Seqirus Presents New Real-World Evidence Demonstrating Effectiveness of Cell-Based and Adjuvanted Seasonal Influenza Vaccines at IDWeek 2021

SUMMIT, N.J., Sept. 29, 2021 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX: CSL), today announced data supporting the effectiveness of both cell-based and adjuvanted seasonal influenza vaccines from two real-world studies conducted during the 2019/2020 influenza season in the U.S. These analyses will be presented today at the virtual IDWeek 2021 conference.

The data highlight the effectiveness of cell-based quadrivalent influenza vaccine (QIVc) compared to that of standard-dose egg-based quadrivalent influenza vaccine (QIVe-SD) in preventing hospitalizations and emergency room (ER) visits during the 2019/20 influenza season in the general population (aged 4-64) as well as a sub analysis of individuals at higher risk for influenza complications.^1,2 A separate analysis showed that adjuvanted standard dose trivalent vaccine (aTIV) is as effective as a non-adjuvanted high-dose trivalent vaccine (TIV-HD) for the prevention of hospitalizations and ER visits related to influenza and hospitalizations/ER visits for cardio-respiratory disease (CRD).³

"In our analyses, QIVc and aTIV demonstrated effectiveness in preventing hospitalizations related to influenza, during both the broader influenza season and the high activity period," said study co-author Joaquin Mould-Quevedo, PhD, Head of Global Health Economics, Seqirus. "These data further underscore the public health benefits of innovative technologies, including cell-based and adjuvanted technologies, in producing seasonal influenza vaccines."

Since the influenza virus is incredibly variant and can change often, real world evidence (RWE) has become increasingly important in providing an inclusive look at vaccine safety and effectiveness.⁴ RWE allows for an assessment of influenza vaccine effectiveness on a yearly basis and provides an ever-growing data set to evaluate real-world outcomes that reflect large, diverse populations of patients and healthcare settings.⁴

"As we potentially face another unprecedented flu season, these studies reinforce the important role our vaccines play in reducing hospitalizations, which in turn helps mitigate additional pressure on already-stretched health systems," said Gregg Sylvester, MD, Chief Medical Officer, Seqirus. "We continue making critical R&D investments to measure how our influenza vaccines perform in real-world settings and to advance next-generation technology platforms that help safeguard people and communities from influenza."

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 2010.⁵ 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.⁶

Relative Effectiveness of QIVc in U.S. Population (4-64yrs)

In an oral presentation, Seqirus presented findings from a retrospective cohort analysis comparing the effectiveness of cell-based quadrivalent influenza vaccine (QIVc) in preventing influenza-related and respiratory-related hospitalizations and emergency room (ER) visits compared to standard-dose egg-based quadrivalent influenza vaccine (QIVe-SD) during the 2019/20 season.¹ For the study, 1,150,134 patients aged 4-64 who received QIVc and 3,924,819 who received QIVe-SD were identified using administrative claims data. Adjusted results show that QIVc was associated with  higher relative vaccine effectiveness (rVE) compared to QIVe-SD against influenza-related hospitalizations/ER visits (5.3 percent) and any respiratory hospitalizations/ER visits (8.2 percent).¹ In an assessment of the high influenza activity period (HIAP), results show that QIVc was associated with a higher rVE compared to QIVe-SD for influenza-related hospitalizations/ER visits (5.7 percent) and any respiratory hospitalizations/ER visits (7.3 percent).¹

Seqirus also presented a poster featuring additional findings of a sub-analysis of individuals at higher risk of flu complications, showing improved vaccine effectiveness against influenza-related and respiratory-related hospitalizations/ER visits during the 2019/20 season with QIVc compared with QIVe-SD.²

Findings from this retrospective cohort analysis add to a growing body of evidence supporting the safety and utility of cell-based influenza vaccines like QIVc.⁷ QIVc utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing.⁸ Cell-based influenza vaccines are designed to produce an exact match to WHO-selected influenza virus strains.⁸

Relative Effectiveness of Adjuvanted Trivalent Influenza Vaccine (aTIV) among Older U.S. Adults

A separate poster presentation highlighted findings from a retrospective cohort analysis evaluating rVE of adjuvanted trivalent influenza vaccine (aTIV) compared to non-adjuvanted high-dose trivalent influenza vaccines (HD) in older adults during the 2019/20 influenza season.³ An adjuvant can help boost a weakened immune system in those 65 and older.⁹ This study found aTIV was statistically comparable to TIV-HD in the prevention of influenza- related hospitalizations/ER visits and all-cause hospitalizations. 3 Comparable outcomes were also found in reduction of any hospitalization/ER visits for CRD.³   

Both 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.¹⁰ Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.¹⁰  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.¹⁰  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.¹¹ The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.6 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.¹² The CDC recommends that people get vaccinated by the end of October. 12 For non-pregnant adults, getting vaccinated too early (for example, in July or August), should be avoided, unless there is concern that later vaccination may not be possible, as it can be associated with reduced protection against influenza infection later in the flu season.¹² However, getting vaccinated later can still be beneficial and vaccination should continue to be offered throughout the influenza season, even into January or later.¹²

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.

FLUCELVAX® QUADRIVALENT (Influenza Vaccine) IMPORTANT SAFETY INFORMATION

What is FLUCELVAX® QUADRIVALENT (Influenza Vaccine)?

FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 2 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, or a raised hardened area or swelling where the vaccine was given
• headache
• tiredness
• muscle aches
• feeling unwell (malaise)

Additional side effects seen in children include:

• tenderness or bruising where vaccine was given
• sleepiness
• irritability
• 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.

FLUCELVAX® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

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.

USA-QIVc-21-0097

MEDIA CONTACT
Maria Tortoreto
+1 (201) 248-5208
[email protected]

REFERENCES

¹DeKoven, M., Divino, V., Mould-Quevedo, J., et. al. (2021). Relative Vaccine Effectiveness Against Influenza-Related and Any Respiratory-Related Hospital Encounter During the 2019/20 High Influenza Activity Period: A Comprehensive Real-World Analysis to Compare Quadrivalent Cell-based and Egg-based Influenza Vaccines. Presented IDWeek 2021.

²DeKoven, M., Divino, V., Mould-Quevedo, J., et. al. (2021). Relative vaccine effectiveness against influenza-related hospitalizations and respiratory events during the 2019/20 influenza season in U.S. children and adults. A Real-World Evidence comparison between quadrivalent cell-based and egg-based influenza vaccines. Presented IDWeek 2021.

³DeKoven, M., Divino, V., Drishti, S., et. al. (2021). 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. Presented IDWeek 2021.

⁴Katkade 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.

⁵CDC. (2021). Disease Burden of Influenza. Retrieved from: https://www.cdc.gov/flu/about/burden/index.html. Accessed September 2021.

⁶CDC. (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 September 2021.

⁷Bart S., Cannon K., Herrington D. et al. Immunogenicity and safety of a cell culture-based quadrivalent influenza vaccine in adults: A Phase III, double-blind, multicenter, randomized, non-inferiority study. Human Vaccines & Immunotherapies 2016;12 (9):2278-88.

⁸CDC. (2020). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/cell-based.htm. Accessed September 2021.

⁹CDC. (2021). Adjuvanted Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/prevent/adjuvant.htm. Accessed September 2021.

¹⁰CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm Accessed September 2021.

¹¹CDC. (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 September 2021.

¹²CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed September 2021.

SOURCE Seqirus

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