Growth in health care data causing an evolution in the pharmaceutical industry.

A health care ecosystem is evolving in which all stakeholders will need to work together, apply new technologies, and use disparate data sources to gain insights, increase efficiencies, and improve patient outcomes. The pharmaceutical industry is leveraging its experience and analytics capabilities to play an important role in this evolution.

Going Forward: Potential Impact of Protein-Based COVID-19 Vaccination Coverage on Population Outcomes and Costs in the United States.

Policymakers in the United States (US) recommend coronavirus disease 2019 (COVID-19) vaccination with a monovalent 2023-2024 vaccine formulation based on the Omicron XBB.1.5 variant. We estimated the potential US population-level health and economic impacts of increased COVID-19 vaccine coverage that might be expected with the availability of a protein-based vaccine with simpler storage requirements in addition to messenger ribonucleic acid (mRNA) vaccines. A Markov model was developed to estimate 1-year COVID-19-related costs, cases, hospitalizations, and deaths with and without the availability of a protein-based vaccine option. The model population was stratified by age and risk status. Model inputs were sourced from published literature or derived from publicly available data. Our model estimated that a five-percentage-point increase in coverage due to the availability of a protein-based vaccine option would prevent over 500,000 cases, 66,000 hospitalizations, and 3000 COVID-19-related deaths. These clinical outcomes translated to 42,000 quality-adjusted life years (QALYs) gained and an incremental cost-effectiveness ratio of USD 16,141/QALY from a third-party payer perspective. In sensitivity analyses, outcomes were most sensitive to COVID-19 incidence and severity across age groups. The availability of a protein-based vaccine option in the US could reduce hospitalizations and deaths and is predicted to be cost-effective.

COVID-19 Vaccine Preferences in General Populations in Canada, Germany, the United Kingdom, and the United States: Discrete Choice Experiment.

BACKGROUND: Despite strong evidence supporting COVID-19 vaccine efficacy and safety, a proportion of the population remains hesitant to receive immunization. Discrete choice experiments (DCEs) can help assess preferences and decision-making drivers. OBJECTIVE: We aim to (1) elicit preferences for COVID-19 vaccines in Canada, Germany, the United Kingdom, and the United States; (2) understand which vaccine attributes people there value; and (3) gain insight into the choices that different population subgroups make regarding COVID-19 vaccines. METHODS: Participants in the 2019nCoV-408 study were aged ≥18 years; self-reported antivaccinationists were excluded. A DCE with a series of 2 hypothetical vaccine options was embedded into a survey to determine participant treatment preferences (primary objective). Survey questions covered vaccine preference, previous COVID-19 experiences, and demographics, which were summarized using descriptive statistics to understand the study participants' backgrounds. In the DCE, participants were provided choice pairs: 1 set with and 1 without an "opt-out" option. Each participant viewed 11 unique vaccine profiles. Vaccine attributes consisted of type (messenger RNA or protein), level of protection against any or severe COVID-19, risk of side effects (common and serious), and potential coadministration of COVID-19 and influenza vaccines. Attribute level selections were included for protection and safety (degree of effectiveness and side effect risk, respectively). Participants were stratified by vaccination status (unvaccinated, or partially or fully vaccinated) and disease risk group (high-risk or non-high-risk). A conditional logit model was used to analyze DCE data to estimate preferences of vaccine attributes, with the percentage relative importance calculated to allow for its ranking. Each model was run twice to account for sets with and without the opt-out options. RESULTS: The mean age of participants (N=2000) was 48 (SD 18.8) years, and 51.25% (1025/2000) were male. The DCE revealed that the most important COVID-19 vaccine attributes were protection against severe COVID-19 or any severity of COVID-19 and common side effects. Protection against severe COVID-19 was the most important attribute for fully vaccinated participants, which significantly differed from the unvaccinated or partially vaccinated subgroup (relative importance 34.8% vs 30.6%; P=.049). Avoiding serious vaccine side effects was a significantly higher priority for the unvaccinated or partially versus fully vaccinated subgroup (relative importance 10.7% vs 8.2%; P=.044). Attributes with significant differences in the relative importance between the high-risk versus non-high-risk subgroups were protection against severe COVID-19 (38.2% vs 31.5%; P<.000), avoiding common vaccine side effects (12% vs 20.5%; P<.000), and avoiding serious vaccine side effects (9.7% vs 7.5%; P=.002). CONCLUSIONS: This DCE identified COVID-19 vaccine attributes, such as protection against severe COVID-19, that may influence preference and drive choice and can inform vaccine strategies. The high ranking of common and serious vaccine side effects suggests that, when the efficacy of 2 vaccines is comparable, safety is a key decision-making factor.

Reactogenicity Differences between Adjuvanted, Protein-Based and Messenger Ribonucleic Acid (mRNA)-Based COVID-19 Vaccines.

Participants in studies investigating COVID-19 vaccines commonly report reactogenicity events, and concerns about side effects may lead to a reluctance to receive updated COVID-19 vaccinations. A real-world, post hoc analysis, observational 2019nCoV-406 study was conducted to examine reactogenicity within the first 2 days after vaccination with either a protein-based vaccine (NVX-CoV2373) or an mRNA vaccine (BNT162b2 or mRNA-1273) in individuals who previously completed a primary series. Propensity score adjustments were conducted to address potential confounding. The analysis included 1130 participants who received a booster dose of NVX-CoV2373 (n = 303) or an mRNA vaccine (n = 827) during the study period. Within the first 2 days after vaccination, solicited systemic reactogenicity events (adjusted) were reported in 60.5% of participants who received NVX-CoV2373 compared with 84.3% of participants who received an mRNA vaccine; moreover, 33.9% and 61.4%, respectively, reported ≥3 systemic reactogenicity symptoms. The adjusted mean (95% CI) number of systemic symptoms was 1.8 (1.6-2.0) and 3.2 (3.0-3.4), respectively. Local reactogenicity events (adjusted) were reported in 73.4% and 91.7% of participants who received NVX-CoV2373 and mRNA vaccines, respectively; the adjusted mean (95% CI) number of local symptoms was 1.5 (1.33-1.61) and 2.4 (2.31-2.52), respectively. These results support the use of adjuvanted, protein-based NVX-CoV2373 as an immunization option with lower reactogenicity than mRNAs.

Burden and Impact of Reactogenicity among Adults Receiving COVID-19 Vaccines in the United States and Canada: Results from a Prospective Observational Study.

As SARS-CoV-2 variants continue to emerge, vaccination remains a critical tool to reduce the COVID-19 burden. Vaccine reactogenicity and the impact on work productivity/daily activities are recognized as contributing factors to vaccine hesitancy. To encourage continued COVID-19 vaccination, a more complete understanding of the differences in reactogenicity and impairment due to vaccine-related side effects across currently available vaccines is necessary. The 2019nCoV-406 study (n = 1367) was a prospective observational study of reactogenicity and associated impairments in adults in the United States and Canada who received an approved/authorized COVID-19 vaccine. Compared with recipients of mRNA COVID-19 booster vaccines, a smaller percentage of NVX-CoV2373 booster recipients reported local and systemic reactogenicity. This study's primary endpoint (percentage of participants with ≥50% overall work impairment on ≥1 of the 6 days post-vaccination period) did not show significant differences. However, the data suggest that NVX-CoV2373 booster recipients trended toward being less impaired overall than recipients of an mRNA booster; further research is needed to confirm this observed trend. The results of this real-world study suggest that NVX-CoV2373 may be a beneficial vaccine option with limited impact on non-work activities, in part due to the few reactogenicity events after vaccination.

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials.

BACKGROUND: NVX-CoV2373 (Nuvaxovid™ or the Novavax COVID-19 Vaccine, Adjuvanted), the first protein-based COVID-19 vaccine, received emergency use authorization (EUA) as a primary series/booster and is available globally. NVX-CoV2373 primary series demonstrated efficacy rates of 89.7-90.4 % and an acceptable safety profile. This article summarizes safety in adult recipients (aged ≥ 18 years) of primary series NVX-CoV2373 in four randomized placebo-controlled trials. METHODS: All participants who received NVX-CoV2373 primary series or placebo (pre-crossover) were included according to actual received treatment. The safety period was from Day 0 (first vaccination) to unblinding/receipt of EUA-approved/crossover vaccine, end of each study (EOS), or last visit date/cutoff date minus 14 days. The analysis reviewed local and systemic solicited adverse events (AEs) within 7 days after NVX-CoV2373 or placebo; unsolicited AEs from after Dose 1 to 28 days after Dose 2; serious AEs (SAEs), deaths, AEs of special interest, and vaccine-related medically attended AEs from Day 0 through end of follow-up (incidence rate per 100 person-years). FINDINGS: Pooled data from 49,950 participants (NVX-CoV2373, n = 30,058; placebo, n = 19,892) were included. Solicited reactions after any dose were more frequent in NVX-CoV2373 recipients (local, 76 %/systemic, 70 %) than placebo recipients (local, 29 %/systemic, 47 %), and were mostly of mild-to-moderate severity. Grade 3+ reactions were infrequent, with greater frequency in NVX-CoV2373 recipients (local, 6.28 %/systemic, 11.36 %) than placebo recipients (local, 0.48 %/systemic, 3.58 %). SAEs and deaths occurred with similarly low frequency in NVX-CoV2373 (SAEs: 0.91 %, deaths: 0.07 %) and placebo recipients (SAEs: 1.0 %, deaths: 0.06 %). INTERPRETATION: To date, NVX-CoV2373 has displayed an acceptable safety profile in healthy adults. FUNDING: Supported by Novavax, Inc.

Agreement between Internet-based self- and proxy-reported health care resource utilization and administrative health care claims.

OBJECTIVES: Although Internet-based surveys are becoming more common, little is known about agreement between administrative claims data and Internet-based survey self- and proxy-reported health care resource utilization (HCRU) data. This analysis evaluated the level of agreement between self- and proxy-reported HCRU data, as recorded through an Internet-based survey, and administrative claims-based HCRU data. METHODS: The Child and Household Influenza-Illness and Employee Function study collected self- and proxy-reported HCRU data monthly between November 2007 and May 2008. Data included the occurrence and number of visits to hospitals, emergency departments, urgent care centers, and outpatient offices for a respondent's and his or her household members' care. Administrative claims data from the MarketScan® Databases were assessed during the same time and evaluated relative to survey-based metrics. Only data for individuals with employer-sponsored health care coverage linkable to claims were included. The Kappa (κ) statistic was used to evaluate visit concordance, and the intraclass correlation coefficient was used to describe frequency consistency. RESULTS: Agreement for presence of a health care visit and the number of visits were similar for self- and proxy-reported HCRU data. There was moderate to substantial agreement related to health care visit occurrence between survey-based and claims-based HCRU data for inpatient, emergency department, and office visits (κ: 0.47-0.77). There was less agreement on health care visit frequencies, with intraclass correlation coefficient values ranging from 0.14 to 0.71. CONCLUSIONS: This study's agreement values suggest that Internet-based surveys are an effective method to collect self- and proxy-reported HCRU data. These results should increase confidence in the use of the Internet for evaluating disease burden.

Elementary school-located influenza vaccine programs: key stakeholder experiences from initiation to continuation.

This study examined the initiation and logistics, funding, perceived barriers and benefits, and disruption of school activities by school-located influenza vaccination (SLIV) programs conducted during the 2008-2009 influenza season. Seventy-two interviews using a structured protocol were conducted with 26 teachers, 16 school administrators, and 30 health care professionals from 34 schools in 8 school districts. SLIV programs used a variety of locations, scheduling and staffing options, and methods for receiving parental consent and screening children. Health care professionals were primarily responsible for implementing SLIV programs, and most administrators and health care professionals considered programs easy to initiate. Health care professionals identified successful programs as requiring adequate planning/coordination, a dedicated program coordinator, and a consistent funding source. Most respondents (96%) reported minimal school-day disruptions. The perception of most stakeholders is that SLIV programs can be relatively easy to initiate, minimally disruptive and can become more efficient with experience, especially with feedback from all stakeholders.

Impact of adherence to treatment with inhaled corticosteroids/long-acting ß-agonists on asthma outcomes in the United States.

BACKGROUND: Suboptimal adherence to maintenance medication has been associated with poor outcomes in asthma. This study examined single-inhaler inhaled corticosteroid (ICS)/long-acting ß2 agonist (LABA) adherence and asthma-related outcomes. METHODS: This retrospective observational study of patients with asthma initiating ICS/LABA used data from IQVIA PharMetrics Plus (1 January 2014-31 March 2019). Patients included were ⩾18 years old and had ⩾12 months continuous eligibility before, and ⩾180 days follow-up after, the index date. Adherence was measured as proportion of days covered ([PDC] adherent ⩾ 0.8; non-adherent <0.8) each quarter, with outcomes measured each subsequent quarter. Endpoints were asthma-related overall and severe (inpatient/emergency department [ED] visit) exacerbations, rescue medication use, and asthma-related healthcare resource utilization and costs. Regression models evaluated associations between adherence and outcomes, controlling for repeated measures and differences in baseline characteristics. RESULTS: Overall, 50,037 patients were included (mean age 45.3 years; mean follow-up 23.3 months). Adherent patients were less likely to experience asthma-related overall (adjusted odds ratio [aOR] 95% confidence interval [CI]: 0.942 [0.890, 0.998]; p = 0.041), or severe exacerbations (aOR [95% CI]: 0.778 [0.691, 0.877]; p < 0.001) per quarter versus non-adherent patients. Adherent patients had lower severe exacerbation rates (adjusted rate ratio [aRR] [95% CI]: 0.792 [0.702, 0.893]; p < 0.001) but similar overall exacerbation rates (aRR [95% CI]: 0.993 [0.945, 1.044]; p = 0.783) versus non-adherent patients. The odds of rescue medication use were lower per 20% PDC increase (aOR [95% CI] short-acting ß2 agonist: 0.991 [0.985, 0.996]; p = 0.001; oral corticosteroid: 0.988 [0.982, 0.995]; p < 0.001). Adherent patients were less likely to visit EDs per quarter (aOR [95% CI]: 0.775 [0.680, 0.883]; p < 0.001) and odds of hospitalization were lower per 20% PDC increase (aOR [95% CI]: 0.930 [0.881, 0.982]; p = 0.009). Across most measures, adherent patients incurred lower costs. CONCLUSION: This real-world study highlights the short-term clinical and economic benefits of ICS/LABA adherence in asthma, particularly in reducing severe exacerbations.

The longitudinal link between visual acuity and health-related quality of life in patients with diabetic retinopathy.

BACKGROUND: This study characterized the degree of change in health-related quality of life (HRQL) associated with change in visual acuity among patients with diabetic retinopathy. METHODS: Data are from a randomized, placebo-controlled trial of ruboxistaurin for vision loss in patients with diabetic retinopathy. Visual acuity was quantified as letters on the ETDRS visual acuity chart. HRQL was assessed with the 25-Item Visual Function Questionnaire (VFQ-25) and the SF-36. Patients were categorized into groups based on visual acuity change from baseline to month 18. HRQL change of these groups was compared using general linear models. Regression analyses examined visual acuity change defined continuously. RESULTS: Patients (N = 535) were primarily Caucasian (81.9%) and male (64.1%); mean age = 59.3 years. Compared to patients whose visual acuity did not change, the group with > 10 letters vision loss had significantly greater decreases in all VFQ-25 subscales except ocular pain. SF-36 change scores did not correspond as closely to change in vision. Change in visual acuity defined continuously was significantly associated with change in all VFQ-25 scales except ocular pain (p < 0.0001). CONCLUSION: Change in visual acuity was associated with corresponding changes in HRQL among patients with diabetic retinopathy. Previous research has often defined vision loss as a loss of at least 15 letters on the ETDRS visual acuity chart. In the current study, however, a loss of at least 10 letters was associated with substantial declines in HRQL domains such as driving, dependency, role limitations, and mental health. These findings suggest that patients who experience vision loss of at least 10 letters may be appropriate targets of future research and clinical intervention.

Prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy and diabetic retinopathy.

BACKGROUND: We estimated the prevalence and the associated burden of illness of symptoms of diabetic peripheral neuropathy (SDPN), diabetic retinopathy (DR), and comorbid SDPN and DR among people with diabetes in the United States aged > or =40 years. METHODS: Analyses were conducted on 850 respondents aged > or =40 years with diagnosed diabetes from the combined 1999-2000 and 2001-2002 National Health and Nutrition Examination Surveys. Sampling weights were used to estimate the number of people with diabetes who have SDPN, DR, or comorbid SDPN and DR. Multivariate regression models were used to assess the effects of SDPN, DR, and comorbid SDPN and DR on burden-of-illness measures. RESULTS: Approximately 11.9 million adults in the United States aged > or =40 years have diagnosed diabetes. Of those, 3.9 million (32.7%) have SDPN, 3.3 million (27.4%) have DR, and 1.6 million (13.1%) have comorbid SDPN and DR. Among our sample, those with SDPN [odds ratio (OR)=2.25; 95% confidence interval (95% CI)=1.32-3.83], DR (OR=1.68; 95% CI=1.08-2.61), or comorbid SDPN and DR (OR=2.84; 95% CI=1.26-6.41) were more likely than those without the corresponding condition to have four or more health care visits in the past year. Those of working age (40-65 years) with SDPN (OR=3.23; 95% CI=1.60-6.52), DR (OR=2.94; 95% CI=1.45-5.97), or comorbid SDPN and DR (OR=4.32; 95% CI=2.17-8.63) were more likely unable to work due to physical limitations. CONCLUSIONS: SDPN, DR, and comorbid SDPN and DR are prevalent among people with diabetes in the United States aged > or =40 years; each of these complications appears to significantly increase the burden of illness.

Cost-effectiveness of preventative therapies for postmenopausal women with osteopenia.

BACKGROUND: Limited data are available regarding the cost-effectiveness of preventative therapies for postmenopausal women with osteopenia. The objective of the present study was to evaluate the cost-effectiveness of raloxifene, alendronate and conservative care in this population. METHODS: We developed a microsimulation model to assess the incremental cost and effectiveness of raloxifene and alendronate relative to conservative care. We assumed a societal perspective and a lifetime time horizon. We examined clinical scenarios involving postmenopausal women from 55 to 75 years of age with bone mineral density T-scores ranging from -1.0 to -2.4. Modeled health events included vertebral and nonvertebral fractures, invasive breast cancer, and venous thromboembolism (VTE). Raloxifene and alendronate were assumed to reduce the incidence of vertebral but not nonvertebral fractures; raloxifene was assumed to decrease the incidence of breast cancer and increase the incidence of VTEs. Cost-effectiveness is reported in $/QALYs gained. RESULTS: For women 55 to 60 years of age with a T-score of -1.8, raloxifene cost approximately $50,000/QALY gained relative to conservative care. Raloxifene was less cost-effective for women 65 and older. At all ages, alendronate was both more expensive and less effective than raloxifene. In most clinical scenarios, raloxifene conferred a greater benefit (in QALYs) from prevention of invasive breast cancer than from fracture prevention. Results were most sensitive to the population's underlying risk of fracture and breast cancer, assumed efficacy and costs of treatment, and the discount rate. CONCLUSION: For 55 and 60 year old women with osteopenia, treatment with raloxifene compares favorably to interventions accepted as cost-effective.

Economic burden of osteoporosis, breast cancer, and cardiovascular disease among postmenopausal women in an employed population.

BACKGROUND: Postmenopausal women have a significant risk of developing a number of chronic conditions including osteoporosis (OP), breast cancer (BrCa), and cardiovascular disease (CVD). These diseases can result in significant direct (medical treatment) and indirect (workplace) costs. The objective of this study is to assess these costs among an employed population. METHODS: Deidentified medical and disability claims data from seven large employers (n = 585,441) were analyzed from 1998 through 2000 for female employees, age 50-64 years. Medical claim ICD-9CM codes were used to identify patients treated for: OP (n = 2,314), BrCa (n = 555), and CVD (n = 1,710). Each disease cohort was compared to a random sample of 50- to 64-year-old female employees (n = 7,575). Descriptive and multivariate techniques were used to characterize direct and indirect costs attributable to each condition. RESULTS: Average annual direct costs were higher (p < .001) for female employees treated for OP (6,259 dollars), BrCa (13,925 dollars), or CVD (12,055 dollars) when compared with the random sample (2,951 dollars). In addition, average annual indirect costs associated with OP (4,039 dollars), BrCa (8,236 dollars), and CVD (4,990 dollars) were higher (p < .001) than indirect costs for the random sample (2,292 dollars). Even when controlling for each disease-state cohort's demographics and disease-specific comorbidities, patients treated for OP, BrCa, and CVD continued to have significantly greater direct and indirect costs (p < .001) than the random sample. CONCLUSIONS: Chronic conditions such as OP, BrCa, and CVD, which occur more frequently in women after menopause, impose a significant financial burden. Greater health care utilization and work-loss prevalence among women treated for these conditions contribute to these additional costs.

Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study*.

BACKGROUND: Influenza B strains from two distinct lineages (Yamagata and Victoria) have cocirculated over recent years. Current seasonal vaccines contain a single B lineage resulting in frequent mismatches between the vaccine strain and the circulating strain. An Ann Arbor strain quadrivalent live attenuated influenza vaccine (Q/LAIV) containing B strains from both lineages is being developed to address this issue. OBJECTIVES: The goal of this study was to evaluate whether Q/LAIV administered intranasally as a single dose to a single nostril, using a blow-fill-seal (BFS) delivery system had a similar immunogenicity and safety profile compared with the licensed trivalent vaccine delivered using the Accuspray device. PATIENTS/METHODS: Adults aged 18-49 years were randomized to receive one intranasal dose of Q/LAIV delivered using a BFS device (Q/LAIV-BFS; n=1202) or one of two trivalent live attenuated influenza vaccines (T/LAIV) containing one of the corresponding B strains (total T/LAIV, n=598). Primary endpoints were the post-vaccination strain-specific serum hemagglutination inhibition antibody geometric mean titers for each strain. Secondary immunogenicity endpoints, safety, and acceptability of the BFS device were also assessed. RESULTS: Q/LAIV was immunogenically non-inferior to T/LAIV for all four influenza strains. Secondary immunogenicity outcomes were consistent with the primary endpoint. Solicited symptoms and AEs were comparable in both groups. Subjects considered the BFS device to be acceptable. CONCLUSIONS: Immune responses to vaccination with Ann Arbor strain Q/LAIV-BFS were non-inferior to those with T/LAIV. Q/LAIV may confer broader protection against seasonal influenza B by targeting both major influenza B lineages.

The comparative value of various employer-sponsored influenza vaccination clinics.

OBJECTIVE: Many US firms offer influenza vaccination clinics to prevent lost productivity due to influenza. Strategies to promote and offer vaccination differ, and the economic value of the strategies is unknown. METHODS: Decision analytic modeling and Monte Carlo probabilistic sensitivity analyses estimated the one-season cost-consequences of three types of influenza clinics (trivalent inactivated influenza vaccine only, vaccine choice [trivalent inactivated influenza or intranasal {live attenuated influenza} vaccine], or vaccine choice plus incentive) in firms of 50 and 250 employees, from the employer's perspective. RESULTS: On-site influenza vaccination was generally cost-saving over no vaccination. For the scenario of vaccine effectiveness of 70% and intermediate transmissibility, the incremental costs per employee for a firm of 50 employees were -$6.41 (ie, cost savings) for inactivated vaccine only versus no vaccination, -$1.48 for vaccine choice versus inactivated vaccine, and $1.84 for vaccine choice plus incentive versus vaccine choice. Clinics offering a choice of vaccines were slightly less costly under many scenarios. Generally, incremental costs were lower (1) in larger firms; (2) when influenza was assumed to be more contagious; and (3) when vaccine effectiveness was assumed to be higher. CONCLUSION: Employer-sponsored influenza vaccination clinics are generally cost-saving.

Children's perceptions of influenza illness and preferences for influenza vaccine.

INTRODUCTION: In this qualitative study we explored children's perceptions of influenza, preferences for influenza vaccines, and ability to understand "risk" of vaccine adverse effects and different attributes between injectable and intranasal vaccines. METHOD: In-person, semi-structured interviews were conducted among 28 U.S. children aged 6 through 12 years. RESULTS: Many children understood the concept of influenza illness and believed vaccination was important. Efficacy, adverse effects, and mode of administration affected their preferences for influenza vaccines. Children 8 years of age and older were able to consider multiple attributes when selecting between hypothetical vaccines, and their responses were consistent with their previously stated preferences for individual attributes. Most children would prefer a nasal spray over a shot vaccine when all other vaccine attributes were equal. DISCUSSION: Efficacy, adverse effects, and mode of administration were important factors in children's preferences for influenza vaccine. Children as young as 8 years of age appeared to understand vaccine "risk" and were able to consider multiple attributes simultaneously when choosing between vaccine alternatives.

A survey of children's preferences for influenza vaccine attributes.

BACKGROUND: While annual influenza vaccination is recommended by the CDC for children 6 months and older, vaccination rates remain suboptimal. For healthy, US children 2 years of age and older, influenza vaccine is available as an intramuscular injection (TIV) or an intranasal spray (LAIV), respectively. Little is known about children's experiences and preferences for influenza vaccine attributes. OBJECTIVE: To examine preferences for influenza vaccine attributes and their relative importance among children. METHODS: A quantitative web-survey was administered to children aged 8-12 years sampled from a standing online panel representative of the US population. Children were stratified by age, gender and parent's influenza vaccination behavior. The survey included questions to ascertain children's preferences for influenza vaccine attributes, including efficacy, chance of common side effects, and mode of administration. It included conjoint (trade-off) questions in which children traded-off different attributes in their choice between two influenza vaccines with differing features. We also surveyed children's comprehension of and ability to complete the conjoint questions. RESULTS: 544 children completed the survey (response rate 37%). Children most frequently selected efficacy as the most important vaccine attribute followed by mode of administration (45% and 31%, respectively). When asked for their preference to receive influenza vaccine as a "shot" or a "nose spray", the majority (69%) preferred the nose spray. An evaluation of children's ability to complete the conjoint survey demonstrated that 85% of the sample was able to complete the conjoint tasks. Analysis of the conjoint responses demonstrated that mode of administration and efficacy had the greatest impact on preferences, with a relative importance of 40.5% and 30.6%, respectively. In a direct comparison of vaccine profiles representing the efficacy, side effects, and other characteristics of LAIV and TIV, 79% of children preferred the LAIV-like profile. CONCLUSION: Children in the sample had consistent opinions regarding influenza vaccine attributes and consider vaccine efficacy and mode of administration to be important. Children can be informed participants in influenza prevention and can be included in discussions regarding influenza vaccination.

Parent preferences for pediatric influenza vaccine attributes.

Influenza vaccine is available as an intramuscular injection or an intranasal spray for eligible children. This study was conducted to examine parents' preferences for influenza vaccine attributes and the attributes' relative importance regarding the vaccination of their children. A quantitative Web survey was administered to 500 parents of children aged 2 to 12 years. The survey included general preference questions and conjoint (trade-off) questions. Parents most frequently selected efficacy, risk of temporary side effects, and physician recommendation as important vaccine attributes from a provided list (92%, 75%, and 59%, respectively). For attributes selected as important, parents rated the importance of the attribute; the highest mean importance ratings were given to efficacy, presence of mercury-containing preservative, and physician recommendation.The highest relative importance ratings in the conjoint section were given to efficacy and presence of mercury-containing preservative. Parental education on influenza vaccine efficacy and safety may help to improve pediatric vaccination rates.

Strategies for implementing school-located influenza vaccination of children: a systematic literature review.

BACKGROUND: The Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccinations for all children 6 months to 18 years of age, which includes school-aged children. Influenza immunization programs may benefit schools by reducing absenteeism. METHODS: A systematic literature review of PubMed, PsychLit, and Dissertation Abstracts available as of January 7, 2008, was conducted for school-located vaccinations, using search words "School Health Services" and "Immunization Programs"; limited to "Child" (6-12 years) and "Adolescent" (13-18 years) for PubMed and "mass or universal" and (immuniz(*) or immunis(*) or vaccin(*)) and (school or Child or Adolescen(*)) for PsychLit and Dissertation Abstracts. Fifty-nine studies met the criteria for review. RESULTS: Strategies such as incentives, education, the design of the consent form, and follow-up can increase parental consent and number of returned forms. Minimizing out-of-pocket cost, offering both the intramuscular (shot) and intranasal (nasal spray) vaccination, and using reminders can increase vaccination coverage among those whose parents consented. Finally, organization, communication, and planning can minimize the logistical challenges. CONCLUSIONS: Schools-based vaccination programs are a promising option for achieving the expanded ACIP recommendation; school-located vaccination programs are feasible and effective. Adhering to lessons from the peer-reviewed scientific literature may help public health officials and schools implement the expanded recommendation to provide the greatest benefit for the lowest cost. Given the potential benefits of the expanded recommendation, both directly to the vaccinated children and indirectly to the community, prospective, well-controlled trials to establish the cost-effectiveness of specific vaccination strategies should be high priorities for future research.