Analysis of the Federal Section 317 Immunization Program and Routine Adult Immunization Activities, United States, 2022-2023

Abstract

Objectives:

The federal Section 317 Immunization Program, administered by the Centers for Disease Control and Prevention (CDC), provides funding to support adult immunization efforts; however, current information on program implementation at the jurisdictional level is limited. We assessed the use of Section 317 and other funding sources to support routine adult immunization activities among the 64 immunization programs (“awardees”).

Methods:

We conducted a survey and key informant interviews with awardees in October to December 2022 to collect quantitative and qualitative data on current adult vaccine purchase and program operation activities funded by Section 317 and other funding sources. We assessed total vaccine cost and data on vaccine purchase projections for each awardee with CDC’s Cost and Affordability Tool for 2023.

Results:

Immunization program managers or their designees from 62 of 64 awardees (97%) completed the survey; 12 awardees participated in key informant interviews. Of 62 awardees, 32 (52%) used a single funding source to support adult vaccine purchases, of which 29 (91%) used only Section 317 funds, 21 (34%) reported not planning to purchase ≥1 age-based recommended vaccine for adults in 2023, and 33 (53%) reported using Section 317 funds only to support adult immunization program operations. Key informant interviews showed varied operational activities among awardees, but 8 awardees stated the need for additional staff to expand adult immunization program services in health care provider education (n = 5), program administration (n = 5), and site visits (n = 6).

Conclusions:

Additional efforts are needed to understand how to better support routine adult immunization activities implemented at the jurisdictional level.

Adult vaccination coverage in the United States is low for all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP), with approximately 20% of adults aged ≥19 years having received all recommended vaccines. ¹ Furthermore, adults without health insurance (uninsured) are significantly less likely to be vaccinated than adults with health insurance ² ; in 2020, 13.9% of working-age adults in the United States were uninsured. ³ Although no federal entitlement program exists to support the immunization of adults who are uninsured and underinsured (ie, a person who has health insurance but coverage does not include all or some vaccines), vaccines for adults can be purchased through the federal Section 317 Immunization Program (hereinafter, Section 317). ⁴

Enacted in 1962 through Section 317 of the Public Health Service Act, Section 317 includes grants to all 50 states, 6 cities, 5 US territories, and 3 freely associated states (“awardees”). ⁵ Section 317 funds national, state, and local immunization programs, including public health workforce, information technology infrastructure, laboratory capacity, and education and communication campaigns. Section 317 funds also support the Centers for Disease Control and Prevention’s (CDC’s) capacity to respond to disease outbreaks, such as by providing technical support for vaccine-preventable disease investigations and conducting tests in support of these investigations.^4,6 In addition, Section 317 funds CDC scientific studies about the burden of disease and vaccine effectiveness, which provide the basis for national immunization recommendations and programs. ⁶ Finally, Section 317 funds are used to address disparities in national vaccination coverage through vaccine purchase and discretionary funds for immunization program operations. ⁷

Although Section 317 has been historically used to support pediatric vaccination, ⁸ the policies on patient eligibility in Section 317 were modified after passage of the Affordable Care Act, ⁹ which required all private health insurance plans to cover routine childhood vaccines. The Vaccines for Children (VFC) entitlement program further ensures vaccine access for uninsured children. ¹⁰ As such, people who are eligible to receive Section 317–purchased vaccines include (1) uninsured adults, (2) underinsured adults, (3) people with health insurance who are seeking vaccines during a public health response, (4) people who are incarcerated, and (5) American Indian or Alaska Native people whose only health care is provided by an Indian Health Service, Tribal, or Urban health care organization. CDC develops the policy on which patients are eligible to receive vaccines purchased with Section 317 funds; however, awardees have broad discretion in how to use Section 317 funds or other funds to operationalize their immunization efforts.

We assessed the use of Section 317 funds and other funds to support adult vaccine purchases and implementation of adult immunization program operations among the 64 CDC-funded immunization programs at the jurisdictional level.

Methods

We used 3 sources of data for this study: survey, key informant interviews, and CDC’s Cost and Affordability Tool (CAT). ¹¹ CDC determined this study to be research not involving human participants (per 45 CFR part 46; 21 CFR part 56; 42 USC §241[d]; 5 USC §552a; 44 USC §3501 et seq) and, therefore, did not seek institutional review board approval.

Survey Design and Administration

CDC’s Immunization Services Division developed a survey to assess current Section 317 adult vaccine eligibility and prioritization strategies as well as routine adult immunization program funding sources, activities, and operations. We validated the survey by using a series of working groups composed of immunization program managers and external subject matter experts. We disseminated the final survey via REDCap (Research Electronic Data Capture)^12,13 to all 64 awardees by using contact information from the Association of Immunization Program Managers online directory ¹⁴ and contact information collected by CDC. We asked immunization program managers or their designees to respond to the survey. We sent awardees that did not respond up to 3 automated REDCap-generated email reminders. We surveyed awardees from October 26 through November 23, 2022.

Administration of Key Informant Interviews

We used key informant interviews to collect additional contextual program information related to the survey topics (ie, Section 317 patient eligibility, Section 317 vaccine prioritization, adult immunization program activities). The Immunization Services Division developed a key informant interview discussion guide with input from an external panel of subject matter experts.

We selected key informants using a 3-step process. First, we solicited interest to participate in a key informant interview. Next, we scored survey responses from all interested awardees by using the following response categories: (1) implementation of adult immunization activities, (2) nonimplementation of adult immunization activities, and (3) number of active adult vaccine provider types and/or organizations participating in the adult vaccine program (eg, family practice, internal medicine, specialty care providers, federally qualified health centers, rural health centers, health departments, pharmacies). We then summed the counts for each response category and assigned an intermediary rank score ranging from 1 (low cumulative score) through 5 (high cumulative score). We calculated the ranges for each rank level by dividing the total number of available options for each category by 5. We used the intermediary rank scores to calculate the average score across all categories for each interested awardee to compute an overall rank score.

Finally, we compared overall rank scores among awardees within each of the 10 US Department of Health and Human Services regions. We selected 12 awardees representing a range of both high-rank and low-rank scores across the 10 regions to participate in key informant interviews. We followed previous research on semistructured interviewing, which stated that saturation can be achieved after 12 interviews, particularly when the sample is relatively homogenous. ¹⁵

We included up to 5 representatives from each selected awardee to participate in the virtual key informant interview. We conducted 1 key informant interview with each selected awardee and included all designated representatives for that program; representatives included immunization program managers, adult immunization coordinators, and other relevant program staff. We conducted key informant interviews from December 1 through December 16, 2022.

CDC CAT

Awardees submit projections for routine adult vaccine purchases by using the CDC CAT, which summarizes data by vaccine type and funding source. ¹¹ CDC requires awardees to submit CAT data annually to validate each program’s vaccine finance policy, including vaccine purchase projections for pediatric, adolescent, and adult populations (Immunization Program Operations Manual, National Center for Immunization and Respiratory Diseases, January 2023, unpublished). ¹⁶ We used CAT data current as of March 2023.

Analysis

We used SAS version 9.4 (SAS Institute Inc) to calculate descriptive statistics for survey findings and CAT data. To evaluate findings from key informant interviews, we applied thematic content analysis. ¹⁶ We manually reviewed content from key informant interview transcripts and organized findings into an analytic matrix to identify response patterns for cross-awardee comparison. We quantified data by topic and identified subthemes by using analytical review.

Results

Of the 64 CDC-funded immunization program awardees, 62 (97%) responded to the survey.

Adult Vaccine Purchases

Of 62 awardees that responded to the survey, 32 (52%) reported using a single source of funds to purchase adult vaccines (29 [91%] used only Section 317 funds, 2 [6%] used only state and local funds, and 1 [3%] used only local funds). Twenty-five of 62 awardees (40%) used a combination of Section 317 funds and state, local, and/or city funds, and 5 awardees (8%) (Alaska, Arkansas, Mississippi, Rhode Island, and Vermont) supplemented their combined funding sources with health insurer funds (eg, state-assessed fees from health insurance organizations operating within their jurisdiction) (Figure 1).

Figure 1.

Types of funding sources used to purchase Advisory Committee on Immunization Practices–recommended adult vaccines, according to a survey of federal Section 317 Immunization Program awardees, October 26 through November 23, 2022. Data are presented for 62 of 64 awardees (San Antonio, Texas, and the Marshall Islands did not participate in the survey). Funding options included state (S), local (L), or city (C) funds; Section 317 vaccine funds; state-levied fees from vaccine manufacturers; funds from health insurance (eg, health insurer fees); and external funds. Funding efforts limited to COVID-19 pandemic response efforts are not shown. Federal funding indicates the use of only Section 317 Immunization Program discretionary funds to purchase routine adult vaccines. Other indicates awardees that used the following funding combinations for adult vaccine purchase: state funds and health insurer fees (Mississippi); federal funds and health insurer fees (Vermont); federal funds, state funds, and health insurer fees (Arkansas and Rhode Island); and federal funds, state and local funds, health insurer fees, and state-levied fees (Alaska).

Annually collected CAT data for 2023 showed that awardees planned to use Section 317 funds as their primary funding source (either as the sole funding source or in combination with state funds) to purchase routine adult vaccines, regardless of vaccine type (Figure 2). Five awardees reported using only state funds to purchase adult vaccines. Many awardees planned to use Section 317 funds to purchase the following vaccines recommended for all age-appropriate adults: influenza (n = 36 of 62; 58%); tetanus, diphtheria, and acellular pertussis (Tdap) (n = 36 of 62; 58%); and hepatitis B (n = 37 of 62; 60%) vaccines. Of 62 awardees, 21 (34%) planned not to purchase any doses of zoster vaccine, regardless of funding source, and 34 (55%) planned to use Section 317 funds to purchase vaccines for people aged ≤18 years. Of 34 awardees, 11 (32%) planned to use <50% of their Section 317 vaccine allocation for adult vaccines and 4 (12%) planned to use >90% of their Section 317 vaccine allocation to purchase pediatric vaccines.

Figure 2.

Planned purchases of Advisory Committee on Immunization Practices–recommended vaccines among federal Section 317 Immunization Program awardees, by funding source, as self-reported by awardees using the Cost and Affordability Tool (CAT), March 10, 2023. Vaccines purchased with health insurance fees are not shown because this option is not included in CAT. ¹¹ Vaccines with age-based recommendations include influenza (flu); pneumococcal conjugate vaccine (PCV13); tetanus, diphtheria, and acellular pertussis (TDAP); hepatitis B virus (HEPB); and zoster virus (ZOS). Vaccines may be recommended and/or available based on health condition, travel requirements, and occupational needs; response to an outbreak of vaccine-preventable diseases; and public health preparedness exercise.

Abbreviations: HEPA, hepatitis A virus; HPV, human papillomavirus; MCV4, meningococcal quadrivalent; MENB, meningococcal B; MMR, measles, mumps, and rubella; PPSV23, pneumococcal conjugate polysaccharide vaccine; VAR, varicella.

Of 62 awardees, 42 (68%) reported that they used the same patient eligibility criteria for vaccines purchased with state or local funds as patient eligibility criteria for vaccines purchased using Section 317 funds. However, 20 awardees (32%) expanded patient eligibility policies for vaccine purchases made with state or local funds to include people with health insurance (n = 13; 65%), immigrant and refugee populations (n = 11; 55%), people with undocumented status (n = 10; 50%), people living in congregate settings (n = 9; 45%), people with health insurance that has a high deductible and/or cost-sharing plan (n = 8; 40%), and migrant farm workers (n = 7; 35%), which are groups not currently eligible for Section 317 vaccines.

Routine Adult Immunization Program Operations

Thirty-three awardees (53%) used only federal funds (ie, Section 317, Prevention and Public Health Funds, other CDC program funds) to support their routine adult immunization program operations, and 24 awardees (39%) supplemented federal funds with state, local, and/or city funds (Figure 3). Two awardees (3%), from Mississippi and the US Virgin Islands, reported using only state, local, and/or city funds to support the implementation of routine adult immunization activities. Awardees from Alaska, South Carolina, and Vermont reported supplementing federal, state, local, and/or city funds with support from the private sector.

Figure 3.

Support for routine adult immunization program operations by funding source according to a survey of federal Section 317 Immunization Program awardees, October 26 through November 23, 2022. Data are presented for 62 of 64 awardees (San Antonio, Texas, and the Marshall Islands did not participate in the survey). Funding options included state (S), local (L), or city (C) funds or Section 317 operation funds, public health funds, private sector funds, and other program funds from the Centers for Disease Control and Prevention (CDC). Funding efforts limited to COVID-19 pandemic response efforts are not shown. Federal funding indicates the use of Section 317 operation, public health, and/or other CDC program funds to support routine adult immunization program operations. Other indicates awardees that used the following funding combinations to support adult immunization program operations: federal and private sector funds (Alaska, Vermont) or federal, state, and private sector funds (South Carolina).

Among 62 awardees, 50 (81%) reported implementing activities to monitor adult vaccine provider progress and/or to increase adult vaccination coverage (Figure 4). Regardless of funding source, 24 awardees (39%) reported that they did not employ any full-time adult immunization program staff. Of 33 awardees (53%) that used federal funds only for adult immunization operations, 18 (55%) supported staffing of full-time adult immunization positions within their program, which was lower than shown among awardees that used additional state, local, and/or city funds (16 of 24; 67%) and awardees that used other funding combinations (4 of 5; 80%) to support staffing. For implementation of vaccine provider site visits, more awardees reported using additional state, local, and/or city funds (16 of 24; 67%) or other funding combinations (4 of 5; 80%) than using only federal funds (20 of 33; 61%). Fifty-three awardees (85%) requested additional guidance on operations (eg, site visits, quality improvement, health care provider enrollment) from CDC to support adult immunization activities.

Figure 4.

Number of federal Section 317 Immunization Program awardees that implemented routine adult immunization program activities, by funding source, according to survey responses, October 26 through November 23, 2022. Data are presented for 62 of 64 awardees (San Antonio, Texas, and the Marshall Islands did not participate in the survey). Federal funding indicates the use of Section 317 operations, public health funds, and/or other program funds from the Centers for Disease Control and Prevention to support operations for routine adult immunization programs. Other indicates awardees that used a combination of federal, private, and state (S), local (L), and city (C) funds (Alaska, South Carolina, Vermont) or that used only S/L/C funds to support operations of routine adult immunization programs (Mississippi, US Virgin Islands).

Key Informant Interviews on Section 317 and Adult Immunization Topics

Awardees’ interest varied in expanding the current policy criteria on patient eligibility under Section 317 to include additional adult populations (Table). Of 12 key informant interviews, 7 supported expanding eligibility to include people living in congregate settings (n = 3), adult beneficiaries of Medicaid/Medicare (n = 3), people who are effectively uninsured (ie, lack access to comprehensive primary care or have health insurance with high copays for vaccination) (n = 4), and people with undocumented immigration status (n = 6). However, all awardees interviewed stated that increased Section 317 program funds would be necessary to ensure no disruption of existing services to currently eligible adults before expansion of adult vaccine programs to other adult populations could be considered.

Table.

Themes by topic obtained after key informant interviews with awardees of the federal Section 317 Immunization Program, December 1 through 16, 2022 ^a

Topic	Themes explored	No. of key informants (N = 12)
Section 317 Immunization Program eligibility	• Limitations of current Section 317 patient eligibility policy to meet needs of additional adult populations experiencing vaccine disparities	4
	• Limitations of current vaccine funding levels to meet demand among eligible adult populations	5
	• Challenges on how to define “uninsured” and “underinsured” adults	6
	• Implications for changing the post-ACA Section 317 Immunization Program eligibility criteria	7
Section 317 vaccine prioritization strategies	• Variability in use of health care provider demand to inform vaccine ordering and purchases	5
	• Implementation of annual purchasing reserves for responses to outbreaks of vaccine-preventable disease	6
	• Use of program cost analysis for vaccine selection (eg, limited purchase of zoster vaccine due to cost)	6
	• Reliance on Section 317 funds to support routine adult vaccine purchases	8
	Implementation of health care provider type and site selection processes	9
Adult immunization program infrastructure	• Level of engagement with state legislature on adult immunization issues	5
	• Prevalence of sharing staff with VFC program	8
	• Need for additional staff to expand adult immunization activities	8
	• Benefits of having dedicated adult immunization funding sources	10
Health care provider oversight	• Need for quality improvement site visits for health care providers	5
	• Allow leveraging of existing site visits for VFC and/or COVID-19 vaccine providers to monitor Section 317 health care providers	7
	• Need for health care provider enrollment site visits	7
	• Need for health care provider compliance site visits	7
	• Need for vaccine storage and handling site visits	9
Adult vaccine and coverage monitoring	• Lack of jurisdiction-specific composite vaccination measures	3
	• Use of existing monitoring systems and processes	5
	• Issues with IIS data completeness	7
	• Use of vaccine inventory reporting standards	9
	• Improvements to IIS related to COVID-19 funding sources to increase adult vaccine dose recording in IIS	9

Abbreviations: ACA, Affordable Care Act; IIS, immunization information system; VFC, Vaccines for Children.

^aThe federal Section 317 Immunization Program, administered by the Centers for Disease Control and Prevention, provides funding to support adult immunization efforts. ⁴ Key informant interviews were conducted with immunization program managers, adult immunization coordinators, and other relevant program staff among 12 of 64 immunization program awardees from the following jurisdictions: California; Chicago, Illinois; Georgia; Houston, Texas; Kansas; Minnesota; Nevada; New York; North Dakota; Oregon; Pennsylvania; and Rhode Island.

Eight awardees stated that they used Section 317 funds to support routine adult vaccine purchases. All 12 awardees interviewed stated that the demand for adult vaccinations among eligible patients exceeded what the current Section 317 funds or any supplemental state, local, and/or city funds could support. To manage vaccine purchases with Section 317 funds, some awardees stated that they set ordering caps and allowed ordering by health care provider request or demand up to that cap (n = 5), conducted cost analysis based on historical ordering (n = 5), restricted purchases of high-cost vaccines (n = 2), or prioritized influenza vaccine ordering (n = 2).

Nine of 12 awardees stated that they fund their immunization program staff by using multiple funding sources. In addition, awardees stated that program staff often support implementation of both routine pediatric and adult immunization activities, including health care provider recruitment, enrollment, and monitoring to ensure compliance with program requirements. However, 8 awardees stated that additional staff was necessary to expand adult immunization program services to meet adult program goals, specifically in the areas of health care provider education (n = 5), program administration (n = 5), and site visits (n = 6). Ten awardees stated that having a dedicated line-item funding source for adult immunization operations in core budgets would justify the hiring of full-time adult immunization program employees versus using temporary staff.

Eight awardees stated that they conduct ≥1 site visit type (eg, health care provider enrollment, storage/handling, quality assurance, quality improvement) with health care providers enrolled in their adult immunization program; the awardees stated that they often completed site visits in combination with existing VFC and/or COVID-19 vaccination provider site visits, as health care providers are enrolled in multiple programs. Nine awardees stated that they conduct adult vaccine storage and handling site visits using the same approach and methods outlined for the VFC program. In general, procedures for and frequency of site visits conducted with health care providers were highly variable across all awardees interviewed.

Nine awardees indicated that they used their immunization information system (IIS) to monitor whether doses distributed to health care providers were administered to eligible beneficiaries (eg, vaccine labeling, doses administered, inventory reconciliation). Nine awardees described how supplementary COVID-19 response funds enhanced existing IISs to better support data exchange among states (n = 1), data reporting (n = 3), vaccine ordering, delivery, and tracking (n = 3), and improved interoperability (n = 4).

Discussion

In this study, we described the use of Section 317 funds and other funds to support adult vaccine purchases and implementation of adult immunization program operations among the 64 CDC-funded immunization programs at the jurisdictional level. Most awardees continued to rely on federal funds to support adult vaccine purchases and program operations. However, a large proportion of awardees supplemented federal funds with state, local, or city funds; other external funding sources were rare. Because awardees often use Section 317 funds to support other vaccine-related public health activities, many reported high variability in conducting health care provider site visits, monitoring program progress, and supporting health care education.

Congressionally appropriated funds for Section 317 increased from 2018 through 2023; however, allocations made to awardees to support the purchase of adult vaccines were relatively stable. In our study, awardees reported that the demand for ACIP-recommended adult vaccines exceeded current Section 317 or any supplemental state, local, and/or city funding levels. Furthermore, roughly one-third of awardees did not plan to purchase ≥1 age-based recommended vaccine for adults in 2023. The number of recommended adult vaccines has also steadily increased ¹⁷ ; the ACIP currently recommends 13 vaccines for people aged ≥19 years to protect against vaccine-preventable diseases across the life span. ¹⁸ In addition, vaccine prices have risen because of increasingly complicated manufacturing processes, disease targets, and vaccine formulations. ¹⁹ As such, vaccine purchase allocations have been unable to keep up with both increased vaccine demand and cost, leaving uninsured and underinsured adults at risk for vaccine-preventable diseases.

In a 2016 study that evaluated public health workforce needs and development, both state public health agencies and local public health departments reported critical staffing gaps across all departments, including among administrative, support, management, and leadership staff. ²⁰ Our study showed that most immunization programs reported having insufficient staff necessary to support routine adult immunization activities, including enrollment of new adult vaccine providers and conducting site visits to monitor health care provider compliance. In addition, only 61% of awardees currently employ dedicated adult immunization program staff to support management of overall strategic planning, implementation, and evaluation of adult immunization program efforts for their jurisdiction. Although anecdotal evidence suggests that hiring freezes, legislative barriers, and inadequate pay contributed to chronic understaffing, future research may better quantify and describe staffing barriers at the jurisdictional level (M. Banks, MS, oral communication, March 2023).

In addition to having limited funding sources for uninsured adults, state and local health departments have restricted capacity to collect data for monitoring routine adult vaccination coverage. As such, adult vaccination records are often incomplete because of a lack of health care provider reporting mandates and/or limited resources to enforce policies in which IIS reporting mandates are enacted. ²¹ Most awardees reported that supplementary COVID-19 vaccination funds enhanced the IIS infrastructure and facilitated health care provider reporting (partly because reporting was a requirement of the COVID-19 Vaccination Program ²² ). However, a recent review of the infrastructure and network of IISs for COVID-19 vaccination campaigns suggested that these changes are unsustainable and concluded that long-term financial investment is necessary to reduce health care provider reporting burden, expand staffing and infrastructure for immunization information technology, and facilitate public and health care provider access to accurate and complete data. ²³

The VFC program has substantially reduced vaccine coverage disparities among children through increased access to vaccines and elimination of cost barriers. ²⁴ Critical to the success of this program are the VFC requirements to conduct health care provider site visits, educate enrolled health care providers, and support quality improvement activities. In contrast, similar implementation and oversight requirements do not currently exist for Section 317. Standardizing the use of CDC-recommended site visits for monitoring and oversight of Section 317 health care providers may reduce the variability in site visit implementation observed in our study. In addition, competing requests for the use of Section 317 funds to respond to outbreaks of vaccine-preventable disease, vaccinate uninsured or underinsured children, and support perinatal hepatitis B vaccination programs further limit which ACIP-recommended vaccines are available for Section 317–eligible populations.

In 2022, the US Government Accountability Office (GAO) published a report describing current adult vaccination rates and state and federal efforts to improve access to vaccination. Although comprehensive, the assessment of state-level activities included only data compiled from a public domain review of immunization program websites and a small selection of interviews. ²⁵ The GAO report concluded that most immunization programs offer free routine adult vaccines to uninsured and/or underinsured adults, in part using Section 317 funds; these findings are substantiated in our study (66% vs 67%, respectively). Our study provides additional data, not reported in the GAO report, directly from state programs describing their adult program operational activities and challenges implementing these activities.

Limitations

This study had several limitations. First, our survey findings were self-reported by awardees and, thus, were subject to social desirability bias. Second, we conducted the survey and key informant interviews during the interim period between the passing of the Inflation Reduction Act and its full implementation, ²⁶ which eliminated cost sharing for Medicare Part D vaccines. ²⁷ As such, presented findings for selected activities associated with changes introduced by the Inflation Reduction Act may be out of date. Third, we did not collect data on the stability of supplemental state, local, and city funding sources; however, current findings can inform future research to better understand the potential effects of stable funding sources on various programs and initiatives.

Conclusions

Most immunization program awardees rely on Section 317 funds to support adult immunization efforts; however, expansion of the immunization schedule, rising costs of vaccines, and relatively fixed funding levels have resulted in awardees increasingly unable to meet the demand to provide ACIP-recommended adult vaccines.^28,29 Even in jurisdictions with supplemental funds available to support routine adult vaccination, implementation of operational activities and access to all ACIP-recommended adult vaccines varied. Additional programmatic and research efforts are necessary to understand how to better support routine adult immunization activities.