In March 2020, the World Health Organization (WHO) declared COVID-19 a pandemic [1]. By December 2020, two mRNA vaccines for COVID-19 received emergency use authorization (EUA) from the Food and Drug Administration (FDA) [2]. As of May 2023, >984 million COVID-19 vaccine doses have been delivered in the U.S., with 270.2 million (81.4 %) individuals having received at least one dose [3]. The Centers for Disease Control and Prevention (CDC) COVID-19 Vaccination Program, in coordination with state and local public health efforts, helped to ensure safe and equitable vaccine access and the achievement of this COVID-19 vaccination coverage milestone.

Prior to the commercialization of COVID-19 medical countermeasures to the traditional health care marketplace, all COVID-19 vaccines in the U.S. were purchased exclusively by the federal government. COVID-19 vaccination providers were required to enroll in the CDC COVID-19 Vaccination Program to administer COVID-19 vaccine [4]. The COVID-19 Vaccination Provider Oversight (CVPO) program was implemented to assist the 64 CDC-funded immunization program awardees (described herein as awardees) in supporting enrolled healthcare providers with proper vaccine management (e.g., vaccine storage and handling), administration, reporting, and safety procedures. Increased technical assistance and financial support via awardee supplemental funding were provided to recruit and onboard COVID-19 vaccination providers and address increased staffing needs to manage systems and provider education impacted by multiple COVID-19 vaccine products, frequent changes in Advisory Committee on Immunization Practices (ACIP) recommendations/eligibility, and CDC’s clinical guidelines [5–8].

Beginning in May 2021, awardees were required to conduct site visits with COVID-19 vaccination providers who store and administer vaccine (i.e., “store and administer” provider locations) and depot locations (i.e., any location used to routinely store or redistribute COVID-19 vaccine to multiple locations) for as long as the federal government provided COVID-19 vaccines [9]. The number of annual site visits required of each awardee was determined by the CDC and based on a jurisdiction’s population size. The four primary goals of CVPO program site visits were to 1) assess adherence to program requirements, ACIP recommendations, and CDC guidelines, 2) identify and address provider strengths and challenges, 3) identify and address educational needs, and 4) ensure proper storage and management of vaccines administered [9]. Guidance documents and reviewer resources were developed to support awardee staff in conducting CVPO program site visits. Ongoing awardee and healthcare provider training opportunities as well as technical assistance were provided by the federal government.

We summarize healthcare provider adherence to CVPO program compliance requirements overall and by compliance area from approximately 17,000 awardee-led site visits conducted as part of the CDC COVID-19 Vaccination Provider Oversight program.

The present study assessed CVPO site visit data collected between May 14, 2021, and May 1, 2023. This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy.¹

A total of 18,697 site visits were recorded in REDCap; 1,243 site visit records were excluded due to data incompleteness (i.e., site visit not in “complete” status), missing site visit date information, or because the site visit occurred outside of the study period. Of the 17,454 site visits included in the analysis, healthcare provider compliance was evaluated on the subset of store and administer provider locations; 378 site visits conducted at depot locations or missing a provider function assignment were excluded from the compliance analysis, resulting in 17,076 site visits remaining for this study.

This study found that most healthcare providers that received a COVID-19 Vaccination Provider Oversight program site visit were compliant with program requirements overall and by compliance area. More than 90 % of healthcare providers were compliant with COVID-19 vaccine preparation, administration, and error reporting processes. Non-compliance was higher for vaccine storage and handling and vaccine reporting. Immunization program awardees demonstrated immense capacity to support large-scale monitoring and evaluation of COVID-19 efforts to support oversight of proper vaccine management, administration, and safety.

As part of the Vaccines for Children program (VFC) [12], awardees are required to conduct quality assurance site visits with VFC providers to ensure proper storage, handling, and administration of VFC-purchased vaccines. Modeled after systems used to support the VFC program, healthcare provider adherence to COVID-19 vaccine administration, documentation, accountability, and vaccine management requirements were evaluated over the length of the CVPO program. The present study observed similar areas for non-compliance as has historically been observed for VFC providers (internal data report); vaccine storage and handling and documentation concerns continue to demonstrate the greatest areas of healthcare provider non-compliance. To address these challenges, CDC implements annual training requirements and routinely develops program guidance to support awardee and provider education on proper vaccine management and administration, including vaccine storage and monitoring. Although time and resource intensive, these efforts respond to healthcare provider challenges (e.g., staff turnover, changes in reporting guidance) to ensure the quality of vaccines administered and long-term program integrity.

Over the past decade, the CDC has implemented several measures to improve vaccine management practices. These included stricter temperature monitoring device requirements (e.g., digital data logger requirements) along with enhanced documentation practices for temperature excursions. The CDC’s Storage and Handling toolkit [13] is routinely updated to provide the latest guidance and recommendations for maintaining vaccine integrity and efficacy. Additionally, unannounced site visits focused on assessing provider storage and handling practices were introduced to the VFC program in 2016. While these spot checks were not a component of the CVPO program, they contribute to enhanced oversight of federally-purchased vaccines and could be considered for future federal vaccine programs.

Similar to the VFC program, immediate actions and follow-up activities were integrated into the site visit protocol to ensure compliance concerns were promptly addressed. This approach also supported the standardization of corrective actions across immunization programs. Furthermore, the reinforcement of provider education through the review of CDC requirements and recommendations during all site visits—irrespective of compliance status—fostered long-term compliance by equipping providers with the tools necessary to safely administer viable vaccines beyond the immediate post-visit period. Continued utilization of similar resources will be critical to the achievement of long-term compliance and the successful implementation of future vaccination programs.

Frequent changes in COVID-19 vaccine recommendations, including by age group, vaccine history, immunocompromised status, and new vaccine formulation approvals introduced additional complexity and challenges to adhering to CVPO program compliance requirements. Nonetheless, participating healthcare providers demonstrated generally high program compliance for vaccine administration processes (94.8 %), use of correct vials (97.5 %) and dose intervals (92.1 %), and reporting vaccine administration errors (96.4 %). Further, compliance across these areas remained consistent throughout the length of the CVPO program, irrespective of changes to vaccine recommendations or formulations. Although responsible for managing competing immunization priorities and navigating pandemic-related healthcare service disruptions, awardee oversight helped to ensure the continued viability and safety of COVID-19 vaccine products administered at these provider sites. As such, continued coordination between awardees and healthcare providers was essential in sustaining the high implementation of CVPO program safety requirements and ensuring the safe administration of the COVID-19 vaccine.

Prior to the commercialization of COVID-19 vaccines into the traditional healthcare market, pharmacies interested in administering the COVID-19 vaccine could enroll in the awardee-managed CVPO program, the Federal Retail Pharmacy Program (FRPP), or dually enroll in both. The FRPP was a collaborative initiative involving federal and state public health agencies, 21 national pharmacy partners, and independent pharmacy networks, with the aim of increasing access to COVID-19 vaccination [14]. In the present study, independent and chain pharmacy providers enrolled in the CVPO program demonstrated moderate overall compliance (57.9 % and 66.9 %, respectively); similar non-compliance as compared to other healthcare provider types was also observed for storage and handling and reporting (Table 2). Pharmacies enrolled by awardees were required to participate in COVID-19 vaccine site visits upon request; however, there was no similar requirement for pharmacies only receiving vaccines as part of the FRPP. Although such pharmacies may have internal processes to assess their vaccine management practices, these were not evaluated in this study. Research suggests pharmacy involvement as immunizers significantly increases vaccine uptake [15]; however, additional efforts may be required to better understand approaches needed to evaluate vaccine storage, handling, and administration practices in pharmacies outside of those directly receiving vaccine from awardees.

This study has several limitations. First, awardees were not required to conduct site visits with all enrolled CVPO program providers; therefore, site visit data may not be representative of all COVID-19 vaccination providers. Next, the completion status for each data collection form was self-selected by awardee-appointed site reviewers; no formal validation of submitted site visit data was performed. The authors were unable to determine whether an incomplete “Future Follow-up Checklist” instrument reflected site visit reviewer non-compliance or if no follow-up actions were necessary. Therefore, site visits that did not identify compliance issues may have been excluded, leading to lower observed compliance scores. The CVPO program site visit data dashboard was created to support programmatic activities; additional data recoding efforts were necessary to prepare data for use in research. Updates to the REDCap database were resource intensive which caused delays in aligning database content with new CDC and/or ACIP recommendations and/or the addition of new vaccine formulations. Although the authors were unable to associate observed negative changes in provider compliance with CVPO program changes, compliance remained relatively constant over the length of the program. Finally, some jurisdictions elected to complete more CVPO program site visits than others which may have affected the direction of overall findings. The proportion of site visits conducted relative to enrolled providers ranged from 7.9 % (Region 6) to 37.2 % (Region 10) across HHS regions; however, this study did not account for the fact that certain jurisdictions enrolled a greater number of providers into the CDC COVID-19 Vaccination Program than others. Furthermore, proportions were calculated using point-in-time data for enrolled providers as of the study mid-point, which may not have been fully representative of all providers with inventory and actively vaccinating throughout the study period.

This report presents an overview of healthcare provider adherence to COVID-19 Vaccination Provider Oversight program compliance requirements, including CDC and/or vaccine manufacturer recommendations. The high number and variety of healthcare providers participating in CDC’s CVPO program demonstrate both the interest and capacity of vaccination providers to participate in nationwide efforts to vaccinate both adult and pediatric populations. Further, high healthcare provider compliance, coupled with thorough follow-up efforts by awardees to address any non-compliance concerns, highlights the success of jurisdictions supporting healthcare providers with proper vaccine management (e.g., vaccine storage and handling), administration, and safety procedures. Additional research—including investigating factors contributing to statistically relevant variations in compliance among different provider types—can further strengthen vaccine storage, handling, and administration support to ensure effective and safe vaccination and to maintain vaccine confidence. Lessons learned from this program will be important for future vaccine response activities and for building a broader U.S. Government routine vaccine program for adults.