On January 31, 2020, the U.S. Secretary of Health and Human Services declared the 2019 novel coronavirus disease (COVID-19) a public health emergency in the United States.¹ By December 2020, COVID-19 has resulted in 480,000 hospitalizations and 350,000 million deaths in the United States alone.² The Food and Drug Administration (FDA) authorized and the Advisory Committee on Immunization Practices (ACIP) recommended the first COVID-19 vaccines in December 2020.³ ACIP continued to update population-based recommendations for COVID-19 vaccination based on evolving vaccine and epidemiology data. ⁴ Establishing innovative partnerships and implementing programs to support vaccination were needed. Vaccination has been a highly effective public health intervention to prevent illness, mitigate the burden of infections, and minimize the morbidity and mortality being caused by COVID-19.^5,6 The Centers for Disease Control and Prevention (CDC) along with several federal agencies and partners helped implement the nation’s largest vaccine distribution program in U.S. history. ⁷

Knowing that pharmacies are readily available in communities across the United States, with 90% of U.S. residents living within 5 miles of a pharmacy ⁸, and pharmacists are well-trained in providing vaccination services ⁹, the United States government (USG) launched the Federal Retail Pharmacy Program (FRPP), a collaboration between the U.S. government and 21 national retail and independent network pharmacy partners to build a robust and equitable vaccination program. ¹⁰ Expanding sites where people could get vaccinated by reducing their distance to professionals who could administer vaccinations were key strategy components to increase vaccine uptake, and pharmacists and their teammates took a leading role in the national vaccination strategy. This was not the first time that pharmacies participated in vaccination efforts. Pharmacists have administered an increasing proportion of adult vaccinations since the 1990s. ^11-14 For example, pharmacists immunized nearly a third of all adults vaccinated for influenza in the 2018-2019 season¹⁴ and administered approximately 10% of all H1N1 vaccinations during the 2009 Influenza A H1N1 pandemic. ^23,24

Previously published CDC report estimated that as of August 18, 2023 and as a result of the USG’s efforts and partnerships with pharmacies during the COVID-19 pandemic, FRPP administered more than 307 million COVID-19 vaccine doses in the United States. ¹⁵ To better understand the role FRPP played during the COVID-19 public health emergency, this study evaluated the contribution of FRPP to COVID-19 vaccination efforts in the United States from December 2020 through September 2023.

A total of 644.1 million COVID-19 vaccine doses were administered from December 13, 2020 to September 30, 2023 in the United States. The number of COVID-19 vaccine doses administered varied over time with the highest monthly uptake occurring in April 2021, November 2021, and October 2022 (Figure 1). The FRPP administered approximately 314.9 million or 48.9% COVID-19 vaccine doses throughout this period. COVID-19 vaccine dose uptake through FRPP providers mirrored uptake throughout the all-provider trend. Table 2 in the supplementary appendix summarizes selected events in COVID-19 vaccination policy revisions throughout the pandemic. ³ The total number of all-provider sites administering COVID-19 vaccines was estimated to be at least 125,000. The total number of sites administering for FRPP was at least 47,000, including 37,545 (79%) chain pharmacies and 9,987 (21%) pharmacies operating as part of independent pharmacy networks. Among the 59 jurisdictions administering COVID-19 vaccine, all but five (American Samoa, Federation of Micronesia, Palau, Marshall Islands, Northern Mariana Islands) had FRPP sites.

Comparison among both data sources for COVID-19 vaccine doses administered by age, sex, race and ethnicity, and urbanicity of administration site are summarized in Table 1. For both FRPP and all-provider sites, the highest percentage of doses were given to persons aged 18-49 years (39.9% and 38.1%, respectively), females (53.6% and 52.9%, respectively), Non-Hispanic White persons (42.0% and 48.3%, respectively), and in urban locations (91.3% and 89.1%, respectively). The lowest percentage of doses administered, also for both data sets, were doses given to persons aged 6 months to 4 years (0.2% and 0.7%, respectively), males (46.3% and 46.5%, respectively), and Non-Hispanic Native Hawaiian or Pacific Islander persons (0.2% and 0.3%, respectively). It is worth noting that the FRPP reported more vaccine administrations with unknown race and ethnicity (29%) than the all-provider data (19%).

FRPP partners administered almost half of all COVID-19 vaccine doses across the United States from December 2020 through September 2023. FRPP rapidly increased COVID-19 vaccine accessibility in the United States, especially after summer 2021, when many state-coordinated mass-vaccination clinics were closing. ¹⁹ Indeed, from September 2021 through September 2022, during distribution of the bivalent mRNA COVID-19 vaccines, FRPP pharmacies administered 67.7% of all COVID-19 vaccinations. ²⁰ Throughout the pandemic, differences were seen in the utilization of FRPP partner vaccination services across age groups, race/ethnicity, and urbanicity of the administering provider. In addition to administering most doses for the age groups 12 years to 65 years, FRPP administered a substantial percentage of doses given to persons aged 65 years and older (46.4%) and 5—11 years (38.5%). Even though not substantially, FRPP still supported vaccinating children as young as 3 to 4 years. This was possible due to the third amendment to the Public Readiness and Emergency Preparedness Act (PREP Act) which authorized licensed pharmacists and pharmacy interns to administer ACIP recommended vaccines for children as young as 3 years, overriding any state laws. ²¹ FRPP supported several racial and ethnic minority groups demonstrating the substantial programmatic advancement of the federal retail pharmacy program to provide equitable access to COVID-19 vaccines. However, our analyses found that FRPP partners vaccinated a lower proportion of Non-Hispanic American Indian and Alaska Native persons, which may be due to these population groups receiving more of their vaccinations from other vaccination providers such as the Indian Health Service. In addition, FRPP contributed to a higher proportion of COVID-19 vaccinations in urban (57%) than rural counties (45%).

In preparation for the COVID-19 vaccine Emergency Use Authorization (EUA), USG launched a collaboration with three pharmacy organizations, known as the Pharmacy Partnership for Long-Term Care Program (PPP) in December 2020. In February 2021, PPP efforts were expanded to include a total of 21 federal retail pharmacy organizations, referred to as the Federal Retail Pharmacy Program (FRPP). FRPP represented over 46,000 pharmacy providers and created increased opportunity for COVID-19 vaccination in the United States. ¹⁰ Prior to the pandemic and launch of FRPP, vaccinations were primarily administered at provider sites such as health departments, medical offices, healthcare systems, independent and chain pharmacies, community and federally qualified healthcare centers, and other federal agencies. These provider sites continued to contribute to vaccination efforts during the COVID-19 pandemic.

Prior to the COVID-19 pandemic, providers, including pharmacies, submitted their routine administration data to state and local immunization information systems (IIS) whose requirements and policies varied across jurisdictions. ²² During the COVID-19 emergency response, expanded federal authorities allowed the CDC to require partners to report doses administered in alignment with the CVRS to the CDC Data Clearinghouse (DCH), a federal application developed specifically for the submission of all COVID-19 vaccine administrations. ¹⁰ CDC provided continuous support to help partners prepare their data management systems to collect and report vaccine administrations. ¹⁰ COVID-19 vaccine administration data were initially reported to CDC daily to establish a centralized national surveillance system with timely COVID-19 immunization data to inform vaccine distribution and vaccination efforts. The cadence of COVID-19 vaccine administration reporting was later adjusted to weekly, and then monthly, to reduce the burden on partners.

COVID-19 vaccine administration trends across all-provider and FRPP data fluctuated in a similar pattern following evolving pandemic needs and updates in vaccine recommendations (Figure 1). This showed that FRPP, just like all other providers, was able to accommodate evolving needs of the pandemic as vaccine recommendations expanded. Also, FRPP started with about 10,000 vaccination sites in February 2021, and expanded to more than 35,000 by mid-April 2021. ²³ Figure 1 showed that out of the three highest peaks for COVID-19 doses administered (occurring during April 2021, November 2021, and October 2022), the latter two had majority of their doses administered by FRPP. This could probably be due to the fact that by November 2021, vaccine supply was more abundant, USG recommended pharmacies offer walk-in services in addition to scheduled appointments, and mass vaccination clinics had closed.¹⁹ Also, after June 2021 was the time when FRPP partners had expanded to include more than 46,000 vaccination sites. Previously published CDC data also demonstrated that during the bivalent COVID-19 vaccination campaign, from September 2022 to September 2023, FRPP partners were the primary administration sites for vaccination for most age groups. ²⁰

Pharmacies are readily accessible brick-and-mortar structures across the United States and can serve as an important resource to expand vaccination efforts. During the public health emergency, pharmacies also served and offered offsite clinics and mass vaccination clinics to make COVID-19 vaccine more accessible.¹⁰ The volume of FRPP administered doses reinforces pharmacies as an important partner to immunization campaigns seeking to increase vaccination in the United States.¹² Pharmacies have been leveraged in the past to expand pandemic influenza vaccination during the 2009 influenza A (H1N1) pandemic. During the 2009 H1N1 pandemic, pharmacies administered approximately 10% of all H1N1 vaccinations. ^24,25 Lessons learned from this initiative can be used to guide opportunities with pharmacies that optimize community-level vaccination planning, implementation, and evaluation with both federal and state/local health department partners. ^14,24-27.

Many rural counties have limited health access points, and oftentimes disproportionately experience poor health outcomes. Obstacles to health access points represents a challenge to public health prevention activities in many rural population groups. Findings from our study suggest that FRPP pharmacies extended vaccination intervention reach across urban and rural areas. The higher percentage of COVID-19 doses administered in urban areas for both FRPP (91.3%) and all-provider data (89.1%) (Table 1) aligns with the fact that most of the U.S. population (85.2%) live in urban counties as described in the 2013 NCHS scheme. ¹⁸Geography can influence proximity to healthcare and public health services and functions as an important dimension to the social determinants of health, reflecting reduced care access opportunities and producing downstream impacts on health outcomes. Additional explorations are warranted to characterize program and policy implementation components of the FRPP pharmacy partnership that supported enhancing local-level vaccination access across the rural U.S. ^28,29

The scale and complexity of the COVID-19 pandemic vaccine program required the largest vaccine distribution in the US history. FRPP data showed that pharmacies scaled up and contributed to a high percentage (48.9 %) of vaccinations across the United States, administering COVID-19 doses to persons across various sociodemographic characteristics. These findings add to the existing evidence of FRPP contributions beyond the COVID-19 mRNA campaign. ¹⁹ It is worth noting that some pharmacies who were not participating in FRPP were also administering COVID-19 vaccines allocated from their respective jurisdictions. Previous studies have shown that there are around 62,000 pharmacies in the United States.⁸ Knowing that around 47,000 pharmacies (75%) were participating in FRPP, the contribution of pharmacies nationwide could even be more prominent if vaccination efforts of pharmacies not participating in FRPP were accounted for or if more pharmacy sites were able to participate in this program.¹⁰

Factors enabling community pharmacies to rapidly scale up included trust, longstanding training and experience administering vaccinations, proximity to most U.S residents, convenience of hours of operation, ability to deliver critical health education and immunization services to walk-in patients, and their capability to provide services when other healthcare providers were closed.^24-27,30 Pharmacists were already equipped to offer clinical services including vaccination, but their role and authority was expanded during the COVID-19 pandemic.²¹ Additionally, pharmacies had to adjust hours of operation and staffing to adapt to restricted patient contact and infection-control measures while meeting vaccination demand.¹⁹ Finally, FRPP partnership provided an efficient platform to leverage existing supply chain systems to distribute vaccines to local pharmacies ¹⁹and accommodate the ultra-low temperature storage requirements on a large scale. Even though FRPP officially ended with the end of the public health emergency, the legacy continues and based on interviews conducted by CDC between January until March 2024, 71.5% of vaccinated adults reported receiving their updated COVID-19 vaccine in a pharmacy.³¹ As CDC continues to build upon successes and lessons learned from the FRPP model, future implementation considerations could include strengthened data collection on race, ethnicity, and other social determinants among vaccination recipients at pharmacy sites. The collection of additional social risk data could support a better understanding for where inequitable vaccination access opportunities exist and reveal characteristics about the populations disproportionately impacted. Pharmacists, pharmacy support staff, and other vaccination providers are well primed as trusted champions to accelerate culturally competent health education activities focused on vaccine awareness, and when combined with the use of strong data for action, provides a roadmap toward improved vaccination access and uptake during any future large scale public health emergency.

FRPP partners were critical in expanding access to COVID-19 vaccination services throughout the United States. This partnership proved to be an effective model to address vaccination administration needs during emergency responses and with the constantly evolving recommendations. Although the pandemic has ended, the need for ensuring equitable access to all recommended vaccines, including COVID-19 vaccines, remains. ³² Public-private partnerships, like the FRPP, could be a suitable channel to address future vaccine-preventable disease emergencies. Continuing active partnerships between public health entities in the United States with private vaccination partners, for routine vaccinations, emergency preparedness training, and collaboration on emergency responses will further prepare the U.S. for future responses to public health crises. ³³