn't finalized until late August, it has left insurers, providers and the public "in the dark," she wrote in her newsletter.
"This is a problem because insurers don’t know who to cover. Doctors are unsure who to prioritize. Pharmacies are uncertain about the number of doses to order and whether their staff can administer them. Vaccine campaigns are stalled," Jetelina wrote.
While the FDA licenses vaccines, the CDC, based on advice from ACIP, sets the schedule for which vaccines people should get and at what ages they should get them.
Recommendations and vaccine schedules developed by the ACIP are tied to private and some public insurance coverage obligations and, in some states, can affect which shots can be administered by pharmacists or other practitioners. Vaccines given outside of the panel’s recommendations can also bring higher liability risks in case of safety events.
"There is no national recommendation on who should get the updated COVID-19 vaccine this fall," Jetelina wrote, noting that the ACIP typically meets in June to make recommendations.
"This is a big deal because the ACIP recommendation is linked not only to insurance coverage requirements but also to the number of doses health systems order in July (to be at clinics by the end of August). It is also linked to standing orders for pharmacists and other state-based authorities to administer the Covid-19 vaccine this fall," Jetelina wrote.
Whether COVID-19 shots will be covered by health insurance for all patients remains an open question.
Tina Stow, a spokesperson for AHIP, the health insurance industry trade group, said, “We’re working closely with our members to review the FDA announcement and will be monitoring the forthcoming meetings and recommendations from ACIP and CDC on considerations around coverage. Individual health plans and plan sponsors will be prepared to make coverage decisions informed by science, the latest medical evidence and data. This process will be evidence-based, evaluate multiple sources of data, including but not limited to ACIP, and will be informed by customer needs."
While doctors could technically prescribe the COVID-19 shot off-label, that has not been the practice with vaccines. Insurers may not cover off-label use, Jetelina wrote in her newsletter, and many physicians also won't administer it off-label because of perceived liability challenges and confusion. "So while a provider could prescribe it off-label, in practice, it’s likely that most people won’t be able to access it that way," Jetelina wrote.
The ACIP is scheduled to meet September 18-19, and COVID-19 vaccines are on the agenda. But that meeting is uncertain.
U.S. Senator Bill Cassidy, M.D., R-La., chair of the Senate Health, Education, Labor and Pensions Committee, called for that meeting to be indefinitely postponed “until significant oversight has been conducted,” noting that “any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership.”
Many physicians point out that a lack of insurance coverage would create financial barriers for patients. Without insurance coverage, the COVID vaccine can cost up to $140, according to the CDC's vaccine price list.
"There shouldn't be any barriers to access. That was the greatness of the initial rollout, removing all barriers to access," Orenstein said. "Now there is a substantial barrier to access, and it impacts not only people who can't be vaccinated, as there may be more transmission going around."
The CDC’s ACIP typically votes to recommend an FDA-approved vaccine for use in specific populations, when it is then added to the Immunization Schedule. Health plans cover ACIP-recommended vaccines without cost sharing, in line with federal requirements as part of the Affordable Care Act (ACA) and the Inflation Reduction Act. Insurance companies also take into account clinical recommendations from medical organizations, like the ACOG and the AAP, when it comes to providing access to evidence-based treatments like vaccines.
Vaccines with recommendations for shared clinical decision-making from the ACIP are also required to be covered at no cost for those with commercial insurance.
Once the ACIP makes a recommendation, Medicare, Part D and Medicaid plans must adhere with ACIP recommendations immediately upon the CDC director’s signature and provide coverage of these vaccines at no cost to the beneficiary. Under the ACA, for commercial plans, any changes stemming from subsequent ACIP recommendations could only be implemented in the next benefit year, according to AHIP.