Op-Ed: Vaccine Policy Changes Are Undoing Pharmacy Access

The COVID-19 pandemic ushered in an era of progress for pharmacists, expanding their role from vaccinators to frontline public health providers, catalyzed by federal emergency measures. This evolution, which saved countless lives during the pandemic, is now facing significant legal and operational setbacks. Recent federal policy shifts, which align with the perspective of US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and FDA Commissioner Marty Makary, MD, MPH, have created a chaotic environment that is directly undermining these advancements and creating a chilling effect on the profession.

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Although these actions have been defended by officials like White House Press Secretary Karoline Leavitt and Commissioner Makary, in reality, progress toward pharmacy-based health care delivery is diminishing rapidly.^1,2

The Pandemic As a Catalyst for Change

Pharmacists’ legal scope of practice (SOP) varies across the United States.³ Although pharmacists develop many skills and competencies through education and training, a pharmacist can only legally provide services when authorized by state law. In recent decades states have greatly expanded SOP for pharmacists to match their professional capabilities. Because 9 out of 10 Americans live within 5 miles of a community pharmacy, this expansion has helped address serious access barriers, provided an effective health care safety net across the country, and extended the medical home.⁴

One of the most visible examples of this shift has been vaccination. The role of pharmacies in immunization has grown steadily since the Centers for Medicare and Medicaid Services (CMS) began allowing roster billing under Medicare Part B for influenza vaccines in the 1990s, a policy later expanded to include other respiratory vaccines.⁵ Likewise, as new adult vaccines emerged and received coverage under Medicare Part D, also known as the pharmacy benefit, states further expanded SOP to align with these changes. Finally, the COVID-19 pandemic accelerated pharmacists’ role when the Trump administration again expanded pharmacist SOP to meet urgent public health needs.⁶

On February 2020, then–Secretary Alex Azar issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) for COVID-19, amended several times.⁷The Third Amendment (August 2020) authorized state-licensed pharmacists to administer CDC Advisory Committee on Immunization Practices (ACIP)–recommended childhood vaccines to patients 3 to 18 years of age.⁸ The Seventh Amendment (March 2021) broadened who could give COVID-19 vaccines to include pharmacy technicians and interns under supervision, as well as pharmacists whose licenses had lapsed within the past 5 years.⁹ The Eighth Amendment (August 2021) allowed pharmacists, technicians, and interns to administer influenza vaccines to adults, while the Ninth Amendment (September 2021) extended their authority to administer monoclonal antibody treatments for COVID-19.^10,11

These Declarations leveraged the PREP Act’s preemptive power to override state-level SOP limitations and establish a federally unified SOP for certain vaccines. The PREP Act also provided liability protections for “qualified persons,” like pharmacists, administering these vaccines through the Countermeasures Injury Compensation Program, separate and apart from the Vaccine Injury Compensation Program (VICP).

Broadened SOP coupled with liability protections empowered pharmacists to serve as accessible, highly trained providers nationwide and enabled the largest adult vaccination program in US history. During the pandemic, approximately half of all Americans received their COVID-19 vaccines in pharmacies and pharmacy vaccination for other vaccines also reached record highs—a trend that was sustained even after the public health emergency ended.¹²

As these temporary federal authorizations took effect, several states codified expanded pharmacist SOP into their own laws, ensuring continuity of access. Nonetheless, when the public health emergency expired on May 11, 2023, pharmacists in some states lost federal authorization to administer pediatric vaccines as well as their authority to provide monoclonal antibodies.¹³ From that point forward, state laws again became the controlling source for pharmacist, technician, and intern SOP. As discussed earlier, the landscape remains fractured: some states condition pharmacist SOP upon FDA approval or authorization language whereas others tie SOP to ACIP recommendations.

With respect to COVID-19 vaccines, currently under the Twelfth Amendment (December 2024), pharmacists, technicians, and interns are considered “qualified persons” until December 31, 2029. However, expanded SOP and liability protections afforded by the PREP Act only apply to this group for “FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages 3 or older … ordered and administered according to CDC's/ACIP's COVID-19 vaccine recommendation(s).”¹⁴

Undermining Progress in the Pharmacy

The momentum gained during the pandemic is now at risk due to recent federal actions to roll back vaccine policy. Until recently, the COVID-19 vaccines were authorized for use via Emergency Use Authorization (EUA) in all individuals 6 months of age and older or approved via Biologics License Application (BLA) for individuals aged 12 and older. ACIP also routinely recommended the use of the COVID-19 vaccine in all individuals aged 6 months of age and older. This means that under the PREP Act, and under most state SOPs, pharmacists could vaccinate most Americans against COVID-19.¹⁵

In May 2025, however, Commissioner Makary and Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, introduced a new regulatory framework that would narrow FDA approval of all future COVID-19 vaccines to individuals under 64 years of age with an underlying condition that puts them at risk for severe COVID-19 or individuals over 65.¹⁶ The FDA applied this regulatory framework for the Novavax vaccine, limiting it to individuals aged 12 to 64 years of age with an underlying condition that puts them at risk for severe COVID-19 or individuals over 65.¹⁷ At the same time, Secretary Kennedy issued a directive instructing the CDC/ACIP to remove the vaccine from the immunization schedule for pregnant women and healthy children.¹⁸

This change in the CDC/ACIP recommendations meant that, under the PREP Act and in states that tied SOP to CDC/ACIP recommendations, pharmacists no longer had SOP or liability protections to vaccinate pregnant patients or healthy children. However, in states that tied SOP to FDA-authorizations or FDA-approval language, pharmacists could still vaccinate these groups for COVID-19.

In July, the FDA again applied the regulatory framework to the Moderna vaccine, narrowing its indication to individuals aged 6 months to 64 years of age with an underlying condition that puts them at risk for severe COVID-19 or individuals over 65.¹⁹

Despite this, in some states, pharmacy-based access to COVID-19 vaccines continued for most adults under existing EUAs and through Pfizer’s BLA for all individuals 12 and older. That changed in August 2025, when the FDA simultaneously revoked all EUAs and applied the regulatory framework to the Pfizer vaccine, limiting it to individuals aged 5 to 64 years of age with an underlying condition that puts them at risk for severe COVID-19 or individuals over 65.^20,21

This move has cut off pharmacy-based access to the COVID-19 vaccines for all healthy Americans under 65 years of age and placed pharmacists at the center of the resulting access crisis.

Shrinking Legal Safeguards for Vaccinating Pharmacists

With the revocation of the EUAs, there are no longer FDA-authorized COVID-19 vaccines and pharmacists must vaccinate according to the FDA label. Unlike physicians, who may generally prescribe “off-label” without consequence, pharmacists have little to no leeway to act outside these parameters. Doing so would strip them of PREP Act liability protections and could even expose them to state disciplinary action. The risk is heightened by the fact that COVID-19 vaccines are not covered by VICP, leaving pharmacists especially vulnerable to vaccine-related lawsuits.

To limit liability, pharmacists must stay within the confines of the narrowed FDA approval, meaning pharmacists must somehow determine whether a patient under 65 has an underlying health condition before ordering and administering a COVID-19 vaccine. Given the high demands already placed on pharmacists and lack of adequate resources, assessing underlying health conditions at the pharmacy counter is challenging, especially for more complex patient scenarios.

This is further complicated in pediatric patients because each commercially available COVID-19 vaccine has a different age indication, which may not align with the products the pharmacy has in stock. With COVID-19 vaccination volumes far lower than at the pandemic’s height, few pharmacies carry every brand and ordering habits are unlikely to change with these new limitations in place.²² Together, these factors significantly complicate pharmacy operations and result in diminished vaccine availability.

Additionally, while the current CDC ACIP immunization schedule includes a routine recommendation for healthy adults, this is likely to be curtailed at the next ACIP meeting in light of the recent FDA changes, further constraining pharmacy-based vaccination.²³

Given this confluence of factors, pharmacists are finding themselves in a legal gray area and are erring on the side of caution to avoid liability risk. Consequently, many pharmacists will likely refer patients back to their physician for a prescription before vaccinating or urge patients to receive a vaccine in the physician’s office, an approach which risks patient frustration and attrition. In practice, absent persistent effort from patients, many individuals will forgo vaccination altogether.

After the August 2025 changes, a New York Times story revealed that Walgreens' website requires a prescription for a COVID-19 vaccine in 16 states, and CVS has similar requirements in 13 states and DC.²⁴ However, this remains a fluid situation.

Within the past week, several states have moved to expand pharmacist SOP to permit continued COVID-19 vaccination regardless of FDA approved indication or ACIP recommendations. Some now allow pharmacists to follow guidance issued by professional societies such as the American Academy of Pediatrics (AAP) and American College of Obstetricians and Gynecologists (ACOG). For example, Massachusetts issued a new standing order for COVID-19 vaccines and the Pennsylvania Board of Pharmacy updated its regulations.^25,26 Although these are steps in the right direction, pharmacist SOP is more fractured than ever.

Diminished Vaccines Access and the Pharmacist’s Role

The consequences of the recent narrowing of FDA authorizations and approvals has automatically created a 2-tiered system for vaccine access. Healthy people under 65 now face myriad added steps. The result will be a further decline in already low COVID-19 vaccination rates, with collateral damage to uptake of other vaccines. This comes at the worst possible moment as a new COVID-19 variant, called “Stratus,” is driving cases higher and the country heads into respiratory virus season.²⁷

The current legal and operational uncertainty underscores how fragile the pandemic-era gains in pharmacy-based vaccination truly are. This situation has also revealed that state SOP laws and regulations are the gatekeepers for what pharmacists can provide, meaning that patient access to vaccines depends less on medical need and more on geography. Pharmacies remain one of the most important and accessible entry points to care, and policymakers should keep state SOP front of mind, not only to sustain vaccination access, but also to strengthen pharmacies’ broader role in delivering essential health services.

REFERENCES

1. Reporter Aska Leavitt: Does Trump Believe COVID Vaccine Should Be ‘Available’ To All Americans? [YouTube]. Forbes Breaking News. August 29, 2025. Accessed September 15, 2025. https://www.youtube.com/watch?v=K-ASi4zENFM

2. Dr Makary Clip, FDA Does Not Have Enough Data [YouTube]. VNNChannel. September 1, 2025. Accessed September 15, 2025. https://www.youtube.com/shorts/wUBwK1nVdhw

3. Pharmacist and Pharmacy Technician Vaccination Authority. National Alliance of State Pharmacy Associations. September 3, 2024. Accessed September 15, 2025. https://naspa.us/resource/2024-pharmacist-immunization-authority/

4. 9 out of 10 Americans live close to community pharmacy. News release. University of Pittsburgh Health Sciences. July 28, 2022. Accessed September 15, 2025. https://www.upmc.com/media/news/072722-community-pharmacy

5. Gornick ME, Warren JL, Eggers PW, et al. Thirty years of medicine: impact on the covered population. Health Care Fin Rev. 1996;18(2).

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7. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Federal Register. March 17, 2020. Accessed September 15, 2025. https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

8. Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Federal Register. August 24, 2020. Accessed September 15, 2025. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.govinfo.gov/content/pkg/FR-2020-08-24/pdf/2020-18542.pdf

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10. Eighth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Federal Register. August 4, 2021. Accessed September 15, 2025. https://www.federalregister.gov/documents/2021/08/04/2021-16681/eighth-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for

11. Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Federal Register. September 14, 2021. Accessed September 15, 2025. https://www.federalregister.gov/documents/2021/09/14/2021-19790/ninth-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical

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13. Immunizations by Pharmacists Ending After the Public Health Emergency Expires. Partners for Kids. May 31, 2023. Accessed September 15, 2025. https://partnersforkids.org/news-updates/immunizations-by-pharmacists-ending-after-the-public-health-emergency-expires/

14. Twelfth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Federal Register. December 11, 2024. Accessed September 15, 2025. https://www.federalregister.gov/documents/2024/12/11/2024-29108/12th-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical

15. Use of COVID-19 Vaccines for Persons Aged > Months: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024-2025. CDC Morb Mortal Wkly Rep MMWR. 2024;73(37):819-824.

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23. Meeting of the Advisory Committee on Immunization Practices. Federal Register. August 29, 2025. Accessed September 15, 2025. https://www.federalregister.gov/documents/2025/08/29/2025-16706/meeting-of-the-advisory-committee-on-immunization-practices

24. Astor M, Blum D. CDC uncertainty upends Covid vaccine access at CVS and Walgreens. New York Times. August 28, 2025. Accessed September 15, 2025. https://www.nytimes.com/2025/08/28/well/cvs-pharmacy-covid-vaccine-16-states.html

25. Standing Order for Dispensing and Administration of COVID-19 Vaccine: 2025-2026. Accessed September 15, 2025. chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.mass.gov/doc/signed-standing-order-for-dispensing-and-administration-of-covid-2025-2026/download

26. State Board of Pharmacy Important Notice Regarding Immunizations 9/5/2025. Commonwealth of Pennsylvania. September 5, 2025. Accessed September 15, 2025. https://www.pa.gov/agencies/dos/department-and-offices/bpoa/boards-commissions/pharmacy

27. Scribner H. What to know about rising COVID-19 cases and the surging “stratus” variant. Axios. August 8, 2025. Accessed September 15, 2025. https://www.axios.com/2025/08/08/covid-19-stratus-variant-symptoms-cases-cdc