Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced new real-world evidence (RWE) supporting the effectiveness of its cell-based and adjuvanted seasonal influenza vaccines. These analyses from a comprehensive set of real-world studies will be presented at the global International Society for Influenza and other Respiratory Virus Diseases (ISIRV)-World Health Organization (WHO) Virtual Conference from October 19-21, 2021.
New data highlight the effectiveness of cell-based quadrivalent seasonal influenza vaccine (QIVc) compared to that of egg-based quadrivalent influenza vaccine (QIVe) against influenza-related medical encounters (IRMEs) during the 2019/20 U.S. influenza season in children (aged ≥4 to ≤17) and adults (aged ≥18).1,2 Results suggest that QIVc was more effective than QIVe at preventing IRMEs in both populations, with fewer documented IRMEs in children and adults.1,2
Additionally, data from two retrospective cohort analyses supporting effectiveness of adjuvanted trivalent seasonal influenza vaccine (aTIV) were presented.3,4 One analysis found fewer documented IRMEs in older populations (aged ≥65) vaccinated with aTIV compared with QIVe or non-adjuvanted high-dose trivalent influenza vaccine (TIV-HD).3 Another analysis found aTIV to be comparable to TIV-HD in the prevention of hospitalizations and emergency room (ER) visits related to influenza in older populations (aged ≥65).4
“The influenza virus is changing constantly, and as a result, vaccine reformulation with strain changes is done every year to help keep up with the variation, which is why it is important we use real-world datasets to evaluate vaccine effectiveness annually to supplement randomized clinical trials,” said study co-author Joaquin Mould-Quevedo, PhD, Head of Global Health Economics, Seqirus. “These retrospective studies, which include over 10 million vaccinated U.S. individuals, build on existing RWE in evaluating the effectiveness of influenza vaccines in real-world settings.”1,2,3,4
RWE allows for an assessment of influenza vaccine effectiveness on a yearly basis and provides an ever-growing dataset to evaluate real-world outcomes that reflect large, diverse populations of patients and healthcare settings.5 The U.S. Centers for Disease Control and Prevention (CDC) estimates that influenza resulted in approximately 140,000 to 810,000 hospitalizations on an annual basis since 2010.6 The CDC recommends seasonal influenza vaccination every year as the best way to prevent influenza for everyone six months of age and above who do not have contraindications.7 Influenza vaccination, according to the CDC, prevented an estimated 7.52 million illnesses, 3.69 million medical visits, 105,000 hospitalizations, and 6,300 deaths as a result of influenza during the 2019/20 season.8
“Across the Northern Hemisphere, we are now entering another flu season amidst an ongoing COVID-19 pandemic and overburdened healthcare systems,” said Gregg Sylvester, MD, Chief Medical Officer, Seqirus. “These data support that our vaccines can help reduce IRMEs and minimize the burden of influenza, among children and older populations.”
Relative Effectiveness of QIVc in U.S. Population (4-64yrs)
Findings from a retrospective cohort study suggest that cell-based quadrivalent influenza vaccine (QIVc) was more effective in preventing inpatient and outpatient influenza-related medical encounters (IRMEs) compared to egg-based quadrivalent influenza vaccine (QIVe) in adults (aged ≥18 years of age) during the 2019/20 U.S. influenza season.1 Adult subjects who received QIVc (1,499,215) or QIVe (4,126,263) were identified using electronic medical records linked to pharmacy and medical claims data where available.1 Adjusted results show that QIVc was associated with higher relative vaccine effectiveness (rVE) compared to QIVe in preventing IRMEs, with fewer documented IRMEs in adults vaccinated with QIVc vs QIVe (9.5% CI 7.9, 11.1).1
A separate retrospective cohort study was presented with a patient pool of children aged ≥4 to ≤17 years old, comparing the effectiveness of QIVc (60,480) in preventing inpatient and outpatient IRMEs compared to QIVe (1,240,990) during the 2019/20 U.S. influenza season.2 Subjects were identified using electronic medical records linked to pharmacy and medical claims where available.2 Adjusted results show that QIVc was associated with higher rVE compared to QIVe in preventing IRMEs, with fewer documented IRMEs in children vaccinated with QIVc vs QIVe (12.2% [95% CI 7.5,16.6]).2
QIVc utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing.9 Cell-based influenza vaccines are designed to produce an exact match to WHO-selected influenza virus strains.9
Relative Effectiveness of aTIV Among Older U.S. Adults 65 Years Old
Findings from a retrospective cohort analysis evaluating rVE of adjuvanted trivalent influenza vaccine (aTIV) compared to non-adjuvanted high-dose trivalent influenza vaccine (TIV-HD) in older adults (aged ≥65) found aTIV (798,987) was statistically comparable to TIV-HD (1,655,979) in the prevention of influenza-related hospitalizations/ER visits during the 2019/20 U.S. influenza season in high influenza activity period (HIAP) (3.6%; 95% CI -2.4%,9.3%).4 Results were consistent across both sub-analyses, including by age group and during HIAP (Dec 8, 2019-Mar 7, 2020). An adjuvant can help boost a weakened immune system in those 65 and older.10
A separate retrospective cohort study was presented that evaluated rVE of aTIV compared to QIVe and TIV-HD in older adults (aged ≥65) in preventing IRMEs in either outpatient or inpatient settings during the 2019/20 influenza season. This study included 936,508 patients who received aTIV, 651,034 who received QIVe, and 1,813,819 who received TIV-HD.3 This study found fewer IRMEs occurred in older adults who received aTIV compared with QIVe or TIV-HD which was driven by a higher prevention of outpatient IRMEs (27.5% [95% CI 24.4%,30.5%] vs QIVe and 13.9% [95% CI 10.7%,17.0%] vs TIV-HD).3
These studies were subject to the typical limitations associated with retrospective cohort analyses. Observational studies have limitations including the potential for selection bias and residual confounding. Individual study limitations may include: retrospective analyses, a potential lack of laboratory confirmed influenza, and varying data sources.
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 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.11 Estimates from the CDC report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.12 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.13 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.13 The CDC recommends that people get vaccinated by the end of October.13
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
About CSL
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 100 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 CSL Limited, visit www.csl.com.
For more information visit www.seqirus.com and www.csl.com.
Intended Audience
This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.
Forward-Looking Statements
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.
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FLUCELVAX® QUADRIVALENT (Influenza Vaccine) IMPORTANT SAFETY INFORMATION
What is FLUCELVAX® QUADRIVALENT (Influenza Vaccine)?
FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with FLUCELVAX QUADRIVALENT may not protect all people who receive the vaccine.
Who should not get FLUCELVAX QUADRIVALENT?
You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine.
Before receiving FLUCELVAX 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 FLUCELVAX 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 FLUCELVAX QUADRIVALENT?
- pain, redness, swelling, or a raised hardened area where the vaccine was given
- headache
- overtiredness with low energy
- muscle aches
- feeling unwell (malaise)
Additional side effects seen in children include:
- tenderness or bruising where vaccine was given
- sleepiness
- irritability
- diarrhea
- changes in eating habits
These are not all of the possible side effects of FLUCELVAX QUADRIVALENT. You can ask your healthcare provider for more information and for advice about any side effects that concern you.
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1 855 358-8966 or VAERS at 1‐800‐822‐7967 or www.vaers.hhs.gov.
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 FLUCELVAX QUADRIVALENT. The information provided here does not include all that is known about FLUCELVAX QUADRIVALENT. To learn more, talk with your healthcare provider or pharmacist.
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FLUAD® (Influenza Vaccine, Adjuvanted)
INDICATION and IMPORTANT SAFETY INFORMATION
What is FLUAD® (Influenza Vaccine, Adjuvanted)?
FLUAD is a vaccine that helps protect people aged 65 years and older from the flu. Vaccination with FLUAD may not protect all people who receive the vaccine.
Who should not get FLUAD?
You should not get FLUAD 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 reaction to a previous influenza vaccine.
Before receiving FLUAD, 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 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?
- Pain or tenderness where the vaccine was given
- Muscle aches
- Headache
- Fatigue
These are not all of the possible side effects of FLUAD. 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 Seqirus USA Inc. at 1‐844‐275‐ 2461 or VAERS at 1‐800‐822‐7967 or www.vaers.hhs.gov.
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.
The information provided here does not include all that is known about FLUAD. To learn more, talk about FLUAD with your healthcare provider.
FLUAD® and FLUCELVAX® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.
USA-IV-21-0007
MEDIA CONTACT
Jon Steed
+1 (908) 517-6379
Jon.Steed@Seqirus.com
REFERENCES
1 Boikos, C., Bonafede, M., Fisher, L., et. al. (2021). Relative Effectiveness of Cell–Derived Quadrivalent Influenza Vaccine (IIV4c) Versus Egg-Derived Quadrivalent Influenza Vaccine (IIV4e) in Preventing Influenza-Related Medical Encounters in Adults During the 2019-2020 Influenza Season in the United States. Presented at ISIRV-WHO 2021.
2 Boikos, C., Bonafede, M., Fisher, L., et. al. (2021). Relative Effectiveness of Cell–Derived Quadrivalent Influenza Vaccine (IIV4c) Versus Egg-Derived Quadrivalent Influenza Vaccine (IIV4e) in Preventing Influenza-Related Medical Encounters in a Pediatric Population During the 2019-2020 Influenza Season in the United States. Presented at ISIRV-WHO 2021.
3 Boikos, C., Bonafede, M., Fisher, L., et. al. (2021). Relative effectiveness of MF-59-adjuvanted, trivalent influenza vaccine vs quadrivalent influenza vaccine and high-dose trivalent influenza vaccine in preventing influenza-related medical encounters in adults ≥65 years of age during the 2019-2020 influenza season in the United States Presented at ISIRV-WHO 2021.
4 DeKoven, M., Divino, V., Levin, M., et. al. (2021). A Real-World Comparison between Adjuvanted Trivalent Influenza Vaccine and Trivalent High-Dose Influenza Vaccine by Age and Period of High Influenza Activity for the 2019-20 Season among U.S. Elderly. Presented at ISIRV-WHO 2021.
5 Katkade VB, Sanders KN, Zou KH. Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making. J Multidiscip Healthc.2018;11:295-304.
6 CDC. (2021). Disease Burden of Influenza. Retrieved from: https://www.cdc.gov/flu/about/burden/index.html. Accessed October 2021.
7 CDC. (2021). WG Considerations and Proposed Influenza Vaccine Recommendations, 2021-22 . Retrieved from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-influenza-grohskopf-508.pdf. Accessed October 2021.
8 CDC. (2020). Estimated Influenza Illnesses, Medical visits, and Hospitalizations Averted by Vaccination in the United States — 2019–2020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden-averted/2019-2020.htm. Accessed October 2021.
9 CDC. (2020). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.htm. Accessed October 2021.
10 CDC. (2021). Adjuvanted Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/adjuvant.htm. Accessed September 2021.
11 CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed October 2021.
12 CDC. (2020). Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States — 2019–2020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2019-2020.html. Accessed October 2021.
13 Centers for Disease Control and Prevention (CDC). (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed October 2021.