The Trump administration’s vaccine policies are confusing, to say the least, particularly for the COVID vaccine. Health and Human Services Secretary Robert F. Kennedy Jr. told a Senate committee last month that anyone who wants a COVID vaccine can get one. But senators from both parties said Kennedy’s policies were effectively preventing access to the shot, citing incidents of people being turned away at pharmacies.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) met last month, but some of its members—all selected by Kennedy—were themselves confused on how the panel’s actions affected vaccine access. Pharmacists have scrambled to determine if they are authorized to provide COVID vaccines and who is eligible to receive them.
COVID vaccine access involves a complex web of federal law, national public health guidance, and state regulations that has left even health policy scholars scratching their heads. The confusion is partly the product of a national vaccination system that has been largely unified in practice despite legal and technical distinctions between state and the federal authorities. As the Trump administration has leaned into broader skepticism about vaccines and moved to restrict federal approvals and recommendations for the COVID vaccine, the system has begun to fragment.
Today, the COVID vaccine is broadly accessible on paper, but the confusion surrounding the administration’s policy changes has erected barriers to access in practice, particularly at pharmacies, where roughly 90 percent of COVID vaccinations last year were administered.
How did this evolve? The policy changes began in May when Kennedy unilaterally restricted the CDC’s COVID recommendations. He rescinded the agency’s guidance for routine COVID vaccination for healthy children, but the CDC modified the change days later to recommend that the decision to vaccinate children between 6 months and 17 years old be discussed with a health care provider. Kennedy also rescinded the CDC’s recommendation for pregnant women to receive the COVID vaccine, effectively removing the vaccine from the schedule entirely.
Even though the CDC’s guidance involves recommendations rather than mandates, virtually every state pegs its vaccine policies in some way to the CDC immunization schedule and or ACIP recommendations, including what vaccines pharmacists are allowed to administer. After Kennedy’s changes, reports soon emerged of pregnant women being repeatedly denied access to the vaccine at pharmacies despite recommendations from their doctors to get the shot.
“Unlike physicians, nurse practitioners, and physician assistants, pharmacists’ authority to vaccinate is based on state legislators, state statutes, and state regulations,” Allison Hill, the American Pharmacists Association’s (APhA) director of professional affairs, told The Dispatch. “Most of those state regulations either allow pharmacists to administer [Food and Drug Administration] approved vaccines or ACIP recommended vaccines.” If healthy pregnant women are a population no longer included in the CDC’s recommendations, then pharmacy access is imperiled.
The next big change came in August when this year’s updated COVID shots were coming online. Vinay Prasad, a Kennedy ally and senior Food and Drug Administration (FDA) vaccine official, overruled agency scientists and approved the vaccines only for people over 65 or those with underlying conditions putting them at risk of severe COVID. The FDA normally determines only whether a vaccine is safe and effective, and doesn’t comment on public health recommendations for the vaccine’s deployment.
The change effectively made administering the shot to anyone else “off label.” And because many state regulations prevent pharmacists from providing off-label shots without a prescription, the FDA’s limited approval initially resulted in barriers to access for healthy people in large states like Florida and New York and more than a dozen others.
Access was also limited by the timing gap between the FDA’s approval and a subsequent ACIP meeting on September 18-19 to consider recommendations for the year’s updated vaccines. The prevalence of state laws relying on ACIP recommendations meant that many pharmacists could not administer the latest vaccine until the committee recommended the new shots; in 2023, the panel issued recommendations the day after FDA approval.
But when ACIP met, its recommendation—that anyone 6 months and older consult with a provider about COVID vaccination—diverged from the FDA’s guidance. ACIP’s recommendation was broader, including healthy people that were excluded by the FDA’s approval. But the committee also added the additional step of a provider consultation for people over 65 before getting the shot whereas the FDA simply approved the vaccine for that cohort.
Public health researchers are uncertain about what ACIP’s updated recommendations mean for healthy pregnant women, a group excluded by Kennedy’s changes to the schedule in May. Jennifer Kates, a senior vice president at the Kaiser Family Foundation, told The Dispatch that it’s ambiguous, but her understanding of the ACIP vote is that pregnant women are included in the broad recommendation. Dorit Reiss, a law professor at the University of California San Francisco whose work focuses on vaccine legal issues, told The Dispatch she doesn’t think ACIP intended to include pregnant women in its votes, noting the committee did not expressly address Kennedy’s previous changes. The chair of ACIP’s COVID working group seemed to suggest during the meeting that the votes did not address the issue of vaccination for pregnant women.
The Dispatch asked the CDC to clarify whether ACIP’s COVID guidance includes healthy pregnant women. “ACIP’s recommendation applies to all individuals six months and older,” an HHS spokesperson said in response to the request for comment. “It includes an emphasis that the risk-benefit of vaccination in individuals under age 65 is most favorable for those who are at an increased risk for severe COVID-19. High-risk groups [include] those who are pregnant or recently pregnant.”
As a result of the cascading uncertainty, 27 states have now changed regulations to safeguard vaccine access, including allowing pharmacists to administer the COVID vaccine without a prescription and re-anchoring vaccine rules to what medical associations recommend instead of relying on just the CDC or its vaccine advisory panel.
“[States] are giving authority to our pharmacists to do this,” said Kates, who co-authored a recent analysis of state vaccine changes. “It’s basically, ‘Here’s our recommendation that they can give COVID vaccines to anyone ages 3 and older. Or, we are changing … our regulation or language” to align with medical groups like the American Academy of Pediatrics and American College of Obstetricians and Gynecologists.
AHIP, the health insurance industry’s trade association, announced last month that its members would continue to cover vaccines including COVID and flu shots. The announcement came the day before the ACIP meeting, reflecting both a pointed rebuke of the committee and further fragmentation of vaccine policy.
Most people in most states should now technically be able to get the vaccine at a pharmacy. Amy Thibault, a spokeswoman for CVS, said in a statement shared with The Dispatch that the company’s pharmacies currently offer COVID vaccines to most people without a prescription in 48 states. CVS pharmacies in Georgia and Louisiana still require a prescription until the CDC formally adopts ACIP’s recommendations into the agency’s immunization schedule. Thibault added that the minimum age someone must be in order to get the vaccine at a pharmacy will vary by state rules.
Thibault also told The Dispatch that in all 50 states pharmacists are able to fulfill the “clinical decision-making” role of a provider required for COVID vaccination; HHS also said in a statement that pharmacists can serve in that role. When asked whether the new consultation requirement could create workload problems for pharmacists, she said there shouldn’t be challenges: “It’s simply a conversation between the pharmacist and patient to gauge whether the patient has any questions or concerns.” Hill, the APhA director, agreed, saying the additional burden would be marginal but adding that, “It may take a little bit longer than it used to in pharmacies because the pharmacist has to have a conversation with the patient about their overall health status, underlying conditions, and just discussion about the risk and the benefits of getting the vaccination.”
But despite the state changes, confusion and uncertainty about vaccine eligibility and access are still widespread among pharmacists, doctors, and patients alike. What has emerged on the ground is patchwork access with individual pharmacies and pharmacists coming to different conclusions about administering COVID vaccines.
There are continued reports of problems with vaccine access even in states that have adjusted their regulations and at large chain pharmacies, companies presumably best positioned to push out updated guidance to their stores. Independent pharmacy owners also are struggling to track the state and federal changes. “Each store manager is interpreting it differently and maybe each pharmacist is interpreting it differently. In the absence of standard guidance, that’s what happens,” Jennifer Avegno, the director of the New Orleans Health Department, said last week.
Much of the problem is likely due to providers’ uncertainty navigating fragmentation in vaccine policy and fears about taking actions they feel could expose them to liability or risk their licenses. National emergency authorizations and authorities exercised during the pandemic meant that pharmacists didn’t have to worry about state law versus federal guidance or even insurance coverage. “The fact that states had varying policies before, that didn’t matter in the emergency,” Kates said. “Not only was the government providing free COVID vaccines, but pharmacies, and pharmacists were all protected from any liability concern and given broad emergency authority to vaccinate anyone 3 and older, which helped get people very used to going to pharmacies [for vaccines].”
Beyond access issues, the message coming from public health authorities like ACIP is that the vaccine is not recommended as routine, and Trump administration officials and advisers have amplified misleading and inaccurate claims about the risks of the vaccine itself.
Even before the current administration’s messaging on vaccines, the CDC had already begun moving away from recommending that providers and patients simply discuss whether to get the vaccine—a process known as shared clinical decision-making (SCDM)—because the framework created confusion for doctors and patients. For example, last June, ACIP voted to shift its respiratory syncytial virus (RSV) guidance away from SCDM and to routine recommendation for specific groups. ACIP working group members noted that “[c]ompared to universal recommendations, SCDM does not have a clear call to action” and “not all providers who give vaccines are comfortable with SCDM or feel it is within their scope of practice.” They cited a 2021 physician survey that found 76 percent of respondents thought that shared clinical decision-making creates confusion and 42 percent said they didn’t know how to implement it as intended by ACIP.
In August, Kennedy fired CDC Director Susan Monarez—the administration’s own pick who spent just a month on the job. Monarez testified to Congress that she was fired because she refused to preemptively rubber-stamp ACIP’s upcoming recommendations. Monarez was replaced by a senior Kennedy aide who’s currently serving as acting CDC director. But after the latest ACIP meeting, the panel’s updated COVID recommendations—while narrower than past guidance—are broader than the FDA’s and unlike Kennedy’s May changes to the CDC schedule, they appear to include healthy pregnant women.
More uncertainty about vaccine access could follow if Kennedy decides to reject ACIP’s recommendations or issue new CDC recommendations of his own.
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