Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccines Among US Medicare Beneficiaries in Preventing Postinfluenza Deaths During 2012–2013 and 2013–2014

2017 ◽  
Vol 215 (4) ◽  
pp. 510-517 ◽  
Author(s):  
David K. Shay ◽  
Yoganand Chillarige ◽  
Jeffrey Kelman ◽  
Richard A. Forshee ◽  
Ivo M. Foppa ◽  
...  
Author(s):  
Hector S Izurieta ◽  
Michael Lu ◽  
Jeffrey Kelman ◽  
Yun Lu ◽  
Arnstein Lindaas ◽  
...  

Abstract Background Around 50,000 influenza-associated deaths occur annually in the U.S., overwhelmingly among individuals ages >65 years. Although vaccination is the primary prevention tool, investigations have shown low vaccine effectiveness (VE) in recent years, particularly among the elderly. We analyzed the relative VE (RVE) of all influenza vaccines among Medicare beneficiaries ages >65 years to prevent influenza hospital encounters during the 2019-20 season. Methods Retrospective cohort study using Poisson regression and inverse probability of treatment weighting (IPTW). Exposures included egg-based high-dose trivalent (HD-IIV3), egg-based adjuvanted trivalent (aIIV3), egg-based standard dose (SD) quadrivalent (IIV4), cell-based SD quadrivalent (cIIV4), and recombinant quadrivalent (RIV4) influenza vaccines. Results We studied 12.7 million vaccinated beneficiaries. Following IPTW, cohorts were well balanced for all covariates and health-seeking behavior indicators. In the adjusted analysis, RIV4 (RVE 13.3%, 95% CI 7.4%, 18.9%), aIIV3 (RVE 8.2%, 95% CI 4.2%, 12.0%), and HD-IIV3 (RVE 6.8%, 95% CI 3.3%, 10.1%) were significantly more effective in preventing hospital encounters than the reference egg-based SD IIV4, while cIIV4 was not significantly more effective than IIV4 (RVE 2.8%, 95% CI -2.8%, 8.2%). Our results were consistent across all analyses. Conclusions In this influenza B-Victoria and A(H1N1)-dominated season, RIV4 was moderately more effective than other vaccines, while the HD-IIV3 and aIIV3 were more effective than the IIV4 vaccines, highlighting the contributions of antigen amount and adjuvant use to VE. Egg adaptation likely did not substantially affect our RVE evaluation. Our findings, specific to the 2019-20 season, should be evaluated in other studies using virological case confirmation.


2019 ◽  
Vol 220 (9) ◽  
pp. 1511-1520 ◽  
Author(s):  
Yun Lu ◽  
Yoganand Chillarige ◽  
Hector S Izurieta ◽  
Yuqin Wei ◽  
Wenjie Xu ◽  
...  

AbstractBackgroundStudies have found that the high-dose influenza vaccine has a higher relative vaccine effectiveness (RVE) versus standard-dose vaccines in some seasons. We evaluated the effect of age on the RVE of high-dose versus standard-dose influenza vaccines among Medicare beneficiaries.MethodsA 6-season retrospective cohort study from 2012 to 2018 among Medicare beneficiaries aged ≥65 years was performed. Poisson regression was used to evaluate the effect of age on the RVE of high-dose versus standard-dose influenza vaccines in preventing influenza-related hospitalizations.ResultsThe study included >19 million vaccinated beneficiaries in a community pharmacy setting. The Poisson models indicated a slightly increasing trend in RVE with age in all seasons. The high-dose vaccine was more effective than standard-dose vaccines in preventing influenza-related hospital encounters (ie, influenza-related inpatient stays and emergency department visits) in the 2012–2013 (RVE, 23.1%; 95% confidence interval [CI], 17.6%–28.3%), 2013–2014 (RVE, 15.3%; 95% CI, 7.8%–22.3%), 2014–2015 (RVE, 8.9%; 95% CI, 5.6%–12.1%), and 2016–2017 (RVE, 12.6%; 95% CI, 6.3%–18.4%) seasons and was at least as effective in all other seasons. We also found that the high-dose vaccine was consistently more effective than standard-dose vaccines across all seasons for people aged ≥85 years. Similar trends were observed for influenza-related inpatient stays.ConclusionsThe RVE of high-dose versus standard-dose influenza vaccines increases with age.


2020 ◽  
Vol 222 (2) ◽  
pp. 278-287 ◽  
Author(s):  
Hector S Izurieta ◽  
Yoganand Chillarige ◽  
Jeffrey Kelman ◽  
Yuqin Wei ◽  
Yun Lu ◽  
...  

Abstract Background Studies among individuals ages ≥65 years have found a moderately higher relative vaccine effectiveness (RVE) for the high-dose (HD) influenza vaccine compared with standard-dose (SD) products for most seasons. Studies during the A(H3N2)-dominated 2017–2018 season showed slightly higher RVE for the cell-cultured vaccine compared with SD egg-based vaccines. We investigated the RVE of influenza vaccines among Medicare beneficiaries ages ≥65 years during the 2018–2019 season. Methods This is a retrospective cohort study using inverse probability of treatment weighting and Poisson regression to evaluate RVE in preventing influenza hospital encounters. Results Among 12 777 214 beneficiaries, the egg-based adjuvanted (RVE, 7.7%; 95% confidence interval [CI], 3.9%–11.4%) and HD (RVE, 4.9%; 95% CI, 1.7%–8.1%) vaccines were marginally more effective than the egg-based quadrivalent vaccines. The cell-cultured quadrivalent vaccine was not significantly more effective than the egg-based quadrivalent vaccine (RVE, 2.5%; 95% CI, −2.4% to 7.3%). Conclusions We did not find major effectiveness differences between licensed vaccines used among the elderly during the 2018–2019 season. Consistent with prior research, we found that the egg-based adjuvanted and HD vaccines were slightly more effective than the egg-based quadrivalent vaccines.


2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S456-S457
Author(s):  
Cynthia Lucero-Obusan ◽  
Patricia Schirmer ◽  
Aaron Wendelboe ◽  
Russell Ryono ◽  
Gina Oda ◽  
...  

2017 ◽  
Vol 218 (2) ◽  
pp. 336-337 ◽  
Author(s):  
Karl Madaras-Kelly ◽  
Richard Remington ◽  
Hayli Hruza ◽  
Dong Xu

Vaccine ◽  
2019 ◽  
Vol 37 (11) ◽  
pp. 1484-1490 ◽  
Author(s):  
Yinong Young-Xu ◽  
Julia Thornton Snider ◽  
Robertus van Aalst ◽  
Salaheddin M. Mahmud ◽  
Edward W. Thommes ◽  
...  

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S764-S764 ◽  
Author(s):  
Lee-Jah Chang ◽  
Ya Meng ◽  
Helene Janosczyk ◽  
Victoria Landolfi ◽  
H Keipp Talbot ◽  
...  

Abstract Background Older adults (≥65 years of age) remain at increased risk of influenza because they do not respond to standard dose influenza vaccines as well as younger adults. A high dose, inactivated trivalent influenza vaccine, IIV3-HD, containing four times the antigen content (60 µg hemagglutinin per influenza strain) of standard-dose influenza vaccines has been available in the United States since 2010. Two distinct B influenza lineages (Victoria and Yamagata) have co-circulated for over a decade, making it difficult to predict which will predominate the next season. IIV4-HD has been developed to address the frequent influenza B strain mismatches by incorporating a strain from each B lineage. This pivotal Phase III study evaluated the safety and immunogenicity of IIV4-HD as compared with two IIV3-HD vaccines. Method A randomized, modified double-blind, multicenter study (NCT03282240) was conducted in 2670 healthy subjects in the United States, who were randomly assigned to receive IIV4-HD, a licensed IIV3-HD, or an IIV3-HD with the alternate B influenza strain. Using the hemagglutinin inhibition (HAI) assay at baseline and 28 days after vaccination, post-vaccination geometric mean titers and seroconversion rates were measured. Safety data were collected through 6 months post-vaccination. Result IIV4-HD was noninferior to the licensed IIV3-HD and the investigational IIV3-HD (containing the alternate B strain) for all four influenza strains as assessed by HAI GMTs and seroconversion rates. Moreover, IIV4-HD induced a superior immune response (HAI GMTs and seroconversion rates) compared with the immune response induced by the IIV3-HD that does not contain the corresponding B strain. Reactogenicity profiles were comparable across all study groups. Most unsolicited adverse events were of Grade 1 or Grade 2 intensity. One serious adverse event considered related by the Investigator was reported in the IIV4-HD group. Conclusion Vaccination of adults 65 years of age and older with IIV4-HD was found to be noninferior to two IIV3-HD vaccines with a similar safety profile. The addition of a second B lineage strain does not adversely affect the safety or immunogenicity profile of IIV4-HD compared with IIV3-HD. Disclosures L. J. Chang, Sanofi Pasteur: Employee, Salary. Y. Meng, Sanofi Pasteur: Employee, Salary. H. Janosczyk, Sanofi Pasteur: Employee, Salary. V. Landolfi, Sanofi Pasteur: Employee, Salary. H. K. Talbot, Sanofi Pasteur: Investigator, Research grant. Gilead: Investigator, Research grant. MedImmune: Investigator, Research grant. Vaxinnate: Safety Board, none. Seqirus: Safety Board, none.


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