Supporting National Immunization Technical Advisory Groups (NITAGs) in development of evidence-based vaccine recommendations and NITAG assessments - New tools and approaches.

Increasing opportunities for prevention of infectious diseases by new, effective vaccines and the expansion of global immunization programs across the life course highlight the importance and value of evidence-informed decision-making (EIDM) by National Immunization Technical Advisory Groups (NITAGs). The U.S. Centers for Disease Control and Prevention (CDC) and Task Force for Global Health (TFGH) have developed and made available new tools to support NITAGs in EIDM. These include a toolkit for conducting facilitated training of NITAGs, Secretariats, or work groups on the use of the Evidence to Recommendations (EtR) approach to advise Ministries of Health (MoH) on specific vaccine policies, and an eLearning module on the EtR approach for NITAG members, Secretariat and others. The CDC and TFGH have also supported final development and implementation of the NITAG Maturity Assessment Tool (NMAT) for assessing maturity of NITAG capabilities in seven functional domains. The EtR toolkit and eLearning have been widely promoted in collaboration with the World Health Organization (WHO) Headquarters and Regional Offices through workshops engaging over 30 countries to date, and the NMAT assessment tool used in most countries in 3 WHO regions (Americas, Eastern Mediterranean, African). Important lessons have been learned regarding planning and conducting trainings for multiple countries and additional ways to support countries in applying the EtR approach to complete vaccine recommendations. Priorities for future work include the need to evaluate the impact of EtR training and NMAT assessments, working with partners to expand and adapt these tools for wider use, synergizing with other approaches for NITAG strengthening, and developing the best approaches to empower NITAGs to use the EtR approach.

National decision-making for the introduction of new vaccines: A systematic review, 2010-2020.

BACKGROUND: Competing priorities make using a transparent and evidence-based approach important when deciding to recommend new vaccines. We conducted a literature review to document the processes and frameworks for national decision-making on new vaccine introductions and explored which key features have evolved since 2010. METHODS: We searched literature published on policymaking related to vaccine introduction from March 2010 to August 2020 in six databases. We screened articles for eligibility with the following exclusion criteria: non-human or hypothetical vaccines, the sole focus on economic evaluation or decision to adopt rather than policy decision-making. We employed nine broad categories of criteria from the 2012 review for categorization and abstracted data on the country, income level, vaccine, and other relevant criteria. RESULTS: Of the 3808 unique references screened, 116 met eligibility criteria and were classified as: a) framework of vaccine adoption decision-making (27), b) studies that analyse empirical data on or examples of vaccine adoption decision-making (45), c) theoretical and empirical articles that provide insights into the vaccine policymaking process (44 + 17 already included in the previous categories). Commonly reported criteria for decision-making were the burden of disease; vaccine efficacy/effectiveness, safety; impact on health and non-health outcomes; economic evaluation and cost-effectiveness of alternative interventions. Programmatic and acceptability aspects were not as often considered. Most (50; 82%) of the 61 articles describing the process of vaccine introduction policymaking highlighted the role of country, regional, or global evidence-informed recommendations and a robust national governance as enabling factors for vaccine adoption. CONCLUSIONS: The literature on vaccine adoption decision-making has expanded since 2010. We found that policymakers and expert advisory committee members (e.g., National Immunization Technical Advisory Group [NITAG]) increasingly value the interventions based on economic evaluations. The results of this review could guide discussions on evidence-informed immunization decision-making among country, sub-regional, and regional stakeholders.

Strengthening National Immunization Technical Advisory Groups in resource-limited settings: current and potential linkages with polio national certification committees.

BACKGROUND: Countries are transitioning assets and functions from polio eradication to integrated immunization and surveillance activities. We assessed the extent of linkages between and perceptions of National Immunization Technical Advisory Groups (NITAGs) and National Certification Committees (NCCs) for polio eradication to understand how linkages can be leveraged to improve efficiencies of these expert bodies. METHODS: During May 2017 to May 2018, we administered a 15-question survey to a NITAG chair or member and an NCC counterpart in all countries of the WHO Regions for Africa (AFR) and for the Eastern Mediterranean (EMR) that had both a NITAG and an NCC. Data were analysed using frequency distributions. RESULTS: Of countries with both a NITAG and an NCC (n = 44), the response rate was 92% (22/24) in AFR and 75% (15/20) in EMR. Some respondents reported being very familiar with the functions of the other technical bodies, 36% (8/22) for NITAG members and 38% (14/37) for NCC members. Over 85% (51/59) of respondents felt it was somewhat useful or very useful to strengthen ties between bodies. Nearly all respondents (98%, 58/59) felt that NCC expertise could inform measles and rubella elimination programmes. CONCLUSIONS: We observed a broad consensus that human resource assets of NCCs may serve an important technical role to support national immunization policy-making. At this stage of the polio eradication initiative, countries should consider how to integrate the technical expertise of NCC members to reinforce NITAGs and maintain the polio essential functions, beginning in countries that have been polio-free for several years.

Assessing immunization interventions in the Women, Infants, and Children (WIC) program.

BACKGROUND: Vaccination promotion strategies are recommended in Women, Infants, and Children (WIC) settings for eligible children at risk for under-immunization due to their low-income status. PURPOSE: To determine coverage levels of WIC and non-WIC participants and assess effectiveness of immunization intervention strategies. METHODS: The 2007-2011 National Immunization Surveys were used to analyze vaccination histories and WIC participation among children aged 24-35 months. Grantee data on immunization activities in WIC settings were collected from the 2010 WIC Linkage Annual Report Survey. Coverage by WIC eligibility and participation status and grantee-specific coverage by intervention strategy were determined at 24 months for select antigens. Data were collected 2007-2011 and analyzed in 2013. RESULTS: Of 13,183 age-eligible children, 5,699 (61%, weighted) had participated in WIC, of which 3,404 (62%, weighted) were current participants. In 2011, differences in four or more doses of the diphtheria, tetanus toxoid, and acellular pertussis (DTaP) vaccine by WIC participation status were observed: 86% (ineligible); 84% (current); 77% (previous); and 69% (never-eligible). Children in WIC exposed to an immunization intervention strategy had higher coverage levels than WIC-eligible children who never participated, with differences as great as 15% (DTaP). CONCLUSIONS: Children who never participated in WIC, but were eligible, had the lowest vaccination coverage. Current WIC participants had vaccination coverage comparable to more affluent children, and higher coverage than previous WIC participants.

Are standing order programs associated with influenza vaccination? - NNHS, 2004.

BACKGROUND: Influenza vaccination coverage among nursing home residents has consistently been reported well below the Healthy People goals. We sought to determine if standing order programs (SOPs) in long-term care facilities are associated with greater influenza vaccination coverage among residents. METHODS: The National Nursing Home Survey (2004) is cross-sectional. A total of 1152 US long-term care facilities were systematically sampled with probability proportional to number of beds. A total of 11,939 people aged 65 years or older residing in sampled long-term care facilities between August and December 2004 were randomly sampled. Influenza vaccination coverage of residents was obtained from facility records. Facility's immunization program included standing orders versus other (preprinted admission order, advance physician order, personal physician order, and no program). Multinomial logistic regression was used to examine the relationship between type of influenza immunization program and receipt of vaccination, adjusted for resident and facility confounders. RESULTS: The proportion of residents aged 65 years or older who received influenza vaccination was 64%; 41% of residents lived in a facility with an SOP. Influenza vaccination coverage among residents residing in facilities with standing orders was 68% compared with 59% to 63% of residents in facilities with other program types. Logistic regression showed that standing order programs were independently associated with greater influenza vaccination coverage (66.7% versus 62.0%, P < .01). CONCLUSION: This study indicates that residents in long-term care facilities having standing order programs for influenza were more likely to be immunized. More research needs to be done to understand how to facilitate adoption of these programs.

Factors associated with antimicrobial use in nursing homes: a multilevel model.

OBJECTIVES: To describe antimicrobial prescribing patterns in nursing homes. DESIGN: Retrospective, observational study. SETTING: Total of 73 nursing homes in four U.S. states; study period was from September 1, 2001, through February 28, 2002. PARTICIPANTS: Four thousand seven hundred eighty nursing home residents. MEASUREMENTS: Number and type of antimicrobials, indication for their use, and resident and facility factors associated with antimicrobial use in nursing homes. RESULTS: Of 4,780 residents, 2,017 (42%) received one or more antibiotic courses. Overall, residents received a mean of 4.8 courses/1,000 resident-days (mean facility range 0.4-23.5). In multivariable analysis, higher probability of nursing home discharge and of being categorized in the rehabilitation, extensive services, special care, or clinically complex Resource Utilization Groups were associated with higher rates of antimicrobial usage. Three drug classes accounted for nearly 60% of antimicrobial courses-fluoroquinolones (38%), first-generation cephalosporins (11%), and macrolides (10%). The most common conditions for which antimicrobials were prescribed were respiratory tract (33%) and urinary tract (32%) infections. CONCLUSION: Antibiotic use is variable in nursing homes. Targeting educational and other antimicrobial use interventions to the treatment of certain clinical diagnoses and conditions may be an appropriate strategy for optimizing antimicrobial use in this setting.

Managed care organizations' performance in delivery of adolescent immunizations, HEDIS, 1999-2002.

PURPOSE: The Health Plan Employer Data Information Set (HEDIS) provides comparative information across health plans to measure the quality of care and preventive services for health plan beneficiaries. We examined recent trends in adolescent immunizations recommended by the Advisory Committee for Immunization Practices (ACIP) measured through HEDIS and reported to the National Committee for Quality Assurance (NCQA). METHODS: The study was based on a longitudinal regression analysis of commercial managed care organizations' HEDIS measures from 1999-2002. HEDIS performance measures and plan characteristics include a sample of approximately 100-400 enrollees per plan each year. The outcome measures were the proportions of enrollees aged 13 years sampled in the plan who received measles-mumps-rubella vaccine (MMR), hepatitis B vaccine, and varicella vaccine. RESULTS: The immunization rates for all three antigens increased significantly from 1999 to 2002 (MMR: 57-68%; hepatitis B: 28-51%; and varicella: 21-38%). Factors in the final multivariable models that were found to be significantly associated with increased proportions immunized with MMR vaccine, hepatitis B vaccine, and varicella vaccine include year of report, presence of school entry laws, years in business up to 25 years, and operating in the northeastern U.S. region; the only factor associated with decreasing immunization rates for all antigens was the number of providers per 100 commercial enrollees. CONCLUSIONS: Consistent with previous reports, adolescent immunization rates are improving yet remain suboptimal. Strategies to increase immunization rates, as well as to improve documentation of immunization status, among commercial health insurance plans need to be developed and implemented.

Assessing state immunization requirements for healthcare workers and patients.

BACKGROUND: Laws requiring vaccination for school entry have resulted in high coverage and reduced disease incidence; however, few data exist on the use of similar laws in other settings. This study reviews laws regulating vaccination of healthcare workers (HCWs) and patients in selected healthcare delivery settings. METHODS: From September 2004 to June 2005, Lexis-Nexis and other web-based databases were searched for laws pertaining to HCW and patient vaccination in 50 states and Washington DC. Laws were grouped by population, setting, vaccine type, and voluntary versus mandatory vaccination. Data were analyzed in 2006. RESULTS: Over half of states (n=32) have laws for HCW vaccination in traditional healthcare settings (hospitals, ambulatory care), while only seven states have laws for patients in these settings. Most laws regulating vaccine administration for HCWs were voluntary; requirements for mandatory immunization were most common for institutionalized populations. CONCLUSIONS: Significant state-to-state variation exists in laws for vaccination of HCWs and patients. Additional data are needed on how such vaccination requirements affect coverage in these populations. Model legislation may be helpful to states wishing to implement immunization requirements.

A status report from 1996-2004: are more effective immunization interventions being used in the women, infants, and children (WIC) program?

BACKGROUND: The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) enrolls almost 50% of the US birth cohort and these children have significantly lower immunization coverage rates than their counterparts not eligible for WIC. In 1994, the Centers for Disease Control and Prevention (CDC) and USDA began a national initiative to increase immunization coverage in low-income children by incorporating immunization-promoting activities into WIC visits (WIC/Immunization linkages). Since 1998, CDC has monitored the WIC/Immunization linkages assessment and referral (with and without the more aggressive strategy of monthly voucher pick-up, client outreach and tracking and parental incentives) and three other immunization supporting activities (computerized systems to assess immunization status, collocation of WIC and immunization services, coordination of WIC and immunization services). METHODS: Through an annual survey of state Immunization and WIC programs, a trend analysis was conducted for years 1998 through 2004 to determine changes in the use and frequency of WIC/Immunization linkage activities. RESULTS: During the 7-year study period, the use of assessment and referral increased from 71% to 94%, monthly voucher pick-up from 24% to 35%, and coordination of WIC and immunization services from 61% to 78% (p<0.0001 for all comparisons) in WIC sites nationwide. The frequency of assessment and referral (at each visit [four or more times/ year] versus certification visits [two times/year]) was reported to decrease during the study period (p<0.0001). Outreach and tracking and collocation of services did not change significantly while the use of parental incentives decreased (p<0.0001). The availability of computers and their use immunization assessment increased during the period. From 2002-2004, the number of states reporting that they base assessment and referral on a single vaccine (diphtheria-tetanus-acellular pertussis) instead of counting multiple vaccines increased from 5 to 10. CONCLUSIONS: Immunization promoting activities, especially those known to be most effective in improving coverage such as monthly voucher pickup, are increasing in WIC. Focusing on effective interventions including supporting activities such as computerized assessment will be essential in meeting Healthy People 2010 infant and childhood immunization coverage goals. In addition, the use of WIC resources can be minimized by encouraging evaluation of diphtheria-tetanus-acellular pertussis coverage as a marker for up to date status, instead of counting all vaccine doses.

Why do not patients receive influenza vaccine in December and January?

BACKGROUND: Influenza vaccination levels in older patients have changed little since the mid-1990s. Despite frequent health care visits by a majority of older persons, many missed opportunities continue to occur. METHODS: Patients were eligible for the study if they were age 50 and older, had not received influenza vaccine during the current season and were making a scheduled visit to one of the 13 study sites in California, New York, or New Mexico for purposes other than vaccination. Through direct observation, we determined if office staff inquired about vaccination status, discussed vaccination, or both. We defined missed opportunities as failure to administer influenza vaccine to patients for whom it was indicated. RESULTS: Missed opportunities increased steadily from October to January (P < 0.0001), and were more common when there was no inquiry or discussion (P < 0.00001), among patients aged 50-64 (P < 0.0001) and in California and New Mexico (P = 0.001). A classification tree analysis revealed that lack of inquiry and week of visit contributed most to missed opportunities. DISCUSSION: Early in the vaccination season, missed opportunities were uncommon and specific inquiries into or discussion of vaccination did not appear necessary. In December and January, patients tended to be vaccinated only when vaccination was addressed during the visit. Efforts to remind patients about vaccination later in the vaccination season may be essential to achieving higher coverage in the U.S.

Immunization coverage among Hispanic ancestry, 2003 National Immunization Survey.

BACKGROUND: The Hispanic population is increasing and heterogeneous (Hispanic refers to persons of Spanish, Hispanic, or Latino descent). The objective was to examine immunization rates among Hispanic ancestry for the 4:3:1:3:3 series (> or = 4 doses diphtheria, tetanus toxoids, and pertussis vaccine; > or = 3 doses poliovirus vaccine; > or = 1 doses measles-containing vaccine; > or = 3 doses Haemophilus influenzae type b vaccine; and > or = 3 doses hepatitis B vaccine). METHODS: The National Immunization Survey measures immunization coverage among 19- to 35-month-old U.S. children. Coverage was compared from combined 2001-2003 data among Hispanics and non-Hispanic whites using t-tests, and among Hispanic ancestry using a chi-square test. Hispanics were categorized as Mexican, Mexican American, Central American, South American, Puerto Rican, Cuban, Spanish Caribbean (primarily Dominican Republic), other, and multiple ancestry. RESULTS: Children of Hispanic ancestry increased from 21% in 1999 to 25% in 2003. These Hispanic children were less well immunized than non-Hispanic whites (77.0%, +/-2.1% [95% confidence interval] compared to 82.5%, +/-1.1% (95% CI) > in 2003). Immunization coverage did not vary significantly among Hispanics of varying ancestries (p=0.26); however, there was substantial geographic variability. In some areas, immunization coverage among Hispanics was significantly higher than non-Hispanic whites. CONCLUSIONS: Hispanic children were less well immunized than non-Hispanic whites; however, coverage varied notably by geographic area. Although a chi-square test found no significant differences in coverage among Hispanic ancestries, the range of coverage, 79.2%, +/-5.1% for Cuban Americans to 72.1%, +/-2.4% for Mexican descent, may suggest a need for improved and more localized monitoring among Hispanic communities.

Factors associated with underimmunization at 3 months of age in four medically underserved areas.

OBJECTIVE: Risk factors for underimmunization at 3 months of age are not well described. This study examines coverage rates and factors associated with under-immunization at 3 months of age in four medically underserved areas. METHODS: During 1997-1998, cross-sectional household surveys using a two-stage cluster sample design were conducted in four federally designated Health Professional Shortage Areas. Respondents were parents or caregivers of children ages 12-35 months: 847 from northern Manhattan, 843 from Detroit, 771 from San Diego, and 1,091 from rural Colorado. A child was considered up-to-date (UTD) with vaccinations at 3 months of age if documentation of receipt of diphtheria-tetanus-pertussis, polio, haemophilus influenzae type B, and hepatitis B vaccines was obtained from a provider or a hand-held vaccination card, or both. RESULTS: Household response rates ranged from 79% to 88% across sites. Vaccination coverage levels at 3 months of age varied across sites: 82.4% in northern Manhattan, 70.5% in Detroit, 82.3% in San Diego, and 75.8% in rural Colorado. Among children who were not UTD, the majority (65.7% to 71.5% per site) had missed vaccines due to missed opportunities. Factors associated with not being UTD varied by site and included having public or no insurance, >/=2 children living in the household, and the adult respondent being unmarried. At all sites, vaccination coverage among WIC enrollees was higher than coverage among children eligible for but not enrolled in WIC, but the association between UTD status and WIC enrollment was statistically significant for only one site and marginally significant for two other sites. CONCLUSIONS: Missed opportunities were a significant barrier to vaccinations, even at this early age. Practice-based strategies to reduce missed opportunities and prenatal WIC enrollment should be focused especially toward those at highest risk of underimmunization.

Operational conditions affecting the vaccination of older adults.

BACKGROUND: The content and context of the process of vaccinating older adults against influenza in outpatient settings has not been adequately described. Failure to appreciate the causal antecedents or precursors to the act of provider recommendation may explain why so many efficacious interventions identified by the U.S. Task Force on Community Preventive Services fail to be routinely implemented and why influenza immunization rates have remained static over the past decade. METHODS: This study used critical path analysis from data collected during standardized workflow observations of patients more than 50 years of age from a convenience sample of 16 ambulatory care settings in San Diego, California; Rochester, New York; and Albuquerque, New Mexico. Observations were made from October 23, 2001 to January 31, 2002. RESULTS: In this study, 62% (151/243) of patients observed during scheduled extended visits received influenza vaccinations. When operational, temporal, and clinical factors are examined altogether through critical path analysis, a model of seven critical organizational support, temporal, and clinical activities emerges that is able to predict 93% of the immunizations. Variation from the model predicts 73% of the missed opportunities. CONCLUSIONS: Vaccination of adults should not be seen as simply an incremental activity added to the general health encounter. Assuring a high rate of vaccination requires adequate time and operational support. Provider-patient discussion is more productively viewed as the culmination of the immunization process, not the beginning. Finally, this study indicates the potential need to identify and compare processes of care associated with other specific preventive services.

Standards for adult immunization practices.

Since the Standards for Adult Immunization Practices were first published in 1990, healthcare researchers and providers have learned important lessons on how to better achieve and maintain high vaccination rates in adults. The success rate of childhood immunization far exceeds the success rate of adult immunization. Thus, information and practices that will produce higher success rates for adult vaccination are crucial, resulting in overall societal cost savings and substantial reductions in hospitalizations and deaths. The Standards, which were developed to encourage the best immunization practices, represent the collective efforts of more than 100 people from more than 60 organizations. The revised Standards are more comprehensive than the 1990 Standards and focus on the accessibility and availability of vaccines, proper assessment of patient vaccination status, opportunities for patient education, correct procedures for administering vaccines, implementation of strategies to improve vaccination rates, and partnerships with the community to reach target patient populations. The revised Standards are recommended for use by all healthcare professionals and all public and private sector organizations that provide immunizations for adults. All who are involved in adult immunization should strive to follow the Standards in order to create the same level of success achieved by childhood vaccination programs and to meet the Healthy People 2010 goals.

Counting the shots: a model for immunization screening and referral in nonmedical settings.

BACKGROUND: Clinics of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) have become important partners in efforts to improve vaccination coverage in low income children. However, the time required to assess all antigens in each child's vaccination record may exceed the capacity of many of these clinics. Seeking a solution, experts recommended assessing up-to-date (UTD) status only for the diphtheria-tetanus-acellular-pertussis (DTaP) vaccine and treating this as a proxy measure for all vaccines in the childhood schedule. Whether this single vaccine screening method represents an acceptable alternative to the traditional multiple-vaccine method as a basis for improving overall immunization coverage levels in this vulnerable population has not been demonstrated. OBJECTIVE: To evaluate the validity of the proposed simplified method for assessing immunization status in a nationally representative population of infants and children who had ever been enrolled in WIC before 35 months old. METHODS: This was a cross-sectional analysis of the 2000 National Immunization Survey representing children ages 3 to 24 months who had ever been enrolled in WIC. For the 6277 children in the study population, we compared personal records of completion status for DTaP with personal records of completion status for all immunizations appropriate for age in the combination 4:3:1:3 schedule to see which of the 2 (single vs multiple screening) methods would better predict the child's true (provider-reported) status for the 4:3:1:3 series. The main outcome measures were the comparative sensitivity, specificity, and overall test efficiency of the 2 methods in correctly identifying underimmunized WIC children. RESULTS: Completion status for DTaP was less sensitive than completion status for all vaccinations in correctly identifying truly underimmunized children (sensitivity = 70% and 77%, respectively). However, it was more specific in correctly identifying children who were truly UTD for age (specificity = 86% and 82%, respectively). The 2 methods were essentially identical with respect to overall test efficiency (82% and 81% for DTaP assessment and assessment of all vaccines, respectively). CONCLUSIONS: Given limited resources to do immunization screening and referral in nonmedical settings such as WIC, simplifying the process by using DTaP from the personal vaccination record as a proxy for the 4:3:1:3 series is a viable option. Loss in sensitivity may well be offset by gains in the capacity of WIC clinics to screen more children.

Linking WIC and immunization services to improve preventive health care among low-income children in WIC.

Children participating in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) are at risk for low immunization coverage and other adverse health-related outcomes. Immunization-promoting strategies in WIC have been shown to produce dramatic improvements in immunization coverage. This evaluation of a local WIC initiative in Milwaukee is the first study to evaluate the impact of these strategies on improving the utilization of other clinical preventive services at the medical home. The use of more intensive immunization-promoting strategies in WIC may improve utilization of well child care visits and receipt of other clinical preventive services in the medical home.

Emerging issues in vaccine economics: perspectives from the USA.

Economic studies of vaccines, including vaccine development and delivery issues, are increasingly needed to inform policy recommendations and programmatic decisions in the USA. This need arises from the increasing costs of vaccines, the complexity of the US healthcare system and the limited number of vaccine manufacturers in the market. We have developed a national research agenda in domestic and global vaccine economics by conducting key informant interviews with 42 experts and inviting ideas from an additional 128 experts. To assess priorities among the 129 ideas that were generated, we asked 15 experts representing a broad range of perspectives to rank the ideas and we analyzed their votes. The highest-ranking domestic research ideas included evaluating: the costs of vaccine shortages, the cost-effectiveness of potential human papillomavirus vaccination and adult and adolescent pertussis vaccination programs and the cost-effectiveness of universal vaccine purchase programs for adults as well as children. The highest-ranking globally-oriented ideas included developing a resource allocation model to support the best vaccination program decisions with limited funds and assessing the cost-effectiveness of HIV, rotavirus, meningococcal and malaria vaccines in developing countries. To optimize the usefulness of vaccine economics research, conceptual issues, such as how to set values for the prevention of illness and how to maximize social equity through investments in vaccines, must be addressed.