Analysis of Myocarditis Among 252 Million mRNA-1273 Recipients Worldwide.

BACKGROUND: Growing evidence indicates a causal relationship between SARS-CoV-2 infection and myocarditis. Post-authorization safety data have also identified myocarditis as a rare safety event following mRNA COVID-19 vaccination, particularly among adolescent and young-adult males after dose 2. We further evaluated the potential risk by querying the Moderna global safety database for myocarditis/myopericarditis reports among mRNA-1273 recipients worldwide. METHODS: Myocarditis/myopericarditis reports from 18 December 2020 to 15 February 2022 were reviewed and classified. The reported rate after any known mRNA-1273 dose was calculated according to age and sex, then compared with a population-based incidence rate to calculate observed-to-expected rate ratios (RRs). RESULTS: During the study period, 3017 myocarditis/myopericarditis cases among 252 million mRNA-1273 recipients who received at least 1 dose were reported to the Moderna global safety database. The overall reporting rate was 9.23 per 100 000 person-years, which was similar to the expected reference rate (9.0 cases per 100 000 person-years; RR [95% confidence interval (CI)], 1.03 [.97-1.08]). When stratified by sex and age, observed rates were highest for males aged <40 years, particularly those 18-24 years (53.76 per 100 000 person-years), which was higher than expected (RR [95% CI], 3.10 [2.68-3.58]). When considering only cases occurring within 7 days of a known dose, the observed rate was highest for males aged 18-24 years after dose 2 (4.23 per 100 000 doses administered). CONCLUSIONS: Myocarditis/myopericarditis rates were not higher than expected for the overall population of mRNA-1273 recipients but were higher than expected in males aged 18-24 years, with most cases occurring 7 days after dose 2.

Relative Effectiveness of the Cell-derived Inactivated Quadrivalent Influenza Vaccine Versus Egg-derived Inactivated Quadrivalent Influenza Vaccines in Preventing Influenza-related Medical Encounters During the 2018-2019 Influenza Season in the United States.

BACKGROUND: The cell-propagated inactivated quadrivalent influenza vaccine (ccIIV4) may offer improved protection in seasons where egg-derived influenza viruses undergo mutations that affect antigenicity. This study estimated the relative vaccine effectiveness (rVE) of ccIIV4 versus egg-derived inactivated quadrivalent influenza vaccine (eIIV4) in preventing influenza-related medical encounters in the 2018-2019 US season. METHODS: A dataset linking primary care electronic medical records with medical claims data was used to conduct a retrospective cohort study among individuals ≥ 4 years old vaccinated with ccIIV4 or eIIV4 during the 2018-2019 season. Adjusted odds ratios (ORs) were derived from a doubly robust inverse probability of treatment-weighted approach adjusting for age, sex, race, ethnicity, geographic region, vaccination week, and health status. rVE was estimated by (1 - OR) × 100 and presented with 95% confidence intervals (CI). RESULTS: Following the application of inclusion/exclusion criteria, the study cohort included 2 125 430 ccIIV4 and 8 000 903 eIIV4 recipients. Adjusted analyses demonstrated a greater reduction in influenza-related medical encounters with ccIIV4 versus eIIV4, with the following rVE: overall, 7.6% (95% CI, 6.5-8.6); age 4-17 years, 3.9% (95% CI, .9-7.0); 18-64 years, 6.5% (95% CI, 5.2-7.9); 18-49 years, 7.5% (95% CI, 5.7-9.3); 50-64 years, 5.6% (95% CI, 3.6-7.6); and ≥65 years, -2.2% (95% CI, -5.4 to .9). CONCLUSIONS: Adjusted analyses demonstrated statistically significantly greater reduction in influenza-related medical encounters in individuals vaccinated with ccIIV4 versus eIIV4 in the 2018-2019 US influenza season. These results support ccIIV4 as a potentially more effective public health measure against influenza than an egg-based equivalent.

Relative Effectiveness of Adjuvanted Trivalent Inactivated Influenza Vaccine Versus Egg-derived Quadrivalent Inactivated Influenza Vaccines and High-dose Trivalent Influenza Vaccine in Preventing Influenza-related Medical Encounters in US Adults ≥ 65 Years During the 2017-2018 and 2018-2019 Influenza Seasons.

BACKGROUND: The effectiveness of standard, egg-derived quadrivalent influenza vaccines (IIV4) may be reduced in adults ≥65 years of age, largely because of immunosenescence. An MF59-adjuvanted trivalent influenza vaccine (aIIV3) and a high-dose trivalent influenza vaccine (HD-IIV3) offer older adults enhanced protection versus standard vaccines. This study compared the relative effectiveness of aIIV3 with IIV4 and HD-IIV3 in preventing influenza-related medical encounters over 2 US influenza seasons. METHODS: This retrospective cohort study included US patients ≥65 years vaccinated with aIIV3, IIV4, or HD-IIV3. The outcome of interest was the occurrence of influenza-related medical encounters. Data were derived from a large dataset comprising primary and specialty care electronic medical records linked with pharmacy and medical claims. Adjusted odds ratios (OR) were derived from an inverse probability of treatment-weighted sample adjusted for age, sex, race, ethnicity, geographic region, vaccination week, and health status. Relative vaccine effectiveness (rVE) was determined using the formula (% VE = 1 - ORadjusted) × 100. RESULTS: In 2017-2018, cohorts included: aIIV3, n = 524 223; IIV4, n = 917 609; and HD-IIV3, n = 3 377 860. After adjustment, 2017-2018 rVE of aIIV3 versus IIV4 was 18.2 (95% confidence interval [CI], 15.8-20.5); aIIV3 vs. HD-IIV3 was 7.7 (95% CI, 2.3-12.8). In 2018-2019, cohorts included: aIIV3, n = 1 031 145; IIV4, n = 915 380; HD-IIV3, n = 3 809 601, with adjusted rVEs of aIIV3 versus IIV4 of 27.8 (95% CI, 25.7-29.9) and vs. HD-IIV3 of 6.9 (95% CI, 3.1-10.6). CONCLUSION: In the 2017-2018 and 2018-2019 influenza seasons in the United States, aIIV3 demonstrated greater reduction in influenza-related medical encounters than IIV4 and HD-IIV3 in adults ≥65 years.

Relative Effectiveness of the Cell-Cultured Quadrivalent Influenza Vaccine Compared to Standard, Egg-derived Quadrivalent Influenza Vaccines in Preventing Influenza-like Illness in 2017-2018.

BACKGROUND: Influenza antigens may undergo adaptive mutations during egg-based vaccine production. In the 2017-2018 influenza season, quadrivalent, inactivated cell-derived influenza vaccine (ccIIV4) vaccine was produced using A(H3N2) seed virus propagated exclusively in cell culture, thus lacking egg adaptive changes. This United States study estimated relative vaccine effectiveness (rVE) of ccIIV4 vs egg-derived quadrivalent vaccines (egg-derived IIV4) for that season. METHODS: Vaccination, outcome, and covariate data were ascertained retrospectively from a electronic medical record (EMR) dataset and analyzed. The study cohort included patients ≥ 4 years of age. rVE was estimated against influenza-like illness (ILI) using diagnostic International Classification of Diseases, Ninth or Tenth Revision codes. The adjusted odds ratios used to derive rVE estimates were estimated from multivariable logistic regression models adjusted for age, sex, race/ethnicity, geographic region, and health status. RESULTS: Overall, 92 187 individuals had a primary care EMR record of ccIIV4 and 1 261 675 had a record of egg-derived IIV4. In the ccIIV4 group, 1705 narrowly defined ILI events occurred, and 25 645 occurred in the standard egg-derived IIV4 group. Crude rVE was 9.2% (95% confidence interval [CI], 4.6%-13.6%). When adjusted for age, sex, health status, comorbidities, and geographic region, the estimated rVE changed to 36.2% (95% CI, 26.1%-44.9%). CONCLUSIONS: ccIIV4, derived from A(H3N2) seed virus propagated exclusively in cell culture, was more effective than egg-derived IIV4 in preventing ILI during the 2017-2018 influenza season. This result suggests that cell-derived influenza vaccines may have greater effectiveness than standard egg-derived vaccines.

Comparison of COVID-19 and Influenza-Related Outcomes in the United States during Fall-Winter 2022-2023: A Cross-Sectional Retrospective Study.

Influenza and COVID-19 contribute significantly to the infectious disease burden during the respiratory season, but their relative burden remains unknown. This study characterizes the frequency and severity of medically attended COVID-19 and influenza during the peak of the 2022-2023 influenza season in the pediatric, adult, and older adult populations and characterizes the prevalence of underlying conditions among patients hospitalized with COVID-19. This cross-sectional analysis included individuals in the Veradigm EHR Database linked to Komodo claims data with a medical encounter between 1 October 2022 and 31 March 2023 (study period). Patients with medical encounters were identified with a diagnosis of COVID-19 or influenza during the study period and stratified based on the highest level of care received with that diagnosis. Among 23,526,196 individuals, there were more COVID-19-related medical encounters than influenza-related encounters, overall and by outcome. Hospitalizations with COVID-19 were more common than hospitalizations with influenza overall (incidence ratio = 4.6) and in all age groups. Nearly all adults hospitalized with COVID-19 had at least one underlying medical condition, but 37.1% of 0-5-year-olds and 25.0% of 6-17-year-olds had no underlying medical conditions. COVID-19 was associated greater burden than influenza during the peak of the 2022-2023 influenza season.

Real-World Effectiveness of a Third Dose of mRNA-1273 Versus BNT162b2 on Inpatient and Medically Attended COVID-19 Among Immunocompromised US Adults.

INTRODUCTION: Recent data have shown elevated infection rates in several subpopulations at risk of SARS-CoV-2 infection and COVID-19, including immunocompromised (IC) individuals. Previous research suggests that IC persons have reduced risks of hospitalization and medically attended COVID-19 with two doses of mRNA-1273 (SpikeVax; Moderna) compared to two doses of BNT162b2 (Comirnaty; Pfizer/BioNTech). The main objective of this retrospective cohort study was to compare real-world effectiveness of third doses of mRNA-1273 versus BNT162b2 at multiple time points on occurrence of COVID-19 hospitalization and medically attended COVID-19 among IC adults in the United States (US). METHODS: This retrospective, observational comparative effectiveness study identified patients from the US HealthVerity database from December 11, 2020, through August 31, 2022. Medically attended SARS-CoV-2 infections and hospitalizations were assessed following a three-dose mRNA-1273 versus BNT162b2 regimen. Inverse probability weighting was applied to balance baseline confounders between vaccine groups. Relative risk (RR) and risk difference were calculated for subgroup and sensitivity analyses using a non-parametric method. RESULTS: In propensity score-adjusted analyses, receiving mRNA-1273 vs. BNT162b2 as third dose was associated with 32.4% (relative risk 0.676; 95% confidence interval 0.506-0.887), 29.3% (0.707; 0.573-0.858), and 23.4% (0.766; 0.626-0.927) lower risk of COVID-19 hospitalization after 90, 180, and 270 days, respectively. Corresponding reductions in medically attended COVID-19 were 8.4% (0.916; 0.860-0.976), 6.4% (0.936; 0.895-0.978), and 2.4% (0.976; 0.935-1.017), respectively. CONCLUSIONS: Our findings suggest a third dose of mRNA-1273 is more effective than a third dose of BNT162b2 in preventing COVID-19 hospitalization and breakthrough medically attended COVID-19 among IC adults in the US.

Relative Effectiveness of BNT162b2, mRNA-1273, and Ad26.COV2.S Vaccines and Homologous Boosting in Preventing COVID-19 in Adults in the US.

Background: Few head-to-head comparisons have been performed on the real-world effectiveness of coronavirus disease 2019 (COVID-19) booster vaccines. We evaluated the relative effectiveness (rVE) of a primary series of mRNA-1273 vs BNT162b2 and Ad26.COV2.S and a homologous mRNA booster against any medically attended, outpatient, and hospitalized COVID-19. Methods: A data set linking primary care electronic medical records with medical claims data was used for this retrospective cohort study of US patients age ≥18 years vaccinated with a primary series between February and October 2021 (Part 1) and a homologous mRNA booster between October 2021 and January 2022 (Part 2). Adjusted hazard ratios (HRs) were derived from 1:1 matching adjusted across potential covariates. rVE was (1 - HRadjusted) × 100. Additional analysis was performed across regions and age groups. Results: Following adjustment, Part 1 rVE for mRNA-1273 vs BNT162b2 was 23% (95% CI, 22%-25%), 23% (95% CI, 22%-25%), and 19% (95% CI, 14%-24%), while the rVE for mRNA-1273 vs Ad26.COV2.S was 50% (95% CI, 48%-51%), 50% (95% CI, 48%-52%), and 57% (95% CI, 53%-61%) against any medically attended, outpatient, and hospitalized COVID-19, respectively. The adjusted rVE in Part 2 for mRNA-1273 vs BNT162b2 was 14% (95% CI, 10%-18%), 13% (95% CI, 8%-17%), and 19% (95% CI, 1%-34%) against any medically attended, outpatient, and hospitalized COVID-19, respectively. rVE against medically attended COVID-19 was higher in adults age ≥65 years (35%; 95% CI, 24%-47%) than in those age 18-64 years (13%; 95% CI, 9%-17%) after the booster. Conclusions: In this study, mRNA-1273 was more effective than BNT162b2 or Ad26.COV2.S following a primary series during the Delta-dominant period and more effective than BNT162b2 as a booster during the Omicron-dominant period.

Comparative Effectiveness of Bivalent (Original/Omicron BA.4/BA.5) COVID-19 Vaccines in Adults.

The emergence of Omicron variants coincided with declining vaccine-induced protection against SARS-CoV-2. Two bivalent mRNA vaccines, mRNA-1273.222 (Moderna) and BNT162b2 Bivalent (Pfizer-BioNTech), were developed to provide greater protection against the predominate circulating variants by including mRNA that encodes both the ancestral (original) strain and BA.4/BA.5. We estimated their relative vaccine effectiveness (rVE) in preventing COVID-19-related outcomes in the US using a nationwide dataset linking primary care electronic health records and pharmacy/medical claims data. The study population (aged ≥18 years) received either vaccine between 31 August 2022 and 28 February 2023. We used propensity score weighting to adjust for baseline differences between groups. We estimated the rVE against COVID-19-related hospitalizations (primary outcome) and outpatient visits (secondary) for 1,034,538 mRNA-1273.222 and 1,670,666 BNT162b2 Bivalent vaccine recipients, with an adjusted rVE of 9.8% (95% confidence interval: 2.6-16.4%) and 5.1% (95% CI: 3.2-6.9%), respectively, for mRNA-1273.222 versus BNT162b2 Bivalent. The incremental relative effectiveness was greater among adults ≥ 65; the rVE against COVID-19-related hospitalizations and outpatient visits in these patients was 13.5% (95% CI: 5.5-20.8%) and 10.7% (8.2-13.1%), respectively. Overall, we found greater effectiveness of mRNA-1273.222 compared with the BNT162b2 Bivalent vaccine in preventing COVID-19-related hospitalizations and outpatient visits, with increased benefits in older adults.

The psychosocial impact of an abnormal cervical smear result.

BACKGROUND: Data on the impact of abnormal cervical smear results on health-related quality of life (HrQoL) are scarce. We aimed to (i) prospectively assess the HrQoL of women who were informed of an abnormal smear result; (ii) identify predictors of greater negative psychosocial impact of an abnormal result; and (iii) prospectively estimate the quality-adjusted life-years (QALYs) lost following an abnormal result. METHODS: Between 08/2006 and 08/2008, 492 women with an abnormal result and 460 women with a normal result, frequency matched for age and clinic, were recruited across Canada. HrQoL was measured at recruitment and 4 and 12 weeks later with the EuroQol, Short Form-12, short Spielberg State-Trait Anxiety Inventory (STAI) and HPV Impact Profile. Three blocks of potential predictors of higher psychosocial impact were tested by hierarchical modeling: (i) socio-demographics; (ii) sexual activity; and (iii) smear result severity, communication, and understanding. RESULTS: Receiving an abnormal result significantly increased anxiety (STAI mean difference between both groups = 8.3). Initial anxiety decreased over time for the majority of women. However, 35% of women had clinically meaningful anxiety at 12 weeks (i.e. STAI scores ≥0.5 standard deviation of the controls). These women reported a lower socio-economic level, did not completely understand the information about their result and perceived themselves at higher risk of cancer. QALY lost following an abnormal result were between 0.007 and 0.009. CONCLUSIONS: Receiving an abnormal smear has a statistically significant and clinically meaningful negative impact on mental health. However, this negative impact subsides after 12 weeks for the majority of women.

Integrating Electronic Medical Records and Claims Data for Influenza Vaccine Research.

Real-world evidence (RWE) increasingly informs public health and healthcare decisions worldwide. A large database has been created ("Integrated Dataset") that integrates primary care electronic medical records with pharmacy and medical claims data on >123 million US patients since 2014. This article describes the components of the Integrated Dataset and evaluates its representativeness to the US population and its potential use in evaluating influenza vaccine effectiveness. Representativeness to the US population (2014−2019) was evaluated by comparison with demographic information from the 2019 US census and the National Ambulatory Medical Care Survey (NAMCS). Variables included in the Integrated Dataset were evaluated against World Health Organization (WHO) defined key and non-critical variables for evaluating influenza vaccine performance. The Integrated Dataset contains a variety of information, including demographic data, patient medical history, diagnoses, immunizations, and prescriptions. Distributions of most age categories and sex were comparable with the US Census and NAMCS populations. The Integrated Dataset was less diverse by race and ethnicity. Additionally, WHO key and non-critical variables for the estimation of influenza vaccine effectiveness are available in the Integrated Dataset. In summary, the Integrated Dataset is generally representative of the US population and contains key variables for the assessment of influenza vaccine effectiveness.

Relative Effectiveness of MF59 Adjuvanted Trivalent Influenza Vaccine vs Nonadjuvanted Vaccines During the 2019-2020 Influenza Season.

Background: Age-related immunosenescence may impair the immune response to vaccination in older adults. Adjuvanted influenza vaccines are designed to overcome immune senescence in older adults. This study estimated the relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aIIV3) vs egg-derived quadrivalent inactivated influenza vaccine (IIV4e) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) in preventing influenza-related medical encounters in the 2019-2020 US season. Methods: This retrospective cohort study used electronic medical records linked to pharmacy and medical claims data. The study population included adults age ≥65 years with a record of aIIV3, IIV4e, or HD-IIV3 vaccination. A doubly robust inverse probability of treatment weighting model was used to derive adjusted odds ratios (ORs). rVE was calculated by (1 - ORadjusted)*100 and was determined overall and separately for age subgroups. An exploratory analysis evaluated the outcome separately in inpatient and outpatient settings. Results: Subjects received aIIV3 (n = 936 508), IIV3e (n = 651 034), and HD-IIV3 (n = 1 813 819), and influenza-related medical encounters were recorded in 0.5%, 0.9%, and 0.7% of each cohort, respectively. Overall, the rVE of aIIV3 was 27.5% (95% CI, 24.4% to 30.5%) vs IIV4e and 13.9% (95% CI, 10.7% to 17.0%) vs HD-IIV3. aIIV3 had a more favorable rVE in inpatient and outpatient settings. Findings remained consistent across age subgroups and during alternative seasonal dates. Conclusions: Adults age ≥65 years vaccinated with aIIV3 had fewer influenza-related medical encounters compared with IIV4e or HD-IIV3 during the 2019-2020 US influenza season.

Relative Effectiveness of Cell-based Versus Egg-based Quadrivalent Influenza Vaccines in Children and Adolescents in the United States During the 2019-2020 Influenza Season.

BACKGROUND: Egg-based influenza vaccine production can lead to the accumulation of mutations that affect antigenicity. The mammalian cell-based inactivated quadrivalent influenza vaccine (IIV4c) may improve effectiveness compared with egg-based vaccines. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus egg-based inactivated quadrivalent influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRME) among children and adolescents during the 2019-2020 US influenza season. METHODS: This retrospective cohort study used a dataset linking primary and specialty care electronic medical records with medical and pharmacy claims data from US residents 4 through 17 years of age vaccinated with IIV4c or IIV4e during the 2019-2020 influenza season. Odds ratios (ORs) were derived from a doubly robust inverse probability of treatment-weighted approach adjusting for age, sex, race, ethnicity, region, index week, health status and two proxy variables for healthcare accessibility and use. Adjusted rVE was estimated by (1-OR adjusted )*100, and an exploratory analysis evaluated IRMEs separately for outpatient and inpatient settings. RESULTS: The final study cohort included 60,480 (IIV4c) and 1,240,990 (IIV4e) vaccine recipients. Fewer IRMEs were reported in subjects vaccinated with IIV4c than IIV4e. The rVE for IIV4c versus IIV4e was 12.2% [95% confidence interval (CI): 7.5-16.6] for any IRME and 14.3% (9.3-19.0) for outpatient IRMEs. Inpatient IRMEs were much less frequent, and effectiveness estimates were around the null. CONCLUSIONS: Fewer IRMEs occurred in pediatric subjects vaccinated with IIV4c versus IIV4e. These results support the greater effectiveness of IIV4c over IIV4e in this population during the 2019-2020 US influenza season.

Relative Effectiveness of Cell-Based Versus Egg-Based Quadrivalent Influenza Vaccines in Adults During the 2019-2020 Influenza Season in the United States.

Background: Mutations occurring during egg-based influenza vaccine production may affect vaccine effectiveness. The mammalian cell-based quadrivalent inactivated influenza vaccine (IIV4c) demonstrated improved protection relative to egg-based vaccines in prior seasons. This study estimated the relative vaccine effectiveness (rVE) of IIV4c versus standard-dose egg-based quadrivalent inactivated influenza vaccine (IIV4e) in preventing influenza-related medical encounters (IRMEs) in the 2019-2020 US influenza season. Methods: This retrospective cohort study was conducted using a dataset linking electronic medical records with medical and pharmacy claims data among individuals ≥18 years vaccinated with IIV4c or IIV4e during 2019-2020. A doubly robust inverse probability of treatment weighting model was used to obtain odds ratios (ORs) adjusted for age, sex, race, ethnicity, region, vaccination week, health status, frailty, and baseline healthcare resource utilization. rVE was calculated by (1 - OR) × 100. An exploratory analysis evaluated IRMEs in inpatient and outpatient settings separately. Results: The final study cohort included 1 499 215 IIV4c and 4 126 263 IIV4e recipients ≥18 years of age. Fewer IRMEs were reported in individuals with recorded IIV4c versus IIV4e. The rVE for IIV4c versus IIIV4e for any IRME was 9.5% (95% confidence interval [CI], 7.9%-11.1%). Inpatient and outpatient rVEs were 5.7% (95% CI, 2.1%-9.2%) and 11.4% (95% CI, 9.5%-13.3%), respectively. In age subgroup analyses, rVEs favored IIV4c except in adults aged ≥65 years. Conclusions: Adults vaccinated with IIV4c had a lower risk of IRMEs versus IIV4e recipients in the 2019-2020 US influenza season. These results support IIV4c as a potentially more effective public health measure against influenza than egg-based vaccines.

Continuing Medical Education Improves Physician Communication Skills and Increases Likelihood of Pediatric Vaccination: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-II.

This study evaluated the impact of a continuing medical education (CME) program that emphasized actionable information, motivation to act, and skills to strengthen physician recommendations for seasonal influenza vaccination in children 6 through 23 months of age for whom influenza immunization rates are suboptimal. Physicians were randomly assigned to an accredited CME program or to no CME. Participants completed pre- and post-study questionnaires. Influenza immunization rates were compared between groups. A total of 33 physicians in the CME group and 35 in the control group documented 292 and 322 healthy baby visits, respectively. Significantly more parents immunized their children against influenza after interacting with CME-trained physicians than those with no CME training (52.9% vs. 40.7%; p = 0.007). The odds ratio for vaccination after visits with CME-trained physicians was 1.52 (95% confidence interval 1.09 to 2.12; p = 0.014), which was unaffected by the socioeconomic status of parents. Parents who discussed influenza vaccination with CME-trained physicians were 20% more likely to choose an approved but publicly unfunded adjuvanted pediatric influenza vaccine. The percentages of physicians reporting the highest levels of knowledge, ability, and confidence doubled or tripled after the CME intervention. Significantly more parents immunized very young children after interacting with physicians who had undergone CME training.

Clinicians Are Not Able to Infer Parental Intentions to Vaccinate Infants with a Seasonal Influenza Vaccine, and Perhaps They Should Not Try: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-IV.

This prospective cohort survey evaluated the concordance of clinicians' perceptions of parental intentions and parents' actual intentions to vaccinate their infants against influenza. During a routine healthy baby visit, clinicians provided parents with information about influenza, children's vulnerability to influenza, and nonadjuvanted and adjuvanted trivalent influenza vaccines (TIV and aTIV, respectively). Before and after the clinician−parent interaction, parents were surveyed about their attitudes, their perceptions of support from significant others, and the intention to vaccinate their infant with aTIV. Clinicians were asked about their perception of parents' intentions to choose aTIV for their children. These assessments included 24 clinicians at 15 community practices and nine public health clinics, and 207 parents. The correlation coefficients of the clinicians' assessment of parents' intention to vaccinate were 0.483 (p < 0.001) if the vaccine was presented as free of cost, 0.266 (p < 0.001) if the cost was $25, and 0.146 (p = 0.036) if the cost was $50, accounting for 23%, 7%, and 2% of the variance in parental intentions, respectively. The clinicians were poor at predicting parental intentions to immunize, particularly when cost was involved. Information on vaccine options and influenza infection should be provided for every eligible patient to allow parents to determine if the vaccine is appropriate for their child.

Parental Attitudes and Perceptions of Support after Brief Clinician Intervention Predict Intentions to Accept the Adjuvanted Seasonal Influenza Vaccination: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-I.

Adjuvanted trivalent influenza vaccine (aTIV) provides enhanced protection against seasonal influenza in children compared with nonadjuvanted trivalent influenza vaccine (TIV). This prospective cohort study assessed parental attitudes, beliefs, and intentions to vaccinate their infants aged 6-23 months with aTIV. Parents were surveyed before and after routine healthy baby visits, and post clinician interaction results were analyzed using multivariable logistic regression. Physicians at 15 community practice clinics and nurses at 3 public health clinics participated; 207 parents were surveyed. After clinician consultation, most parents considered immunization with aTIV to be safe (72.9%), effective (69.6%), and important (69.0%); most perceived support for vaccination from significant others (62.8%) and clinicians (81.6%); and 66.6% intended to vaccinate their infant with aTIV. Parental attitudes toward vaccinating their infant with aTIV were strongly correlated with perceptions of vaccine safety, efficacy, and importance, and these represented the strongest influence on intentions to vaccinate (odds ratio (OR) 79.25; 95% confidence interval (CI) 6.05-1037.50). Parental intentions were further influenced by perceived strength of clinician recommendation (OR 4.55, 95% CI 1.38-15.06) and social support for vaccination (OR 3.46, 95% CI 0.50-24.13). These findings may inform clinician approaches to parental education to ensure optimal seasonal pediatric influenza vaccination.

Understanding the Impact of Approved but Unfunded Vaccine Status on Parental Acceptance of an Adjuvanted Seasonal Influenza Vaccine for Infants: Results from the Pediatric Influenza Vaccination Optimization Trial (PIVOT)-III.

The adjuvanted trivalent influenza vaccine (aTIV) provides enhanced protection against influenza for infants but is not publicly funded (NPF). The objective of this prospective cohort study of parents with children 6 through 23 months of age was to understand how NPF status influences parental perceptions of approved but unfunded vaccines and their intentions to vaccinate. At healthy baby visits, clinicians provided parents with information about influenza and vaccination. Before and after these interactions, a research nurse assessed parents' intentions to vaccinate their children and their beliefs about the safety, efficacy, and necessity of vaccinating their children with aTIV in both publicly funded (PF) and NPF settings. Overall, 15 community practice clinics (n = 15 physicians) and nine public health clinics (n = 9 nurses) recruited 207 parents. The percentage of parents intending to immunize their children with aTIV decreased from 72% (vaccine PF, free of charge), to 42% (NPF, $25 per dose), to 27% (NPF, $50 per dose). Funding status strongly influenced whether parents perceived immunization with aTIV to be necessary, safe, and effective. Information on influenza and influenza vaccines should be provided to parents routinely to allow for well-informed decisions on the suitability of specific influenza vaccines for their child.

Loss of quality of life associated with genital warts: baseline analyses from a prospective study.

OBJECTIVE: The quadrivalent human papillomavirus (HPV) vaccine is effective against HPV types responsible for 90% of anogenital warts. This study estimated the quality of life lost to genital warts using the EQ-5D, a generic instrument widely used for applications in economic analyses. The findings are described in terms that are more specific to individuals with genital warts using psychosocial questions adapted from the HPV impact profile, a measure developed for HPV-related conditions. METHODS: Between September 2006 and February 2008, 42 physicians across Canada recruited 330 consenting patients 18 years and older with genital warts, either at the first or follow-up visit for an initial or recurrent episode. The quality of life lost associated with genital warts was estimated by the difference between participants' EQ-5D scores and age and gender-specific population norms. RESULTS: The study questionnaire was self-completed by 270 participants who were aged 31.5 years (SD 10.4) on average. The majority of participants were women (53.3%), heterosexual (93.5%) and in a stable relationship (66.0%). Genital warts were associated with detriments in the EQ-5D domains of anxiety/depression, pain/discomfort and usual activities. The absolute difference in the EQ-5D utility score and the EQ-VAS health status between genital warts patients and population norms was 9.9 (95% CI 7.3 to 12.5) and 6.0 (95% CI 4.1 to 7.9) percentage points, respectively. These results did not vary significantly according to patient age, gender, time since first episode or number of episodes. CONCLUSION: The results suggest that genital warts negatively affect the wellbeing of men and women as reflected by poorer quality of life scores compared with population norms.

The impact of anogenital warts on health-related quality of life: a 6-month prospective study.

BACKGROUND: The burden of anogenital warts will be a determining factor when making decisions about the type of human papillomavirus (HPV) vaccine to be used (bivalent or quadrivalent) and whether to vaccinate males. We conducted a multicenter prospective study to (1) describe the impact of anogenital warts on quality of life and (2) estimate the quality-adjusted life-years (QALYs) lost due to anogenital warts. METHODS: Between September 2006 and February 2008, 272 patients with a first or recurrent episode of anogenital warts were recruited from the clinical practices of 42 physicians across Canada. Quality of life was measured at recruitment, and 2 and 6 months later with the EuroQol, Short Form-12, short Spielberg State-Trait Anxiety Inventory, and HPV impact profile. The duration of an episode and QALYs lost due to anogenital warts were estimated among 51 incident cases recruited within 90 days of disease onset. RESULTS: Anogenital warts had a significant impact on the quality of life. This negative impact was similar for first and recurrent episodes, and lasted as long as lesions persisted. Anogenital warts had the greatest negative impact on usual activities, pain/discomfort, and anxiety/depression, and on self-image, sexual activity, and partner issues and possible transmission. The median duration of a first anogenital wart episode amongst incident cases was 125 days and resulted in QALYs lost of 0.017 to 0.041, which is equivalent to 6 to 15 days of healthy life lost. CONCLUSIONS: The burden of anogenital warts is substantial and should be considered by physicians and public health officials when making recommendations about HPV vaccination..

Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications.

MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) elicit an enhanced immune response in older adults compared to standard, quadrivalent inactivated influenza vaccines (IIV4). We sought to determine the relative vaccine effectiveness (rVE) of aIIV3 versus IIV4 and HD-IIV3 in preventing influenza-related medical encounters in this retrospective cohort study involving adults ≥65 years with ≥1 health condition during the 2017-2018 and 2018-2019 influenza seasons. Data were obtained from primary and specialty care electronic medical records linked with pharmacy and medical claims. Adjusted odds ratios (OR) were derived from an inverse probability of treatment-weighted sample adjusted for age, sex, race, ethnicity, geographic region, vaccination week, and health status. rVE was determined using the formula (% rVE = 1 - ORadjusted) × 100. Analysis sets included 1,755,420 individuals for the 2017-2018 season and 2,055,012 for the 2018-2019 season. Compared to IIV4, aIIV3 was 7.1% (95% confidence interval 3.3-10.8) and 20.4% (16.2-24.4) more effective at preventing influenza-related medical encounters in the 2017-2018 and 2018-2019 seasons, respectively. Comparable effectiveness was observed with HD-IIV3 across both seasons. Our results support improved effectiveness of aIIV3 vs IIV4 in a vulnerable population of older adults at high risk of influenza and its complications.