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Background This study estimated the relative vaccine effectiveness (rVE) of the MF59-adjuvanted trivalent influenza vaccine (aTIV) versus high-dose trivalent inactivated influenza vaccine (HD-TIV) for prevention of influenza-related medical encounters (IRMEs) during the 2019–2020 United States (US) influenza season stratified by the cumulative number of influenza risk factors. A secondary objective evaluated outpatient IRMEs and influenza- and pneumonia-related hospitalizations. Methods This retrospective cohort study included US adults ≥65 years old vaccinated with aTIV or HD-TIV between 1 August 2019 and 31 January 2020. Electronic health records linked to claims were used to ascertain exposure, covariates, risk factors, and outcomes. Multivariable adjusted odds ratios (ORs) were derived using inverse probability of treatment–weighted samples to calculate rVEs independently for individuals with 0, ≥1, 1–2, or ≥3 risk factors. Results The study included 1 115 725 aTIV and 2 561 718 HD-TIV recipients. For the primary outcome of any IRME, the analysis found comparable effectiveness between aTIV and HD-TIV (rVE, 5.2% [95% confidence interval {CI}, −5.9% to 15.1%]) among those with 0 risk factors, whereas aTIV was more effective than HD-TIV among patients with ≥1, 1–2, or ≥3 risk factors (12.5% [95% CI, 10.0%–15.0%], 18.4% [95% CI, 13.7%–22.9%], and 10.4% [7.4%–13.3%], respectively). The same trends were observed for the secondary outcomes. Conclusions This study demonstrated comparable effectiveness of aTIV and HD-TIV among individuals with no identified risk factors and higher effectiveness of aTIV compared with HD-TIV in preventing any IRMEs, outpatient IRMEs, and influenza- or pneumonia-related hospitalizations among those with at least 1 or multiple high-risk factors in adults ≥65 years old. [ABSTRACT FROM AUTHOR]

Background While studies have evaluated factors influencing the risk of severe influenza outcomes, there is limited evidence on the additive impact of having multiple influenza risk factors and how this varies by age. Methods Patients ≥18 years of age in the United States were evaluated retrospectively in 5 seasonal cohorts during the 2015–2020 influenza seasons. Patient-level electronic medical records linked to pharmacy and medical claims were used to ascertain covariates and outcomes. Multivariable logistic regression models were fitted for the overall population and by age subgroups to evaluate the association of demographic and clinical characteristics with odds of influenza-related medical encounters (ICD-10 codes J09*–J11*). The logistic regression models included sex, race/ethnicity, geographic region, baseline health care resource use, vaccination status, specific high-risk comorbidities, number of influenza risk factors, body mass index, and smoking status. Odds ratios from each of the 5 seasons were summarized via fixed effect meta-analysis. Results Season cohort sizes ranged from 887 260 to 3 628 168 adults. Of all patient characteristics evaluated, an individual's cumulative number of high-risk influenza conditions, as defined per the Centers for Disease Control and Prevention, was the most predictive of an increased probability of having an influenza-related medical encounter overall and across age groups. For adults of any age, odds ratios for influenza hospitalization ranged from 1.8 (95% CI, 1.7–2.0) for 1 risk factor to 6.4 (95% CI, 5.8–7.0) for ≥4 risk factors. Conclusions These results show that a simple measure such as the number of influenza risk factors can be highly informative of an adult's potential for severe influenza outcomes. [ABSTRACT FROM AUTHOR]

Background Influenza vaccine viruses grown in eggs may acquire egg-adaptive mutations that may reduce antigenic similarity between vaccine and circulating influenza viruses and decrease vaccine effectiveness. We compared cell- and egg-based quadrivalent influenza vaccines (QIVc and QIVe, respectively) for preventing test-confirmed influenza over 3 US influenza seasons (2017–2020). Methods Using a retrospective test-negative design, we estimated the relative vaccine effectiveness (rVE) of QIVc vs QIVe among individuals aged 4 to 64 years who had an acute respiratory or febrile illness and were tested for influenza in routine outpatient care. Exposure, outcome, and covariate data were obtained from electronic health records linked to pharmacy and medical claims. Season-specific rVE was estimated by comparing the odds of testing positive for influenza among QIVc vs QIVe recipients. Models were adjusted for age, sex, geographic region, influenza test date, and additional unbalanced covariates. A doubly robust approach was used combining inverse probability of treatment weights with multivariable regression. Results The study included 31 824, 33 388, and 34 398 patients in the 2017–2018, 2018–2019, and 2019–2020 seasons, respectively; ∼10% received QIVc and ∼90% received QIVe. QIVc demonstrated superior effectiveness vs QIVe in prevention of test-confirmed influenza: rVEs were 14.8% (95% CI, 7.0%–22.0%) in 2017–2018, 12.5% (95% CI, 4.7%–19.6%) in 2018–2019, and 10.0% (95% CI, 2.7%–16.7%) in 2019–2020. Conclusions This study demonstrated consistently superior effectiveness of QIVc vs QIVe in preventing test-confirmed influenza over 3 seasons characterized by different circulating viruses and degrees of egg adaptation. [ABSTRACT FROM AUTHOR]

Background: Adults ≥ 65 years of age have suboptimal influenza vaccination responses compared to younger adults due to age‐related immunosenescence. Two vaccines were specifically developed to enhance protection: MF59‐adjuvanted trivalent influenza vaccine (aIIV3) and high‐dose egg‐based trivalent influenza vaccine (HD‐IIV3e). Methods: In a retrospective cohort study conducted using US electronic medical records linked to claims data during the 2019–2020 influenza season, we compared the relative vaccine effectiveness (rVE) of aIIV3 with HD‐IIV3e and a standard‐dose non‐adjuvanted egg‐based quadrivalent inactivated influenza vaccine (IIV4e) for the prevention of cardiorespiratory hospitalizations, including influenza hospitalizations. We evaluated outcomes in the "any" diagnosis position and the "admitting" position on the claim. A doubly robust methodology using inverse probability of treatment weighting and logistic regression was used to adjust for covariate imbalance. rVE was calculated as 100 * (1 − ORadjusted). Results: The study included 4,299,594 adults ≥ 65 years of age who received aIIV3, HD‐IIV3e, or IIV4e. Overall, aIIV3 was associated with lower proportions of cardiorespiratory hospitalizations with diagnoses in any position compared to HD‐IIV3e (rVE = 3.9% [95% CI, 2.7–5.0]) or IIV4e (9.0% [95% CI, 7.7–10.4]). Specifically, aIIV3 was more effective compared with HD‐IIV3e and IIV4e in preventing influenza hospitalizations (HD‐IIV3e: 9.7% [95% CI, 1.9–17.0]; IIV4e: 25.3% [95% CI, 17.7–32.2]). Consistent trends were observed for admitting diagnoses. Conclusion: Relative to both HD‐IIV3e and IIV4e, aIIV3 provided improved protection from cardiorespiratory or influenza hospitalizations. [ABSTRACT FROM AUTHOR]

Purpose To investigate the safety of trivalent seasonal influenza vaccine (TIVc) (Optaflu®), the first cell culture seasonal trivalent influenza vaccine available in Europe. Methods Codes and unstructured text in adult electronic healthcare records (The Health Improvement Network) were searched for a TIVc brand name or batch number and possible outcomes within a 3 month pre- to 6 month post-TIVc exposure study period (2012-2015). The outcomes were severe allergic reactions, Bell's palsy, convulsions, demyelination, paresthesia, noninfectious encephalitis, neuritis (optic and brachial), vasculitis, inflammatory bowel disease, and thrombocytopenia. Risk periods were defined based on biologically plausible time frame postvaccination when an outcome caused by the vaccine might be expected to occur. Possible outcomes were adjudicated against outcome specific case definitions and a date of onset assigned by using electronic and other medical records. Observed (risk period) to expected (outside risk and preexposure periods) rate ratios, postexposure incidence, and plots of time from exposure to outcome were reported. Results Sixteen of 1011 events from 4578 exposures fulfilled a primary case definition and had a date of onset during the study period. Three were in observed time. The observed-to-expected rate ratios were (3.3, 95% CI 0.3, 31.7) for convulsions and (1.5, 95% CI 0.2, 14.9) for thrombocytopenia with 1 outcome each in observed time. There was 1 incident inflammatory bowel disease in observed, but none in expected, time. Conclusion The small sample size restricts interpretation; however, no hypothesis of an increased risk of a study outcome was generated. Adjudication of events against case definitions to reduce misclassification of onset and outcomes allowed use of precise risk periods. [ABSTRACT FROM AUTHOR]

Objectives: This study evaluated relative vaccine effectiveness (rVE) of MF59-adjuvanted trivalent inactivated influenza vaccine (aTIV) vs high-dose trivalent inactivated influenza vaccine (HD-TIV) for prevention of test-confirmed influenza emergency department visits and/or inpatient admissions ("ED/IP") and for IP admissions alone pooled across the 2017-2020 influenza seasons. Exploratory individual season analyses were also performed., Methods: This retrospective test-negative design study included United States (US) adults age ≥65 years vaccinated with aTIV or HD-TIV who presented to an ED or IP setting with acute respiratory or febrile illness during the 2017-2020 influenza seasons. Test-positive cases and test-negative controls were grouped by vaccine received. The rVE of aTIV vs HD-TIV was evaluated using a combination of inverse probability of treatment weighting and logistic regression to adjust for potential confounders., Results: Pooled analyses over the three seasons found no significant differences in the rVE of aTIV vs HD-TIV for prevention of test-confirmed influenza ED/IP (-2.5% [-19.6, 12.2]) visits and admissions or IP admissions alone (-1.6% [-22.5, 15.7]). The exploratory individual season analyses also showed no significant differences., Conclusions: Evidence from the 2017-2020 influenza seasons indicates aTIV and HD-TIV are comparable for prevention of test-confirmed influenza ED/IP visits in US adults age ≥65 years., Competing Interests: Declarations of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: IM, MI, and MH are an employee of CSL Seqirus. IM and MH hold stock in CSL Limited. BC, TB, NW are employees of Optum, which received funding from CSL Seqirus in support of this work. SP received financial support from CSL Seqirus in support of this work., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Purpose: To investigate the safety of trivalent seasonal influenza vaccine (TIVc) (Optaflu ® ), the first cell culture seasonal trivalent influenza vaccine available in Europe., Methods: Codes and unstructured text in adult electronic healthcare records (The Health Improvement Network) were searched for a TIVc brand name or batch number and possible outcomes within a 3 month pre- to 6 month post-TIVc exposure study period (2012-2015). The outcomes were severe allergic reactions, Bell's palsy, convulsions, demyelination, paresthesia, noninfectious encephalitis, neuritis (optic and brachial), vasculitis, inflammatory bowel disease, and thrombocytopenia. Risk periods were defined based on biologically plausible time frame postvaccination when an outcome caused by the vaccine might be expected to occur. Possible outcomes were adjudicated against outcome specific case definitions and a date of onset assigned by using electronic and other medical records. Observed (risk period) to expected (outside risk and preexposure periods) rate ratios, postexposure incidence, and plots of time from exposure to outcome were reported., Results: Sixteen of 1011 events from 4578 exposures fulfilled a primary case definition and had a date of onset during the study period. Three were in observed time. The observed-to-expected rate ratios were (3.3, 95% CI 0.3, 31.7) for convulsions and (1.5, 95% CI 0.2, 14.9) for thrombocytopenia with 1 outcome each in observed time. There was 1 incident inflammatory bowel disease in observed, but none in expected, time., Conclusion: The small sample size restricts interpretation; however, no hypothesis of an increased risk of a study outcome was generated. Adjudication of events against case definitions to reduce misclassification of onset and outcomes allowed use of precise risk periods. KEY POINTS This observational study did not generate a hypothesis of an association between the first cell-culture seasonal influenza vaccination available in the European Union and any of the study outcomes (severe allergic reactions, Bell's palsy, convulsions, demyelination, paresthesia, noninfectious encephalitis, neuritis [optic and brachial], vasculitis, inflammatory bowel disease [IBD], and thrombocytopenia). The small sample size limits interpretation of the results. The review of each possible outcome identified from electronic healthcare records against case definitions was included to minimize misclassification of time and outcomes and allow the use of precise risk-periods in an observed-to-expected within cohort analysis. Plots of time from exposure to outcome were included to assess the risk windows., (Copyright © 2017 John Wiley & Sons, Ltd.)

Background: Several lines of evidence suggest a role of inflammatory processes in Parkinson disease, although it is still unclear whether inflammation is a cause or rather a consequence of neurodegeneration., Methods: In a prospective population-based cohort study among 6,512 participants aged >or=55 years, with repeated in-person examination, we evaluated the association between cumulative use of nonsteroidal anti-inflammatory drugs (NSAIDs) and the risk of Parkinson disease. Complete information on filled prescriptions was available from automated pharmacy records. Data were analyzed by means of Cox proportional hazards regression analysis, adjusted for age, sex, smoking habits and coffee consumption., Results: After an average 9.4 years of follow-up, 88 new cases of Parkinson disease were detected. No association was found between use of NSAIDs and the risk of Parkinson disease (adjusted hazard ratio for any NSAID use, 1.50; 95% confidence interval, 0.95-2.37)., Conclusion: Our findings do not support the hypothesis that NSAIDs might decrease the risk of Parkinson disease., ((c) 2007 S. Karger AG, Basel.)