Cost-Effectiveness Analysis of Vaccination With Recombinant Zoster Vaccine Among Hematopoietic Cell Transplant Recipients and Persons With Other Immunocompromising Conditions Aged 19 to 49 Years.

OBJECTIVES: This study aimed to estimate the cost-effectiveness of the use of recombinant zoster vaccine (RZV) (Shingrix), which protects against herpes zoster (HZ), among immunocompromised adults aged 19 to 49 years, as a contribution to deliberations of the Advisory Committee on Immunization Practices. METHODS: Hematopoietic cell transplant (HCT) recipients experience a high incidence of HZ, and the efficacy of RZV in preventing HZ has been studied in clinical trials. The cost-effectiveness model calculated incremental cost-effectiveness ratios that compared vaccination with RZV with a no vaccination strategy among adults aged 19 to 49 years. Costs and outcomes were calculated until age 50 years using the healthcare sector perspective and summarized as cost per quality-adjusted life-year (QALY) gained. The base case represents HCT recipients, with scenario analyses representing persons with other immunocompromising conditions, including hematologic malignancies, human immunodeficiency virus, and autoimmune and inflammatory conditions. Uncertainty was investigated using univariate, multivariate, and probabilistic sensitivity analyses. RESULTS: Base-case results indicated vaccination with RZV would avert approximately 35% of HZ episodes and complications, while saving approximately 11% of net costs. Compared with no vaccination, vaccination of HCT recipients with RZV generated cost-savings (ie, lower costs and improved health) in the base case and in 81% of simulations in the probabilistic analysis. In scenario analyses, vaccination cost US dollar ($) 9500/QALY among patients with hematologic malignancies, $79 000/QALY among persons living with human immunodeficiency virus, and $208 000/QALY among persons with selected autoimmune and inflammatory conditions. CONCLUSIONS: Generally favorable economic estimates supported recommendations for vaccination of immunocompromised adults with RZV to prevent episodes of HZ and related complications.

Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2022.

Zoster Vaccine Recombinant, Adjuvanted (Shingrix, GlaxoSmithKline [GSK]) is a 2-dose (0.5 mL each) subunit vaccine containing recombinant glycoprotein E in combination with adjuvant (AS01B) that was licensed in the United States for prevention of herpes zoster for adults aged ≥50 years by the Food and Drug Administration (FDA) and recommended for immunocompetent adults aged ≥50 years by the Advisory Committee on Immunization Practices (ACIP) in 2017* (1). On July 23, 2021, the FDA expanded the indication for recombinant zoster vaccine (RZV) to include adults aged ≥18 years who are or will be at increased risk for herpes zoster because of immunodeficiency or immunosuppression caused by known disease or therapy (2). On October 20, 2021, ACIP recommended 2 doses of RZV for the prevention of herpes zoster and related complications in adults aged ≥19 years† who are or will be immunodeficient or immunosuppressed because of disease or therapy. RZV is the first herpes zoster vaccine approved for use in immunocompromised persons. With moderate to high vaccine efficacy and an acceptable safety profile, RZV has the potential to prevent considerable herpes zoster incidence and related complications. This report updates previous ACIP recommendations for the prevention of herpes zoster (1,3).

Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022.

In 2021, 20-valent pneumococcal conjugate vaccine (PCV) (PCV20) (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.) and 15-valent PCV (PCV15) (Merck Sharp & Dohme Corp.) were licensed by the Food and Drug Administration for adults aged ≥18 years, based on studies that compared antibody responses to PCV20 and PCV15 with those to 13-valent PCV (PCV13) (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.). Antibody responses to two additional serotypes included in PCV15 were compared to corresponding responses after PCV13 vaccination, and antibody responses to seven additional serotypes included in PCV20 were compared with those to the 23-valent pneumococcal polysaccharide vaccine (PPSV23) (Merck Sharp & Dohme Corp.). On October 20, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended use of either PCV20 alone or PCV15 in series with PPSV23 for all adults aged ≥65 years, and for adults aged 19-64 years with certain underlying medical conditions or other risk factors* who have not previously received a PCV or whose previous vaccination history is unknown. ACIP employed the Evidence to Recommendation (EtR) framework,† using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE)§ approach to guide its deliberations regarding use of these vaccines. Before this, PCV13 and PPSV23 were recommended for use for U.S. adults and the recommendations varied by age and risk groups. This was simplified in the new recommendations.

Use of 15-Valent Pneumococcal Conjugate Vaccine Among U.S. Children: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2022.

The 13-valent pneumococcal conjugate vaccine (PCV13 [Prevnar 13, Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer, Inc]) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23 [Merck Sharp & Dohme LLC]) have been recommended for U.S. children, and the recommendations vary by age group and risk group (1,2). In 2021, 15-valent pneumococcal conjugate vaccine (PCV15 [Vaxneuvance, Merck Sharp & Dohme LLC]) was licensed for use in adults aged ≥18 years (3). On June 17, 2022, the Food and Drug Administration (FDA) approved an expanded usage for PCV15 to include persons aged 6 weeks-17 years, based on studies that compared antibody responses to PCV15 with those to PCV13 (4). PCV15 contains serotypes 22F and 33F (in addition to the PCV13 serotypes) conjugated to CRM197 (genetically detoxified diphtheria toxin). On June 22, 2022, CDC's Advisory Committee on Immunization Practices (ACIP) recommended use of PCV15 as an option for pneumococcal conjugate vaccination of persons aged <19 years according to currently recommended PCV13 dosing and schedules (1,2). ACIP employed the Evidence to Recommendation (EtR) Framework,* using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE)† approach to guide its deliberations regarding use of these vaccines. Risk-based recommendations on use of PPSV23 for persons aged 2-18 years with certain underlying medical conditions§ that increase the risk for pneumococcal disease have not changed.

A review of health-related quality of life associated with pneumococcal disease: pooled estimates by age and type of disease.

BACKGROUND: Estimates in the research literature on the health-related quality of life (QOL) associated with pneumococcal disease exhibit variation. It complicates the selection of estimates in modeling projects that evaluate the health impact and economic value of the prevention and treatment. This study reviewed the literature and developed pooled QOL estimates associated with pneumococcal disease states. METHODS: We searched peer-reviewed literature for studies that reported pneumococcal disease-related QOL estimates. For each study, we extracted QOL estimates and categorized by age group and disease state. QOL estimates were converted to quality-adjusted life-years (QALYs). Pooled QALY estimates were calculated using simple average, sample-size weighting and inverse-variance weighting. RESULTS: From 18 studies, we organized QOL estimates into 20 groups based on age and disease state. We observed the largest within-disease state variations of QALY estimates in meningitis-related disease states compared to other disease states. Across all age-disease state categories, the pooled QALY estimates ranged from 0.39 for meningitis with long-term sequelae among 0- to 18-year-olds, to 1.00 for non-inpatient pneumonia among 0- to 18-year-olds. CONCLUSIONS: Our results indicated disparities in QOL estimates associated with pneumococcal disease from the literature. Pooled estimates provided a source of consistency that can be used in future modeling efforts.

Opening of Large Institutions of Higher Education and County-Level COVID-19 Incidence - United States, July 6-September 17, 2020.

During early August 2020, county-level incidence of coronavirus disease 2019 (COVID-19) generally decreased across the United States, compared with incidence earlier in the summer (1); however, among young adults aged 18-22 years, incidence increased (2). Increases in incidence among adults aged ≥60 years, who might be more susceptible to severe COVID-19-related illness, have followed increases in younger adults (aged 20-39 years) by an average of 8.7 days (3). Institutions of higher education (colleges and universities) have been identified as settings where incidence among young adults increased during August (4,5). Understanding the extent to which these settings have affected county-level COVID-19 incidence can inform ongoing college and university operations and future planning. To evaluate the effect of large colleges or universities and school instructional format* (remote or in-person) on COVID-19 incidence, start dates and instructional formats for the fall 2020 semester were identified for all not-for-profit large U.S. colleges and universities (≥20,000 total enrolled students). Among counties with large colleges and universities (university counties) included in the analysis, remote-instruction university counties (22) experienced a 17.9% decline in mean COVID-19 incidence during the 21 days before through 21 days after the start of classes (from 17.9 to 14.7 cases per 100,000), and in-person instruction university counties (79) experienced a 56.2% increase in COVID-19 incidence, from 15.3 to 23.9 cases per 100,000. Counties without large colleges and universities (nonuniversity counties) (3,009) experienced a 5.9% decline in COVID-19 incidence, from 15.3 to 14.4 cases per 100,000. Similar findings were observed for percentage of positive test results and hotspot status (i.e., increasing among in-person-instruction university counties). In-person instruction at colleges and universities was associated with increased county-level COVID-19 incidence and percentage test positivity. Implementation of increased mitigation efforts at colleges and universities could minimize on-campus COVID-19 transmission.

A Review of Measles Outbreak Cost Estimates From the United States in the Postelimination Era (2004-2017): Estimates by Perspective and Cost Type.

Despite the elimination of measles in the United States (US) in the year 2000, cases continue to occur, with measles outbreaks having occurred in various jurisdictions in the US in 2018 and 2019. Understanding the cost associated with measles outbreaks can inform cost-of-illness and cost-effectiveness studies of measles and measles prevention. We performed a literature review and identified 10 published studies from 2001 through 2018 that presented cost estimates from 11 measles outbreaks. The median total cost per measles outbreak was $152 308 (range, $9862-$1 063 936); the median cost per case was $32 805 (range, $7396-$76 154) and the median cost per contact was $223 (range, $81-$746). There were limited data on direct and indirect costs associated with measles. These findings highlight how costly measles outbreaks can be, the value of this information for public health department budgeting, and the importance of more broadly documenting the cost of measles outbreaks.

Tetanus, diphtheria and acellular pertussis (Tdap) vaccine for prevention of pertussis among adults aged 19 years and older in the United States: A cost-effectiveness analysis.

Currently, the Advisory Committee on Immunization Practices recommends one-time tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination for all adults 19 years and older. This study is designed to evaluate the cost-effectiveness of Tdap vaccination for Tdap-eligible adults aged 19 through 85 in the United States. A cost-effectiveness model was developed to compute costs and health outcomes associated with pertussis among 100,000 Tdap-eligible persons of each age cohort. From the societal perspective, the cost per quality-adjusted life-year (QALY) saved was evaluated under the vaccination scenarios. Sensitivity analyses were also conducted to evaluate the impacts of changes in key variables. All costs were adjusted to 2018 US$ with an annual discount rate of 3% applied to costs and outcomes. The incremental cost-effectiveness ratios (ICERs) for vaccinating US adults aged 19 to 85 with Tdap ranged from $248,000/QALY to $900,000/QALY. The lowest cost per QALY was found to be $248,000 for the age 65 cohort, followed by $332,000 for the cohort of age 19, and followed by $477,000 for the age 50 cohort. Sensitivity analysis showed the most dramatic changes in ICER occurred when changing the underreporting factor, vaccine effectiveness and vaccination costs. While Tdap vaccination may not be as cost effective as predicted earlier, it remains the best available preventive measure against pertussis. Further investigation of the true burden of pertussis disease among adults and the effectiveness of Tdap vaccination in this population is needed to better estimate the impact of Tdap vaccination.

Vaccination-Related Activities at Schools With Kindergartners: Evidence From a School Nurse Survey.

Vaccination coverage among children in kindergarten varies across the country and within states. We surveyed a convenience sample of kindergarten school nurses to investigate self-reported vaccination-related activities conducted at schools nationwide. The majority of the 1,435 kindergarten school nurses responding reported that their schools communicate with parents and guardians of undervaccinated students by phone (96%), postal mail (67%), newsletters (61%), and e-mail (59%). Most respondents reported documenting vaccination coverage in electronic systems (85%) and sharing coverage reports with health departments (69%). A total of 41% of school nurses worked with external partners for vaccination efforts, the most common support received from partners being vaccine administration (38%) and providing materials/vaccines (21%). School nurses also reported that 95% of kindergartners were up to date for all vaccines. School-based vaccination-related activities are essential to sustaining high levels of vaccination coverage for the protection of children at schools and in the broader community.

Estimating the Costs and Income of Providing Vaccination to Adults and Children.

INTRODUCTION: Vaccinations are recommended to prevent serious morbidity and mortality. However, providers' concerns regarding costs and payments for providing vaccination services are commonly reported barriers to adult vaccination. Information on the costs of providing vaccination is limited, especially for adults. METHODS: We recruited 4 internal medicine, 4 family medicine, 2 pediatric, 2 obstetrics and gynecology (OBGYN) practices, and 2 community health clinics in North Carolina to participate in a study to assess the economic costs and benefits of providing vaccination services for adults and children. We conducted a time-motion assessment of vaccination-related activities in the provider office and a survey to providers on vaccine management costs. We estimated mean cost per vaccination, minimum and maximum payments received, and income. RESULTS: Across all provider settings, mean cost per vaccine administration was $14 with substantial variation by practice setting (pediatric: $10; community health clinics: $15; family medicine: $17; OBGYN: $23; internal medicine: $23). When receiving the maximum payment, all provider settings had positive income for vaccination services. When receiving the minimum reported payments for vaccination services, pediatric and family medicine practices had positive income, internal medicine, and OBGYN practices had approximately equal costs and payments, and community health clinics had losses or negative income. CONCLUSIONS: Overall, vaccination service providers appeared to have small positive income from vaccination services. In some cases, providers experienced negative income, which underscores the need for providers and policymakers to design interventions and system improvements to make vaccination services financially sustainable for all provider types.

A review of the cost-effectiveness of adult influenza vaccination and other preventive services.

The Centers for Disease Control and Prevention recommend annual influenza vaccination of persons ≥6 months old. However, in 2016-17, only 43.3% of U.S. adults reported receiving an influenza vaccination. Limited awareness about the cost-effectiveness (CE) or the economic value of influenza vaccination may contribute to low vaccination coverage. In 2017, we conducted a literature review to survey estimates of the CE of influenza vaccination of adults compared to no vaccination. We also summarized CE estimates of other common preventive interventions that are recommended for adults by the U.S. Preventive Services Task Force. Results are presented as costs in US$2015 per quality-adjusted life-year (QALY) saved. Among adults aged 18-64, the CE of influenza vaccination ranged from $8000 to $39,000 per QALY. Assessments for adults aged ≥65 yielded lower CE ratios, ranging from being cost-saving to $15,300 per QALY. Influenza vaccination was cost-saving to $85,000 per QALY for pregnant women in moderate or severe influenza seasons and $260,000 per QALY in low-incidence seasons. For other preventive interventions, CE estimates ranged from cost-saving to $170,000 per QALY saved for breast cancer screening among women aged 50-74, from cost-saving to $16,000 per QALY for colorectal cancer screening, and from $27,000 to $600,000 per QALY for hypertension screening and treatment. Influenza vaccination in adults appears to have a similar CE profile as other commonly utilized preventive services for adults. Efforts to improve adult vaccination should be considered by adult-patient providers, healthcare systems and payers given the health and economic benefits of influenza vaccination.

Cost-effectiveness of hepatitis C treatment for patients in early stages of liver disease.

UNLABELLED: New treatments for hepatitis C virus (HCV) may be highly effective but are associated with substantial costs that may compel clinicians and patients to consider delaying treatment. This study investigated the cost-effectiveness of these treatments with a focus on patients in early stages of liver disease. We developed a state-transition (or Markov) model to calculate costs incurred and quality-adjusted life-years (QALYs) gained following HCV treatment, and we computed incremental cost-effectiveness ratios (cost per QALY gained, in 2012 US dollars) for treatment at different stages of liver disease versus delaying treatment until the subsequent liver disease stage. Our analysis did not include the potential treatment benefits associated with reduced non-liver-related mortality or preventing HCV transmission. All parameter values, particularly treatment cost, were varied in sensitivity analyses. The base case scenario represented a 55-year-old patient with genotype 1 HCV infection with a treatment cost of $100,000 and treatment effectiveness of 90%. In this scenario, for a 55-year-old patient with moderate liver fibrosis (Metavir stage F2), the cost-effectiveness of immediately initiating treatment at F2 (versus delaying treatment until F3) was $37,300/QALY. For patients immediately treated at F0 (versus delaying treatment until F1), the threshold of treatment costs that yielded $50,000/QALY and $100,000/QALY cost-effectiveness ratios were $22,200 and $42,400, respectively. CONCLUSION: Immediate treatment of HCV-infected patients with moderate and advanced fibrosis appears to be cost-effective, and immediate treatment of patients with minimal or no fibrosis can be cost-effective as well, particularly when lower treatment costs are assumed.

Estimating the Number of Patients Infected With Chronic HCV in the United States Who Meet Highest or High-Priority Treatment Criteria.

We estimated the number of people infected with HCV in the United States who would qualify for immediate treatment according to the 2014 guidance. We based fibrosis stage on biopsy results, when available, or on FIB-4 scores. We used laboratory tests and International Classification of Diseases, Ninth Revision, Clinical Modification codes to determine if patients had any qualifying comorbidities. Of the 2.7 million people with HCV infection, we assumed that 1.35 million (50%) had been diagnosed. We estimated 457, 000 met the highest and 356, 000 the high-priority criteria for treatment, indicating that as many as 813,000 people could be treated immediately with new therapies. These estimates can inform planning efforts to address clinical capacity constraints and treatment costs.

An historical perspective on health-risk awareness and unhealthy behaviour: cigarette smoking in the United States 1949-1981.

OBJECTIVE: This paper investigates the change through time in the perception of smoking-related health harm and smoking behaviour from 1949 to 1981. BACKGROUND AND CONTEXT: A variety of common behaviours can be linked to chronic disease risk-smoking, over-eating, and excessive sitting, to name a few. Changing behaviours to reduce exposure to such risks can be an effort that spans generations and decades. SETTING AND PARTICIPANTS: Respondents to Gallup Poll surveys in the United States from 1949, 1954, 1957, 1971, 1972, 1977 and 1981. METHODS: Graphical analysis and probit regression are used to investigate trends through time and statistical associations of smoking with the perception of smoking-related health risks and other socio-demographic variables. INTERVENTION AND MAIN VARIABLE STUDIED: Perceived smoking health risk. MAIN OUTCOME MEASURE: Smoking participation. RESULTS AND CONCLUSION: Our findings include the proportions of individuals who were self-reported smokers fell between 1949 and 1981, from 0.48 to 0.34. Among smokers, the proportion who believed smoking was harmful increased from 0.52 in 1949 to 0.81 in 1981. By 1981, the proportion of non-smokers who believed smoking was harmful was 0.98. A negative association between belief in smoking harm and the decision to smoke was shown in regression analysis. This association became more pronounced over the three decades under study.

Cost-Effectiveness Analysis of Routine Outreach and Catch-Up Campaign Strategies for Measles, Mumps, and Rubella Vaccination in Chuuk, Federated States of Micronesia.

OBJECTIVE: The Federated States of Micronesia (FSM) experience periodic outbreaks of vaccine-preventable diseases. Our objective was to assess the cost-effectiveness of routine outreach and catch-up campaign strategies for increasing vaccination coverage for the measles, mumps, and rubella (MMR) vaccine among children aged 12 months through 6 years in Chuuk, FSM. METHODS: We used a cost-effectiveness model to assess 4 MMR vaccination strategies from a public health perspective: routine outreach conducted 4 times per year (quarterly routine outreach), routine outreach conducted 2 times per year (biannual routine outreach), catch-up campaigns conducted once per year (annual catch-up campaign), and catch-up campaigns conducted every 2 years with quarterly routine outreach in non-catch-up campaign years (status quo). We calculated costs and outcomes during a 5-year model horizon and summarized results as incremental cost-effectiveness ratios. We analyzed the following public health outcomes: additional protected person-month (PPM), doses administered and protected people (ie, a child who completed a 2-dose MMR series). We conducted 1-way sensitivity analyses to evaluate the stability of incremental cost-effectiveness ratios and to identify influential model inputs. RESULTS: Among the 4 MMR vaccination strategies, quarterly routine outreach was the most effective and most expensive strategy, and biannual routine outreach was the least expensive and least effective strategy. Quarterly routine outreach (vs status quo) yielded approximately an additional 7001 PPMs and 132 vaccine doses administered, with incremental costs of about $4 per PPM, $193 per dose administered, and $123 per protected person. CONCLUSION: Routine outreach and catch-up campaign vaccination strategies can be important interventions to improve health in Chuuk, FSM. More frequent routine outreach events could improve MMR coverage and reduce the likelihood of outbreaks of vaccine-preventable diseases such as measles and mumps.

Estimating effects of improved drinking water and sanitation on cholera.

Demand for adequate provision of drinking-water and sanitation facilities to promote public health and economic growth is increasing in the rapidly urbanizing countries of the developing world. With a panel of data on Asia and Africa from 1990 to 2008, associations are estimated between the occurrence of cholera outbreaks, the case rates in given outbreaks, the mortality rates associated with cholera and two disease control mechanisms, drinking-water and sanitation services. A statistically significant and negative effect is found between drinking-water services and both cholera case rates as well as cholera-related mortality rates. A relatively weak statistical relationship is found between the occurrence of cholera outbreaks and sanitation services.

Public health impact and cost-effectiveness of 15-valent pneumococcal conjugate vaccine use among the pediatric population of the United States.

BACKGROUND: Although use of the 13-valent pneumococcal conjugate vaccine (PCV13) among children has reduced incidence of pneumococcal disease, a considerable burden of disease remains. PCV15 is a new vaccine that contains pneumococcal serotypes 22F and 33F in addition to serotypes contained in PCV13. To inform deliberations by the Advisory Committee on Immunization Practices on recommendations for PCV15 use among U.S. children, we estimated the health impact and cost-effectiveness of replacing PCV13 with PCV15 within the routine infant immunization program in the United States. We also assessed the impact and cost-effectiveness of a supplementary PCV15 dose among children aged 2-5 years who have already received a full PCV13 series. METHODS: We estimated the incremental number of pneumococcal disease events and deaths averted, costs per quality adjusted life-year (QALY) gained, and costs per life-year gained under different vaccination strategies using a probabilistic model following a single birth cohort of 3.9 million individuals (based on 2020 U.S. birth cohort). We assumed that vaccine effectiveness (VE) of PCV15 against the two additional serotypes was the same as the VE of PCV13. The cost of PCV15 use among children was informed from costs of PCV15 use among adults and from discussions with the manufacturer. RESULTS: Our base case results found that replacing PCV13 with PCV15 prevented 92,290 additional pneumococcal disease events and 22 associated deaths, while also saving $147 million in costs. A supplementary PCV15 dose among children aged 2-5 years who were fully vaccinated with PCV13 prevented further pneumococcal disease events and associated deaths but at a cost of more than $2.5 million per QALY gained. CONCLUSIONS: A further decrease in pneumococcal disease in conjunction with considerable societal cost savings could be expected from replacing PCV13 with PCV15 within the routine infant immunization program in the United States.

Data-Related Challenges in Cost-Effectiveness Analyses of Vaccines.

Cost-effectiveness analyses (CEAs) are often prepared to quantify the expected economic value of potential vaccination strategies. Estimated outcomes and costs of vaccination strategies depend on numerous data inputs or assumptions, including estimates of vaccine efficacy and disease incidence in the absence of vaccination. Limitations in epidemiologic data can meaningfully affect both CEA estimates and the interpretation of those results by groups involved in vaccination policy decisions. Developers of CEAs should be transparent with regard to the ambiguity and uncertainty associated with epidemiologic information that is incorporated into their models. We describe selected data-related challenges to conducting CEAs for vaccination strategies, including generalizability of estimates of vaccine effectiveness, duration and functional form of vaccine protection that can change over time, indirect (herd) protection, and serotype replacement. We illustrate how CEA estimates can be sensitive to variations in specific epidemiologic assumptions, with examples from CEAs conducted for the USA that assessed vaccinations against human papillomavirus and pneumococcal disease. These challenges are certainly not limited to these two case studies and may be relevant to other vaccines.

Projected risks and health benefits of vaccination against herpes zoster and related complications in US adults.

The Advisory Committee on Immunization Practices (ACIP) recommends recombinant zoster vaccine (RZV) to prevent against herpes zoster (HZ) and related complications in immunocompetent adults ≥50 y and immunocompromised adults ≥19 y. In 2019, a statistical safety signal for Guillain-Barré syndrome (GBS) following RZV was identified using data from the Vaccine Safety Datalink (VSD). Subsequently, the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and collaborators undertook additional analyses using Centers for Medicare & Medicaid Services (CMS) Medicare data to further investigate the potential risk of GBS following RZV. Concurrently, epidemiologic data suggested a potentially elevated risk of GBS following HZ in U.S. adults. Using data from these sources and a published simulation model, this study evaluated the health benefits and risks associated with vaccinating immunocompetent adults ≥50 y with RZV compared to no vaccination. In the base case analysis, RZV vaccination averted 43,000-63,000 cases of HZ, including GBS complications, per million vaccinated per 10-y age cohort compared to 3-6 additional cases of GBS projected following RZV per million vaccinated in the same population. This analysis highlights the projected health benefits of RZV vaccination compared to the relatively low potential risk of GBS following RZV.