Seqirus Announces Late-Breaking Data at IDWeek 2020: New Real-World Evidence Shows Value of Adjuvanted Influenza Vaccine for Adults 65 Years and Older with Underlying Health Conditions
"The data presented at IDWeek 2020 add to a consistent and growing body of evidence for the MF59®-adjuvanted seasonal influenza vaccine as an enhanced influenza vaccine for adults 65 years and older," said
Influenza causes significant morbidity and mortality in adults 65 years and older, as demonstrated by higher hospitalization and death rates in recent years, compared with young, healthy adults.2 This population is subject to age-related immune decline, which can result in reduced immune response and in turn, reduced seasonal vaccine effectiveness.3,4 The MF59® adjuvant included in aTIV is designed to enhance the immune response to the influenza strains contained in the vaccine in adults 65 years and older.5,6,7
"At Seqirus we engage in scientific exchange with top infectious disease and influenza experts like those at IDWeek to build the body of seasonal influenza RWE, given the variable nature of the virus. This retrospective analysis underscores the importance of RWE to better understand how our influenza vaccines work in real-world settings," said
The retrospective study was conducted using more than 3.8 million electronic medical records across both seasons linked to pharmacy and medical claims of
This MF59®-adjuvanted seasonal influenza vaccine has an extensive clinical history, with 155+ million doses distributed over 20+ years* and licensure in 30 countries.8 The quadrivalent formulation of the MF59®-adjuvanted influenza vaccine, which contains an additional B strain to the trivalent formulation, was approved by the
*Doses distributed globally as of
About the Study
The objective of the study was to determine the relative vaccine effectiveness (rVE) of the MF59®-adjuvanted trivalent inactivated influenza vaccine (aTIV) compared to egg-derived standard quadrivalent inactivated influenza vaccines (IIV4) and high-dose trivalent inactivated influenza vaccine (TIV-HD) in preventing influenza-related medical encounters in older adults (≥65 years) with at least one comorbid health condition during the 2018-2018 and 2018-2019 influenza season.1
The retrospective study was conducted using more than 3.8 million electronic medical records linked to pharmacy and medical claims of
The primary outcome was influenza-related medical encounters in both the primary care and hospital settings.1 Adjusted odds ratios for age, sex, race, ethnicity, geographic region, comorbidities and weeks of vaccination were calculated for each health condition using inverse probability of treatment weighting.1 The rVE was determined using the formula (1-OR)*100 and reported with 95% confidence intervals (CI).1
Adjusted rVE indicated that older adults with underlying health conditions who received aTIV had statistically significant reductions in medical encounters compared to IIV4 for the 2017-2018 and 2018-2019 seasons.1 In the 2017-2018 season the adjusted rVE for adults with at least one health condition who received aTIV vs IIV4 was 7.1 (95% CI: 3.3, 10.8) for the 2017-2018 season and 20.4 (95% CI: 16.2, 24.4) for the 2018-2019 season.1 Non-statistically significant estimates precluded definitive conclusions for comparisons versus TIV-HD in reducing medical encounters for both seasons.1 For the 2017-2018 season, the adjusted VE of aTIV vs TIV-HD was -0.8 (95% CI: -8.9, 6.6) and 2.7 (95% CI: -2.7, 7.8) for the 2018-2019 season.1 Overall, the results of this study indicate the use of aTIV is more effective in reducing influenza-related medical encounters than standard quadrivalent seasonal influenza vaccines for adults ≥65 years with at least one healthcare condition.1
These results complement and are supportive of the primary analysis presented recently at the Annual Conference on Vaccinology Research (ACVR), hosted by the
A main limitation of this analysis is that the effectiveness outcome was not laboratory-confirmed influenza. However, results from a separate evaluation conducted within a larger population indicate alignment between influenza-related medical encounters and lab-confirmed influenza from
About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.11 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.11 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®, FLUAD® QUADRIVALENT, and MF59® are registered trademarks of
+1 (908) 608-7170
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 Data on file.
9 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC:
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