Evaluate different non-continuous temperature-monitoring practices for detection of out-of-range temperatures (above or below the recommended temperature range of 2–8 °C for refrigeration units), which are called excursions, within vaccine storage units. Simulations based on temperature data collected by 243 digital data loggers operated in vaccine storage units at health-care providers who participated in a CDC-sponsored continuous temperature monitoring pilot project, from 2012 to 2015. In the primary analysis, we evaluate: (1) twice-daily current temperature readings without minimum and maximum readings (min/max), (2) twice-daily current temperature readings with once-daily min/max, and (3) twice-daily current temperature readings with twice-daily min/max. Recording current temperature twice daily without min/max resulted in the detection of 4.8—6.4% of the total number of temperature excursions. When min/max readings were introduced, the percentage of detected temperature excursions increased to 27.8—96.6% with once-daily min/max and to 34.8—96.7% with twice-daily min/max. Including min/max readings improves the ability of a temperature monitoring practice to detect temperature excursions. No combination of the non-continuous temperature monitoring practices were able to consistently detect all simulated temperature excursions.

This study aims to evaluate the cost-benefit of vaccination services, mostly partial series administration, provided by a mobile clinic program (MCP) in Houston for children of transient and low-income families. The study included 469 patients who visited the mobile clinics on regular service days in 2 study periods in 2014 and 836 patients who attended vaccination events in the summer of 2014. The benefit of partial series vaccination was estimated based on vaccine efficacy/effectiveness data. Our conservative cost-benefit estimates show that, compared with office-based settings, every dollar spent on vaccination by the MCP would result in $0.9 societal cost averted as an incremental benefit in regular service days and $3.7 during vaccination-only events. To further improve the cost-benefit of vaccination services in the MCP, decision-makers and stakeholders may consider improving work efficiency during regular service days or hosting more vaccination events.

Adult and adolescent vaccination rates are far below coverage targets in the United States. Our objective was to identify the most influential factors related to vaccine uptake among adults, adolescents, and parents of adolescents (parents) in the United States. We used a fractional factorial design to create a binary choice survey to evaluate preferences for vaccination. The national survey was fielded to a sample of adults, adolescents ages 13–17 years, and parents, using a national probability-based online research panel in November 2015. Respondents were presented with 5 profiles of a hypothetical vaccine and asked in a series of questions whether they would accept each vaccine. We analyzed the binary choice data using logistic regression in STATA v13 (College Station, TX) to calculate the odds that a participant would choose to accept the vaccine. We received completed responses from 334 (51%) of 652 adults, 316 (21%) of 1516 adolescents, and 339 (33%) of 1030 parents. Respondents were generally representative of the U.S. population. Vaccine effectiveness was the most influential factor in the choice to vaccinate for all groups. Other most influential factors were primary care provider (PCP) recommendation and the out-of-pocket cost of the vaccine. Other factors such as risk of illness, risk of vaccine side effects, vaccination location, and time for vaccination were not important in the decision to get vaccinated. Adults, adolescents, and parents are most sensitive to vaccine effectiveness, PCP recommendation, and out-of-pocket cost for vaccination in their decision to get vaccinated. Strong PCP recommendations that focus on vaccine effectiveness and health care policies that minimize out-of-pocket costs for vaccinations may increase vaccine uptake by adults and adolescents.

Vaccine purchase cost has grown substantially over the last few decades. A closer look at vaccine prices reveals that not all vaccines shared the same increasing pattern. Various factors, such as vaccine attributes, competition, and supply shortages, could relate to price changes. In this study, we examined whether a variety of factors influenced the prices of noninfluenza childhood vaccines purchased in the public sector from 1996 to 2014. The association differed among price-capped vaccines and combination vaccines. There was an increasing time trend in real prices for non-price-capped vaccines, which was mostly offset by the effect of market longevity. The effect of competition in lowering prices was more pronounced among non-price-capped vaccines when manufacturer and vaccine component fixed effects were excluded. Supply shortage, manufacturer name change, and number of vaccine doses in series showed no effect. The results may help policy makers better understand price behaviors and make more informed decisions in vaccine planning and financing.

Purpose: Measure the preferences of decision makers and researchers associated with the Advisory Committee on Immunization Practices (ACIP) regarding the recommended format for presenting health economics studies to the ACIP. Methods: We conducted key informant interviews and an online survey of current ACIP work group members, and current and previous ACIP voting members, liaison representatives, and ex-officio members to understand preferences for health economics presentations. These preferences included the presentation of results and sensitivity analyses, the role of health economics studies in decision making, and strategies to improve guidelines for presenting health economics studies. Best-worst scaling was used to measure the relative value of seven attributes of health economics presentations in vaccine decision making. Results: The best-worst scaling survey had a response rate of 51% (n = 93). Results showed that summary results were the most important attribute for decision making (mean importance score: 0.69) and intermediate outcomes and disaggregated results were least important (mean importance score: 0.71). Respondents without previous health economics experience assigned sensitivity analysis lower importance and relationship of the results to other studies higher importance than the experienced group (sensitivity analysis scores: 0.15 vs. 0.15 respectively; relationship of the results: 0.13 vs. 0.12 respectively). Key informant interviews identified areas for improvement to include additional information on the quality of the analysis and increased role for liaisons familiar with health economics. Conclusion: Additional specificity in health economics presentations could allow for more effective presentations of evidence for vaccine decision making. (C) 2018 Elsevier Ltd. All rights reserved.

OBJECTIVE:To estimate the societal economic and health impacts of Maine's school-based influenza vaccination (SIV) program during the 2009 A(H1N1) influenza pandemic. DATA SOURCES:Primary and secondary data covering the 2008-09 and 2009-10 influenza seasons. STUDY DESIGN:We estimated weekly monovalent influenza vaccine uptake in Maine and 15 other states, using difference-in-difference-in-differences analysis to assess the program's impact on immunization among six age groups. We also developed a health and economic Markov microsimulation model and conducted Monte Carlo sensitivity analysis. DATA COLLECTION:We used national survey data to estimate the impact of the SIV program on vaccine coverage. We used primary data and published studies to develop the microsimulation model. PRINCIPAL FINDINGS:The program was associated with higher immunization among children and lower immunization among adults aged 18-49 years and 65 and older. The program prevented 4,600 influenza infections and generated $4.9 million in net economic benefits. Cost savings from lower adult vaccination accounted for 54 percent of the economic gain. Economic benefits were positive in 98 percent of Monte Carlo simulations. CONCLUSIONS:SIV may be a cost-beneficial approach to increase immunization during pandemics, but programs should be designed to prevent lower immunization among nontargeted groups.

Objective: To evaluate the cost-effectiveness of seasonal inactivated influenza vaccination among pregnant women using data from three recent influenza seasons in the United States.Design, setting, and participants: We developed a decision-analytic model following a cohort of 5.2 million pregnant women and their infants aged <6 months to evaluate the cost-effectiveness of vaccinating women against seasonal influenza during pregnancy from a societal perspective. The main outcome measures were quality-adjusted life-year (QALY) gained and cost-effectiveness ratios. Data sources included surveillance data, epidemiological studies, and published vaccine cost data. Sensitivity analyses were also performed. All costs and outcomes were discounted at 3% annually.Main outcome measures: Total costs (direct and indirect), effects (QALY gains, averted case numbers), and incremental cost-effectiveness of seasonal inactivated influenza vaccination among pregnant women (cost per QALY gained).Results: Using a recent benchmark of 52.2% vaccination coverage among pregnant women, we studied a hypothetical cohort of 2,753,015 vaccinated pregnant women. With an estimated vaccine effectiveness of 73% among pregnant women and 63% among infants <6 months, QALY gains for each season were 305 (2010-2011), 123 (2011-2012), and 610 (2012-2013). Compared with no vaccination, seasonal influenza vaccination during pregnancy was cost-saving when using data from the 2010-2011 and 2012-2013 influenza seasons. The cost-effectiveness ratio was greater than $100,000/QALY with the 2011-2012 influenza season data, when CDC reported a low attack rate compared to other recent seasons.Conclusions: Influenza vaccination for pregnant women can reduce morbidity from influenza in both pregnant women and their infants aged <6 months. Seasonal influenza vaccination during pregnancy is cost-saving during moderate to severe influenza seasons. (C) 2016 Elsevier Ltd. All rights reserved.

While vaccination remains as one of the most cost-effective preventive strategies, the cost of fully immunizing a child has grown considerably over the last few decades. This study examines trends in non-influenza childhood vaccine purchase costs in the public sector from 1996 to 2014. Non-influenza vaccine purchase cost per child for children aged 0 through 18years was calculated based on public-sector purchase prices. Purchase cost changes were then decomposed into changes attributable to recommendation updates and changes attributable to price variation. The study analyzed the growth rate of combination vaccine prices separately and compared these prices with the sum of prices of component vaccines. It is found that the average annual growth rate of non-influenza vaccine purchase cost per child during 1996-2014 was 12.6%. The growth rate attributable to price changes was 1.0% on average. Combination vaccine prices showed greater variation. The study concludes that vaccine price variation was one but a minor reason for purchase cost changes. Recommendation updates, particularly the introduction of new vaccines, played a much larger role in raising the purchase costs. If the 12.6% annual growth rate found during 1996-2014 in the study continues to apply, the purchase costs of childhood vaccines may more than double by 2020.

Introduction: The United States experienced a substantial increase in reported pertussis cases over the last decade. Since 2005, persons 11 years and older have been routinely recommended to receive a single dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine. The objective of this analysis was to evaluate the potential impact and cost-effectiveness of recommending a second dose of Tdap.Methods: A static cohort model was used to calculate the epidemiologic and economic impact of adding a second dose of Tdap at age 16 or 21 years. Projected costs and outcomes were examined from a societal perspective over a 20-year period. Quality-adjusted Life Years (QALY) saved were calculated.Results: Using baseline pertussis incidence from the National Notifiable Diseases Surveillance System, Tdap revaccination at either age 16 or 21 years would reduce outpatient visits by 433 (5%) and 285 (4%), and hospitalization cases by 7 (7%) and 5 (5%), respectively. The costs per QALY saved with a second dose of Tdap were approximately US $19.7 million (16 years) and $26.2 million (21 years). In sensitivity analyses, incidence most influenced the model; as incidence increased, the costs per QALY decreased. To a lesser degree, initial vaccine effectiveness and waning of effectiveness also affected cost outcomes. Multivariate sensitivity analyses showed that under a set of optimistic assumptions, the cost per QALY saved would be approximately $163,361 (16 years) and $204,556 (21 years).Conclusion: A second dose ofTdap resulted in a slight decrease in the number of cases and other outcomes, and that trend is more apparent when revaccinating at age 16 years than at age 21 years. Both revaccination strategies had high dollar per QALY saved even under optimistic assumptions in a multivariate sensitivity analysis. Published by Elsevier Ltd.

ObjectiveTo determine the optimal level of vaccination coverage defined as the level that minimizes total costs and explore how economic results change with marginal changes to this level of coverage.MethodsA susceptible-infected-recovered-vaccinated model designed to represent theoretical infectious diseases was created to simulate disease spread. Parameter inputs were defined to include ranges that could represent a variety of possible vaccine-preventable conditions. Costs included vaccine costs and disease costs. Health benefits were quantified as monetized quality adjusted life years lost from disease. Primary outcomes were the number of infected people and the total costs of vaccination. Optimization methods were used to determine population vaccination coverage that achieved a minimum cost given disease and vaccine characteristics. Sensitivity analyses explored the effects of changes in reproductive rates, costs and vaccine efficacies on primary outcomes. Further analysis examined the additional cost incurred if the optimal coverage levels were not achieved.ResultsResults indicate that the relationship between vaccine and disease cost is the main driver of the optimal vaccination level. Under a wide range of assumptions, vaccination beyond the optimal level is less expensive compared to vaccination below the optimal level. This observation did not hold when the cost of the vaccine cost becomes approximately equal to the cost of disease.Discussion and ConclusionThese results suggest that vaccination below the optimal level of coverage is more costly than vaccinating beyond the optimal level. This work helps provide information for assessing the impact of changes in vaccination coverage at a societal level.

Purpose - To measure adolescent girls' preferences over features of human papillomavirus (HPV) vaccines in order to provide quantitative estimates of the perceived benefits of vaccination and potential vaccine uptake.Design/methodology/approach - A discrete choice experiment (DCE) survey was developed to measure adolescent girls' preferences over features of HPV vaccines. The survey was fielded to a U.S. sample of 307 girls aged 13-17 years who had not yet received an HPV vaccine in June 2008.Findings - In a latent class logit model, two distinct groups were identified - one with strong preferences against vaccination which largely did not differentiate between vaccine features, and another that was receptive to vaccination and had well-defined preferences over vaccine features. Based on the mean estimates over the entire sample, we estimate that girls' valuation of bivalent and quadrivalent HPV vaccines ranged between $400 and $460 in 2008, measured as willingness-to-pay (WTP). The additional value of genital warts protection was $145, although cervical cancer efficacy was the most preferred feature. We estimate maximum uptake of 54-65%, close to the 53% reported for one dose in 2011 surveillance data, but higher than the 35% for three doses in surveillance data.Research limitations/implications - We conclude that adolescent girls do form clear opinions and some place significant value on HPV vaccination, making research on their preferences vital to understanding the determinants of HPV vaccine demand.Originality/value - DCE studies may be used to design more effective vaccine-promotion programs and for reassessing public health recommendations and guidelines as new vaccines are made available.

OBJECTIVES:To evaluate the economic impact of the 2009 routine US childhood immunization schedule, including diphtheria and tetanus toxoids and acellular pertussis, Haemophilus influenzae type b conjugate, inactivated poliovirus, measles/mumps/rubella, hepatitis B, varicella, 7-valent pneumococcal conjugate, hepatitis A, and rotavirus vaccines; influenza vaccine was not included.METHODS:Decision analysis was conducted using population-based vaccination coverage, published vaccine efficacies, historical data on disease incidence before vaccination, and disease incidence reported during 2005 to 2009. Costs were estimated using the direct cost and societal (direct and indirect costs) perspectives. Program costs included vaccine, administration, vaccine-associated adverse events, and parent travel and work time lost. All costs were inflated to 2009 dollars, and all costs and benefits in the future were discounted at a 3% annual rate. A hypothetical 2009 US birth cohort of 4,261,494 infants over their lifetime was followed up from birth through death. Net present value (net savings) and benefit-cost ratios of routine childhood immunization were calculated.RESULTS:Analyses showed that routine childhood immunization among members of the 2009 US birth cohort will prevent ∼42,000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively. The direct and societal benefit-cost ratios for routine childhood vaccination with these 9 vaccines were 3.0 and 10.1.CONCLUSIONS:From both direct cost and societal perspectives, vaccinating children as recommended with these vaccines results in substantial cost savings.

The use of alternative venues beyond physician offices may help to increase rates of population influenza vaccination. Schools provide a logical setting for reaching children, but most school-located vaccination (SLV) efforts to date have been limited to local areas. The potential reach and acceptability of SLV at the national level is unknown in the United States. To address this gap, we conducted a nationally representative online survey of 1088 parents of school-aged children. We estimate rates of, and factors associated with, future hypothetical parental consent for children to participate in SLV for influenza. Based on logistic regression analysis, we estimate that 51% of parents would be willing to consent to SLV for influenza. Among those who would consent, SLV was reported as more convenient than the regular location (42.1% vs. 19.9%, P<0.001). However the regular location was preferred over SLV for the child's well-being in case of side effects (46.4% vs. 20.9%, P<0.001) and proper administration of the vaccine (31.0% vs. 21.0%, P<0.001). Parents with college degrees and whose child received the 2009-2010 seasonal or 2009 H1N1 influenza vaccination were more likely to consent, as were parents of uninsured children. Several measures of concern about vaccine safety were negatively associated with consent for SLV. Of those not against SLV, schools were preferred as more convenient to the regular location by college graduates, those whose child received the 2009-2010 seasonal or 2009 H1N1 influenza vaccination, and those with greater travel and clinic time. With an estimated one-half of U.S. parents willing to consent to SLV, this study shows the potential to use schools for large-scale influenza vaccination programs in the U.S.

Prevention of morbidity and mortality from pertussis in infants is challenging. Infants younger than 2 months have an annual incidence of pertussis of 160 per 100,000 and account for 57% and 85% of all infant hospitalizations and infant deaths, respectively. These infants are too young to be vaccinated with diphtheria-tetanus-acellular pertussis (DTaP) vaccines. One method to prevent infant pertussis infection is to vaccinate parents and close contacts with the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed (Tdap) booster vaccine. In a “cocooning” strategy, mothers are vaccinated with Tdap immediately postpartum, and other close contacts are vaccinated before the infant’s birth. In contrast, vaccination during the second or third trimester allows maternal antibody production to reach protective levels by delivery. This study was undertaken to assess a decision and cost-effectiveness model that compared pregnancy vaccination with postpartum vaccination with or without cocooning for preventing infant pertussis. A Markov cohort model was created to calculate health benefits, costs, and cost-effectiveness of pregnancy vaccination of mothers in the third trimester and of postpartum cocooning, using the 2009 US birth cohort of 4,131,019 infants followed up for 1 year. Probabilities of hospitalization with respiratory disease or death were calculated according to month of age from 2000 to 2007 data. Strategies analyzed were a pregnancy dose of Tdap, a postpartum dose of Tdap, and limited cocooning doses for the postpartum mother, father, and 1 grandparent. Strategies were compared with the primary DTaP series with no pregnancy or cocooning doses (ie, base case). For pregnancy vaccination, mothers were vaccinated during the third trimester and were considered to have full vaccine efficacy at delivery; fathers were not vaccinated. For postpartum vaccination, mothers were vaccinated immediately postpartum. For cocooning, mothers were vaccinated postpartum, and the father and a grandparent were vaccinated before delivery and considered immune when the infant was born. Cost per dose of vaccine was $37.60 with an administrative fee of $20. Outcomes were pertussis cases, hospitalizations and deaths prevented, and quality-adjusted life-years (QALYs) saved. Cost-effectiveness ratios were estimated using discounted QALYs, cases, and hospitalizations. For the base case, an estimated 3041 infant pertussis cases would occur annually, resulting in 1463 hospitalizations and 22 deaths. Postpartum vaccination, late pregnancy vaccination, and cocooning would avert, respectively, 596, 1012, and 987 infant cases annually, for a 20%, 33%, and 32% reduction from the base case, respectively. Most infant cases averted would occur in the first 2 months of life. Relative to the base case, pregnancy vaccination reduced infant hospitalizations by 38% and deaths by 49% compared with reductions of 32% and 29% for postpartum vaccination with cocooning. The annual cost for pregnancy or postpartum vaccination, with an estimated 3 million vaccine doses annually, was $171.2 million. If a father and 1 grandparent were included, $342 million would be added annually. Overall, pregnancy vaccination resulted in more QALYs saved per year when compared with postpartum vaccination and cocooning (396 QALYs vs 253 QALYs saved). For the same program cost, pregnancy vaccination would save more QALYs than postpartum vaccination. Cocooning did not save as many QALYs as pregnancy vaccination and had a higher program cost. Tdap vaccination during pregnancy can avert more infant pertussis cases, hospitalizations, and deaths than postpartum or cocooning strategies. The reduction in infant illness was due to earlier indirect protection by vaccinating the mother during pregnancy and by providing direct immunity to the infant through transplacental transfer of antibodies. These benefits were present early in infancy when morbidity and mortality are highest.

BACKGROUND: Infants <2 months of age are at highest risk of pertussis morbidity and mortality. Until recently, the US Advisory Committee on Immunization Practices (ACIP) recommended protecting young infants by "cocooning" or vaccination of postpartum mothers and other close contacts with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed (Tdap) booster vaccine. ACIP recommends pregnancy vaccination as a preferred and safe alternative to postpartum vaccination. The ACIP cocooning recommendation has not changed.METHODS: We used a cohort model reflecting US 2009 births and the diphtheria-tetanus-acellular pertussis schedule to simulate a decision and cost-effectiveness analysis of Tdap vaccination during pregnancy compared with postpartum vaccination with or without vaccination of other close contacts (ie, cocooning). We analyzed infant pertussis cases, hospitalizations, and deaths, as well as direct disease, indirect, and public health costs for infants in the first year of life. All costs were updated to 2011 US dollars.RESULTS: Pregnancy vaccination could reduce annual infant pertussis incidence by more than postpartum vaccination, reducing cases by 33% versus 20%, hospitalizations by 38% versus 19%, and deaths by 49% versus 16%. Additional cocooning doses in a father and 1 grandparent could avert an additional 16% of cases but at higher cost. The cost per quality-adjusted life-year saved for pregnancy vaccination was substantially less than postpartum vaccination ($414 523 vs $1 172 825).CONCLUSIONS: Tdap vaccination during pregnancy could avert more infant cases and deaths at lower cost than postpartum vaccination, even when postpartum vaccination is combined with additional cocooning doses. Pregnancy dose vaccination is the preferred alternative to postpartum vaccination for preventing infant pertussis.

BACKGROUND AND OBJECTIVE: Although effective in preventing pneumococcal disease, 13-valent pneumococcal conjugate vaccine (PCV13) is the most expensive vaccine on the routinely recommended pediatric schedule in the United States. We examined the cost-effectiveness of switching from 4 total doses to 3 total doses by removing the third dose in the primary series in the United States. METHODS: We used a probabilistic model following a single birth cohort of 4.3 million to calculate societal cost savings and increased disease burden from removing the 6-month dose of PCV13. Based on modified estimates of 7-valent pneumococcal conjugate vaccine from randomized trials and observational studies, we assumed that vaccine effectiveness under the 2 schedules is identical for the first 6 months of life and largely similar after administration of the 12- to 15-month booster dose. RESULTS: Removing the third dose of PCV13 would annually save $500 million (in 2011$) but would also result in an estimated 2.5 additional deaths among inpatients with pneumonia or invasive pneumococcal disease. Such dose removal would also result in 261 000 estimated otitis media and 12 000 estimated pneumonia cases annually. These additional illnesses could be prevented through modest increases in coverage. Overall, societal savings per additional life-year lost would be ∼$6 million. When nonfatal outcomes are also considered, savings would range from $143 000 to $4 million per additional quality adjusted life-year lost, depending on the assumptions used for otitis media. CONCLUSIONS: Sizable societal cost savings and a moderate pneumococcal disease increase could be expected from removing the PCV13 primary series’ third dose.

Recent research suggests that values for health-related quality of life may vary with the age of the patient. Traditional health state valuation questions and discrete choice experiments are two approaches that could be used to value health.

The recent impact of influenza on the working-age population of the US has led to changes in the recommendations for vaccination against seasonal influenza; however, the implications of vaccinating such a population have been debated. A review of cost-effectiveness analyses of vaccinating the working-age population of the US against seasonal influenza was conducted using articles published between January 1990 and January 2010. Studies considered for inclusion were identified using MEDLINE, EMBASE and Econlit. Reviewers worked in pairs, and each team member independently extracted relevant data using a standard abstraction form. The source and appropriateness of parameters (epidemiological data, probabilities and costs), the designs employed and the sufficiency of sensitivity analysis were considered during review. Key inputs extracted from the selected studies included influenza or influenza-like illness attack rates, outpatient visits averted, total vaccination days and lost workdays.Seven studies were identified as appropriate for this review. All studies were conducted in the US and from the societal perspective; three were randomized controlled trials and the remaining four were economic simulation models comparing vaccination and influenza antiviral drugs or no intervention; analyses focused on healthy working-age adults aged 18-49 years. Results ranged from net savings of $US68.96 to net costs of $US85.92 per person vaccinated (four studies) and net costs of $US104-1005 per episode of influenza averted (one study). Only two studies reported cost-effectiveness ratios; these ranged from $US26 565 to $US50 512 per quality-adjusted life-year gained. Nearly all of the studies conducted sensitivity analysis; results were most sensitive to variation in wage rates, levels of worker productivity, the costs and effectiveness of vaccination, and the rate of influenza illness. Review of the included studies suggests that seasonal influenza vaccination of healthy, working-age adults is generally not cost saving, requiring an investment to generate health benefits. The decision to vaccinate such a group will depend upon the societal and payer valuation of those benefits.