Seqirus Presents New Real-World Evidence on Relative Effectiveness of Adjuvanted Seasonal Influenza Vaccine in Adults 65 Years and Older at IDWeek 2020
aTIV was found to be more effective than a high-dose trivalent influenza vaccine (TIV-HD) in seven out of eleven outcomes assessed, including reducing influenza-related medical office visits and cardio-respiratory disease (CRD)-related hospitalizations/emergency room (ER) visits in adults 65 years and older during the 2018/19
The vaccines examined in this study are the only influenza vaccines specifically indicated for adults 65 years and older in the
"This study underscores the important role an adjuvanted influenza vaccine can play in improving influenza-related outcomes in older adults. These data are consistent with a recent publication in Vaccines that showed aTIV was more effective than a standard-dose, non-adjuvanted trivalent seasonal vaccine in reducing influenza-related office visits and hospitalizations during the 2017/18
This retrospective cohort analysis was conducted using data from several databases: professional fee claims, prescription claims and hospital charge master data in the
"Particularly for adults 65 years and older, the importance of influenza vaccination is evident now more than ever amidst the ongoing COVID-19 pandemic, as it can help to not only reduce the impact of influenza, but also minimize the additional burden on healthcare resources," said
This MF59® adjuvanted influenza vaccine has an extensive clinical legacy, with 155+ million doses distributed over 20+ years* and licensure in 30 countries.10 The quadrivalent formulation of the MF59® adjuvanted influenza vaccine, which adds an additional B strain to the trivalent formulation, was approved by the
*Doses distributed globally as of
About the Study
The primary objective of the study was to evaluate the relative vaccine effectiveness (rVE) against influenza-related hospitalizations/ER visits, influenza-related office visits and cardio-respiratory disease (CRD)-related hospitalizations/ER visits and compare all-cause and influenza-related costs associated with two vaccines specifically designed for older adults (≥ 65 years), adjuvanted trivalent influenza vaccine (aTIV) and high-dose trivalent influenza vaccine (TIV-HD) for the 2018/19 influenza season.1
A retrospective analysis was conducted using
Influenza-related hospitalizations/ER visits were defined as a hospitalization or ER visit with a diagnosis code for influenza.1 Influenza-related office visits were defined as a physician office visit in diagnosis (Dx) or outpatient charge description master (CDM) with a diagnosis code for influenza in any position.1 CRD-related outcomes were defined as a hospitalization or ER visit with a diagnosis code in any position for the cardio-respiratory event of interest.1
Additionally, an economic evaluation was conducted to compare influenza-related healthcare resource utilization (HCRU) and annualized costs between patients that received aTIV and TIV-HD.1 The analysis found that predicted mean annualized all-cause and influenza-related total costs were statistically comparable between aTIV and TIV-HD (
These findings are consistent with a previous Seqirus-sponsored study conducted during the 2017-18 influenza season using similar methodologies, recently published in Vaccines.8
This study was subject to the typical limitations associated with retrospective analysis studies.1 Though the cohorts were matched using standard techniques, there could be other variables not included in the study that could have skewed the balance of the groups.1 Additionally, there are limitations related to the utilization of claims data; for example, socioeconomic characteristics such as race/ethnicity, income, and access to care were not available.1 Finally, the claims database did not provide the clinical data to confirm influenza through lab or test results.1
About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.12 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.12 The
Seqirus is part of
CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life-saving products to more than 70 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about
This press release is issued from Seqirus U.S. Inc. in Summit New Jersey,
This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
FLUAD® (Influenza Vaccine, Adjuvanted) and FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)
INDICATION and IMPORTANT SAFETY INFORMATION
What is FLUAD® (Influenza Vaccine, Adjuvanted)
and FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)?
FLUAD and FLUAD QUADRIVALENT are vaccines that help protect people aged 65 years and older from the flu. Vaccination with FLUAD or FLUAD QUADRIVALENT may not protect all people who receive the vaccine.
Who should not get FLUAD
or FLUAD QUADRIVALENT?
You should not get FLUAD or FLUAD QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine.
Before receiving FLUAD or FLUAD QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:
- have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give FLUAD or FLUAD QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
- have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine
- have ever fainted when receiving a vaccine
What are the most common side effects of FLUAD and FLUAD QUADRIVALENT?
- Pain or tenderness where the vaccine was given
- Muscle aches
These are not all of the possible side effects of FLUAD or FLUAD QUADRIVALENT. You can ask your healthcare provider for more information.
What do I do if I have side effects?
Ask your healthcare provider for advice about any side effects that concern you.
To report SUSPECTED ADVERSE REACTIONS, contact
You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800–FDA–1088.
Before receiving this vaccine, please see the full US Prescribing Information for FLUAD or FLUAD QUADRIVALENT.
The information provided here does not include all that is known about FLUAD or FLUAD QUADRIVALENT. To learn more, talk about FLUAD with your healthcare provider.
FLUAD® and FLUAD® QUADRIVALENT are registered trademarks of
MF59® is a registered trademark of
+1 (908) 608-7170
1 Pelton, S.I., Divino, V., Postma, M.J., et al. (2020). MF59 ASSURANCE 2: A Real-world Study to Estimate the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-based
3 Monto AS, Ansaldi F, Aspinall R, et al. (2009). Influenza control in the 21st century: Optimizing protection of older adults. Vaccine. 2009;27(37):5043-5053.
4 McElhaney JE, Verschoor CP, Andrew MK, et al. (2020). The immune response to influenza in older humans: beyond immune senescence. BMC.
5 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034.
6 O'Hagan DT, Ott GS, Nest GV, et al. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-30.
7 Banzhoff A, Pellegrini M, Del Giudice G, et al. (2008). MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-24.
8 Pelton, S.I., Divino, V., Postma, M.J., et al. (2020). A real-world study evaluating the relative vaccine effectiveness of adjuvanted trivalent influenza vaccine compared to high-dose trivalent and other egg-based influenza vaccines among older adults in the US during the 2017-18 influenza season. Vaccines.
10 Data on file.
11 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC:
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