scholarly journals 25. Relative Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-Based Trivalent High-Dose Influenza Vaccine among U.S. Older Adults during 2019-20 Influenza Season

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S136-S136
Author(s):  
myron J levin ◽  
Victoria Divino ◽  
Stephen I Pelton ◽  
Maarten Postma ◽  
Drishti Shah ◽  
...  

Abstract Background According to the Centers for Disease Control and Prevention (CDC), during the 2019-20 U.S. influenza season, influenza resulted in almost 180,000 hospitalizations and over 13,000 deaths in adults ≥ 65 years. The current study evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, all-cause hospitalizations and hospitalizations/ER visits for cardio-respiratory disease (CRD) among adults ≥65 years for the 2019-20 influenza season. Methods A retrospective cohort analysis of older adults (≥ 65 years) was conducted using IQVIA’s professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, geographic region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. To avoid any influenza outcome misclassification with COVID-19 infection, the study period ended March 7, 2020. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits, all-cause hospitalizations and any hospitalization/ER visit for CRD. An unrelated negative control outcome, urinary tract infection (UTI) hospitalization was included. Results During the 2019-20 influenza season, following IPTW, 798,987 recipients of aTIV and 1,655,979 recipients of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was statistically comparable to TIV-HD for prevention of influenza-related hospitalizations/ER visits (3.1%; 95% CI: -2.8%-8.6%) and all-cause hospitalizations (-0.7%; 95% CI: -1.6%-0.3%). Similar comparable outcomes were found for reduction of any hospitalization/ER visit for CRD (0.9%; 95% CI: 0.0%-1.7%). No treatment effect was identified for the negative control outcome. Conclusion aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits, all-cause hospitalizations and hospitalizations/ER visits for CRD. Disclosures myron J. levin, MD, GSK group of companies (Employee, Research Grant or Support) Victoria Divino, PhD, Seqirus (Consultant) Stephen I. Pelton, MD, Seqirus (Consultant) Maarten Postma, Dr., Seqirus (Consultant) Drishti Shah, PhD, Seqirus (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus (Employee) Mitchell DeKoven, PhD, Seqirus (Consultant)

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S3-S3
Author(s):  
Stephen I Pelton ◽  
Maarten Postma ◽  
Victoria Divino ◽  
Drishti Shah ◽  
Joaquin F Mould-Quevedo ◽  
...  

Abstract Background In the 2018–19 influenza season, influenza resulted in almost 280,000 hospitalizations and over 25,000 deaths in U.S. adults > 65 years. This study aimed to evaluate the relative vaccine effectiveness (rVE) of adjuvant trivalent influenza vaccine (aTIV) compared to high-dose trivalent influenza vaccine (TIV-HD), against influenza-related hospitalizations/emergency room (ER) visits, office visits and hospitalization/ER visit for cardio-respiratory disease (CRD) among older adults for the 2018–19 flu season. Methods A retrospective cohort analysis of older adults (> 65 years) was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index (CCI), comorbidities, indicators of frail health status, and pre-index hospitalization rates. Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE against influenza-related hospitalizations/ER visits and office visits and any hospitalization/ER visit for CRD (based on diagnoses codes). An unrelated outcome, urinary tract infection (UTI) hospitalization, was assessed. Results During 2018–19 flu season, following IPTW analyses, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. After IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (6.6%; 95% CI: 2.8%-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) for prevention of influenza-related hospitalizations/ER visits but more effective than TIV-HD (2.6%; 95% CI: 2.0%-3.2%) in reducing hospitalizations/ER visits for CRD. No treatment effect was identified for control condition (UTI hospitalization). Conclusion In adjusted analyses, aTIV reduced influenza-related office visits and CRD hospitalizations/ER visits compared to TIV-HD. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Maarten Postma, Dr., IQVIA (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)


Author(s):  
Constantina Boikos ◽  
Lauren Fischer ◽  
Dan O’Brien ◽  
Joe Vasey ◽  
Gregg C Sylvester ◽  
...  

Abstract 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.


Vaccines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1146
Author(s):  
Myron J. Levin ◽  
Victoria Divino ◽  
Drishti Shah ◽  
Mitch DeKoven ◽  
Joaquin Mould-Quevedo ◽  
...  

The burden of influenza is disproportionally higher among older adults. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent (aIIV3) compared to high-dose trivalent influenza vaccine (HD-IIV3e) against influenza and cardio-respiratory disease (CRD)-related hospitalizations/ER visits among adults ≥65 years during the 2019–2020 influenza season. Economic outcomes were also compared. A retrospective cohort analysis was conducted using prescription, professional fee claims, and hospital data. Inverse probability of treatment weighting (IPTW) was used to adjust for confounding. IPTW-adjusted Poisson regression was used to evaluate the adjusted rVE of aIIV3 versus HD-IIV3e. All-cause and influenza-related healthcare resource utilization (HCRU) and costs were examined post-IPTW. Recycled predictions from generalized linear models were used to estimate adjusted costs. Adjusted analysis showed that aIIV3 (n = 798,987) was similarly effective compared to HD-IIV3e (n = 1,655,979) in preventing influenza-related hospitalizations/ER visits (rVE 3.1%; 95% CI: −2.8%; 8.6%), hospitalizations due to any cause (−0.7%; 95% CI: −1.6%; 0.3%), and any CRD-related hospitalization/ER visit (0.9%; 95% CI: 0.01%; 1.7%). Adjusted HCRU and annualized costs were also statistically insignificant between the two cohorts. The adjusted clinical and economic outcomes evaluated in this study were comparable between aIIV3 and HD-IIV3e during the 2019–2020 influenza season.


Vaccines ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 446
Author(s):  
Stephen I. Pelton ◽  
Victoria Divino ◽  
Drishti Shah ◽  
Joaquin Mould-Quevedo ◽  
Mitch DeKoven ◽  
...  

The influenza-related disease burden is highest among the elderly. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to other egg-based influenza vaccines (high-dose trivalent (TIV-HD), quadrivalent (QIVe-SD), and standard-dose trivalent (TIVe-SD)) against influenza-related and cardio-respiratory events among subjects aged ≥65 years for the 2017–2018 influenza season. This retrospective cohort analysis used prescription claims, professional fee claims, and hospital charge master data. Influenza-related hospitalizations/ER visits and office visits and cardio-respiratory events were assessed post-vaccination. Inverse probability of treatment weighting (IPTW) and Poisson regression were used to evaluate the adjusted rVE of aTIV compared to other vaccines. In an economic analysis, annualized follow-up costs were compared between aTIV and TIV-HD. The study was composed of 234,313 aTIV, 1,269,855 TIV-HD, 212,287 QIVe-SD, and 106,491 TIVe-SD recipients. aTIV was more effective in reducing influenza-related office visits and other respiratory-related hospitalizations/ER visits compared to the other vaccines. For influenza-related hospitalizations/ER visits, aTIV was associated with a significantly higher rVE compared to QIVe-SD and TIVe-SD and was comparable to TIV-HD. aTIV was also associated with a significantly higher rVE compared to TIVe-SD against hospitalizations/ER visits related to pneumonia and asthma/COPD/bronchial events. aTIV and TIV-HD were associated with comparable annualized all-cause and influenza-related costs. Adjusted analyses demonstrated a significant benefit of aTIV against influenza- and respiratory-related events compared to the other egg-based vaccines.


2020 ◽  
Vol 71 (10) ◽  
pp. e665-e671 ◽  
Author(s):  
Constantina Boikos ◽  
Gregg C Sylvester ◽  
John S Sampalis ◽  
James A Mansi

Abstract 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.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S10-S10
Author(s):  
Joshua Doyle ◽  
Lauren Beacham ◽  
Elif Alyanak ◽  
Manjusha Gaglani ◽  
Emily T Martin ◽  
...  

Abstract Background Seasonal influenza causes substantial morbidity and mortality, and older adults are disproportionately affected. Newer vaccines have been developed for use in people 65 years and older, including a trivalent inactivated vaccine with a 4-fold higher dose of antigen (IIV-HD). In recent years, the use of IIV-HD has increased sufficiently to evaluate its effectiveness compared with standard-dose inactivated influenza vaccines (IIV-SD). Methods Hospitalized patients with acute respiratory illness were enrolled in an observational vaccine effectiveness study at 8 hospitals in 4 states participating in the United States Hospitalized Adult Influenza Vaccine Effectiveness Network during the 2015–2016 and 2016–2017 influenza seasons. Predominant influenza A virus subtypes were H1N1 and H3N2, respectively, during these seasons. All enrolled patients were tested for influenza virus with polymerase chain reaction. Receipt and type of influenza vaccine was determined from electronic records and chart review. Odds of laboratory-confirmed influenza were compared among vaccinated and unvaccinated patients. Relative odds of laboratory-confirmed influenza were determined for patients who received IIV-HD or IIV-SD, and adjusted for potential confounding variables via logistic regression. Results Among 1,744 enrolled patients aged ≥ 65 years, 1,105 (63%) were vaccinated; among those vaccinated, 621 (56%) received IIV-HD and 484 (44%) received IIV-SD. Overall, 315 (18%) tested positive for influenza, including 97 (6%) who received IIV-HD, 86 (5%) who received IIV-SD, and 132 (8%) who were unvaccinated. Controlling for age, race, sex, enrollment site, date of illness, index of comorbidity, and influenza season, the adjusted odds of influenza among patients vaccinated with IIV-HD vs. IIV-SD were 0.72 (P = 0.06, 95% CI: 0.52 to 1.01). Conclusion Comparison of high-dose vs. standard-dose vaccine effectiveness during 2 recent influenza seasons (1 H1N1 and 1 H3N2-predominant) suggested relative benefit (nonsignificant) of high-dose influenza vaccine in protecting against influenza-associated hospitalization among persons aged 65 years and older; additional years of data are needed to confirm this finding. Disclosures H. K. Talbot, sanofi pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S38-S39
Author(s):  
Maarten Postma ◽  
Stephen I Pelton ◽  
Victoria Divino ◽  
Joaquin F Mould-Quevedo ◽  
Drishti Shah ◽  
...  

Abstract Background Influenza generates a substantial economic burden ($3.2B in the U.S. annually) due to direct medical costs such as physician office visits or hospitalizations, especially among the elderly. Recent published literature for the 2018–19 influenza season has demonstrated similar clinical effectiveness between adjuvanted trivalent influenza vaccine (aTIV) and trivalent high dose influenza vaccine (TIV-HD). This research aimed to assess the annualized mean all-cause and influenza-related healthcare costs among subjects 65+ years vaccinated with aTIV or TIV-HD during the 2018–19 influenza season. Methods A retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. Baseline characteristics included age, gender, payer type, region, Charlson Comorbidity Index, comorbidities, indicators of frail health status, and pre-index hospitalization rates. Treatment selection bias was adjusted through 1:1 propensity score matching (PSM). Economic outcomes included annualized mean all-cause costs and influenza-related costs, which comprised influenza-related hospitalizations, emergency room (ER) visits, and physician office visits costs. Mean costs were compared using paired t-test. Adjusted analyses were conducted using generalized estimating equation (GEE) models, with two-part models for influenza-related costs. With the GEEs, adjustment for outliers (99th percentile) were addressed and predicted healthcare costs were obtained through bootstrapping (500 replications). Results During the 2018–19 influenza season, the PSM sample comprised 561,243 recipients of aTIV and 561,243 recipients of TIV-HD. Following GEE adjustment, predicted mean annualized all-cause and influenza-related costs per patient were statistically similar between aTIV and TIV-HD (US$9,676 vs. US$9,625 and US$23.75 vs. US$21.79, respectively). Both aTIV and TIV-HD were comparable in terms of predicted mean annualized costs for influenza-related hospitalizations (US$20.28 vs. US$18.13) and influenza-related office visits (US$1.29 vs. US$1.34). Conclusion In adjusted analyses, total all-cause and influenza-related healthcare costs were comparable among elderly subjects vaccinated with either aTIV or TIV-HD. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant) Girishanthy Krishnarajah, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder)


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S29-S30
Author(s):  
Maarten Postma ◽  
Stephen I Pelton ◽  
Victoria Divino ◽  
Joaquin F Mould-Quevedo ◽  
Drishti Shah ◽  
...  

Abstract Background Influenza vaccine effectiveness decreases with increasing age due to the senescence of immune function and a reduced immune response to antigens. There is also considerable vaccine effectiveness heterogeneity depending on the influenza activity time period, especially in seasons where two different circulating strains predominated, such as the 2018–19 season. This research aimed to assess the effect of age and high influenza activity period (HIAP) on the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) vs. trivalent high-dose influenza vaccine (HD-TIV) among elderly (≥65y) recipients in the U.S. Methods During the 2018–19 influenza season, a retrospective cohort analysis was conducted using professional fee, prescription claims and hospital charge master data in the U.S. The first sub-analysis evaluated rVE for different age groups (65–74 years, 75–84 years, ≥85 years). The second sub-analysis evaluated rVE overall, restricting the observation period from to HAIP: Dec 2018-Mar 2019 (August 2018-July 2019 in the main analysis). Adjusted analyses were conducted through inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted pairwise rVE for influenza-related hospitalizations/emergency room (ER) visits and office visits. Results Following IPTW, 561,315 recipients of aTIV and 1,672,779 of TIV-HD were identified. Following IPTW adjustment and Poisson regression, aTIV was more effective in reducing influenza-related office visits compared to TIV-HD (7.0%; 95% CI: 2.6%-11.2%) in the HIAP sub-analysis. In the age sub-analysis, the rVE favoring aTIV ranged from 5.1% (95% CI: -0.17%-10.1%) for the youngest group (65–74) up to 11.4% (95% CI: 0.6%-21.1%) for the eldest group (≥85y) for influenza-related office visits. No statistically significant differences were found for aTIV compared to TIV-HD for prevention of influenza-related hospitalizations/ER visits in the sub-analyses evaluated. Conclusion In adjusted analyses, aTIV reduced influenza-related office visits compared to TIV-HD within the two older age groups and HIAP sub-analysis. aTIV and TIV-HD demonstrated comparable reductions in influenza-related hospitalizations/ER visits. Disclosures Maarten Postma, Dr., IQVIA (Consultant) Stephen I. Pelton, MD, Merck vaccine (Consultant, Grant/Research Support)Pfizer (Consultant, Grant/Research Support)Sanofi Pasteur (Consultant, Other Financial or Material Support, DSMB)Seqirus Vaccine Ltd. (Consultant) Victoria Divino, PhD, Seiqrus Vaccines Ltd. (Consultant) Joaquin F. Mould-Quevedo, PhD, Seqirus Vaccines Ltd. (Employee, Shareholder) Drishti Shah, PhD, Seqirus Vaccines Ltd. (Consultant) Mitchell DeKoven, PhD, Seqirus Vaccines Ltd. (Consultant)


Author(s):  
Joshua D Doyle ◽  
Lauren Beacham ◽  
Emily T Martin ◽  
H Keipp Talbot ◽  
Arnold Monto ◽  
...  

Abstract Background Seasonal influenza causes substantial morbidity and mortality in older adults. High-dose inactivated influenza vaccine (HD-IIV), with increased antigen content compared to standard-dose influenza vaccines (SD-IIV), is licensed for use in people aged ≥65 years. We sought to evaluate the effectiveness of HD-IIV and SD-IIV for prevention of influenza-associated hospitalizations. Methods Hospitalized patients with acute respiratory illness were enrolled in an observational vaccine effectiveness study at 8 hospitals in the United States Hospitalized Adult Influenza Vaccine Effectiveness Network during the 2015–2016 and 2016–2017 influenza seasons. Enrolled patients were tested for influenza, and receipt of influenza vaccine by type was recorded. Effectiveness of SD-IIV and HD-IIV was estimated using a test-negative design (comparing odds of influenza among vaccinated and unvaccinated patients). Relative effectiveness of SD-IIV and HD-IIV was estimated using logistic regression. Results Among 1487 enrolled patients aged ≥65 years, 1107 (74%) were vaccinated; 622 (56%) received HD-IIV, and 485 (44%) received SD-IIV. Overall, 277 (19%) tested positive for influenza, including 98 (16%) who received HD-IIV, 87 (18%) who received SD-IIV, and 92 (24%) who were unvaccinated. After adjusting for confounding variables, effectiveness of SD-IIV was 6% (95% confidence interval [CI] −42%, 38%) and that of HD-IIV was 32% (95% CI −3%, 54%), for a relative effectiveness of HD-IIV versus SD-IIV of 27% (95% CI −1%, 48%). Conclusions During 2 US influenza seasons, vaccine effectiveness was low to moderate for prevention of influenza hospitalization among adults aged ≥65 years. High-dose vaccine offered greater effectiveness. None of these findings were statistically significant.


Sign in / Sign up

Export Citation Format

Share Document