Seqirus Presents Real-World Data for Cell-Based Quadrivalent Seasonal Influenza Vaccine (QIVc) at ESWI 2020

SUMMIT, N.J., Dec. 9, 2020 /PRNewswire/ -- Seqirus, a global leader in influenza prevention, today presented new real-world evidence (RWE) at the European Scientific Working Group on Influenza (ESWI) 2020 showing the clinical benefits of a cell-based, quadrivalent seasonal influenza vaccine (QIVc) in preventing influenza-related medical encounters compared to an egg-based quadrivalent influenza vaccine (QIVe) during the 2018/19 United States (U.S.) influenza season.^1,2,3

The following data in support of QIVc were presented at the virtual conference:

• A late-breaking poster presentation demonstrating that QIVc prevented significantly more influenza-related medical encounters among individuals age ≥4 years (n=2,113,216) with at least one health condition, compared to QIVe in the 2018/19 U.S. influenza season.¹
• An oral presentation highlighting results from a retrospective cohort analysis which indicate that among subjects 4-64 years old, QIVc (n=669,030) was significantly more effective in reducing hospitalizations/ER visits caused by influenza and respiratory related illness compared with QIVe (n=3,062,797) in the 2018/19 U.S. influenza season.²
• A poster presentation further supporting the clinical benefit of QIVc, indicating that individuals age ≥4 years who received QIVc (n=2,125,430) experienced significantly less influenza-related medical encounters than individuals who received QIVe (n=8,000,903) in the 2018/19 U.S. influenza season.³

“The data presented at ESWI demonstrate the value of real-world evidence for seasonal influenza vaccines, particularly given the size of the datasets for these studies,” said Dr. Joan Puig-Barberà, Emeritus Senior Researcher from the Vaccines Research Area FISABIO in Valencia. “Influenza is an incredibly variable virus, so having real-world data in addition to randomized control trial data allows us to have a better understanding of the effectiveness of seasonal influenza vaccines under varying circumstances.”

The Centers for Disease Control and Prevention (CDC) recommends everyone six months and older without contraindications receive an annual influenza vaccine as the best way to prevent seasonal influenza.⁴ Annually in the U.S., the incidence of influenza is higher than most other vaccine-preventable disease and places a substantial burden on the population.^5,6 Influenza vaccination can reduce illness from influenza, doctors’ visits, missed work and school, as well as reduce flu-related hospitalizations and deaths.⁷

“These studies underscore the important role of a cell-based influenza vaccine in reducing medical encounters during the 2018/19 US influenza season, which further supports our commitment to advancing our cell-based manufacturing technology,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. “Particularly amidst the COVID-19 pandemic, we are grounded in our mission to have as many people as possible receive a flu vaccine to not only protect against influenza, but also to reduce the impact on our healthcare systems.”

Cell-based influenza vaccine technology is an alternative to egg-based influenza vaccine manufacturing and may offer advantages over the standard influenza manufacturing process including being more scalable and offering faster production, both critically important in the event of an influenza pandemic.⁸

Seqirus currently operates a state-of-the-art cell-based manufacturing facility in Holly Springs, NC, purpose-built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to increase cell-based vaccine manufacturing capacity and combat pandemic influenza threats.⁹ Seqirus recently announced plans to build a new, world-class cell-based manufacturing facility in Australia, which will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere.¹⁰

About the Studies

Collectively these studies showed the clinical benefits of QIVc compared to QIVe in preventing influenza-related medical encounters specifically during the 2018/19 U.S. influenza season.

Relative Effectiveness of Cell-Derived versus Egg-derived Quadrivalent Influenza Vaccines in Individuals with Underlying Medical Conditions in the U.S. 2018-2019 Influenza Season
This retrospective cohort analysis was conducted among individuals ≥4 years of age with ≥1 health condition, who received either QIVc or QIVe The study looked at the relative effectiveness (rVE) of these influenza vaccines in reducing influenza-related medical encounters for the 2018/19 influenza season in the United States.¹

The study sample comprised 2,113,216 individuals with ≥1 medical condition. The study analyzed patient-level electronic medical records linked to pharmacy and medical claims.¹ Diabetes and chronic pulmonary disease (including asthma) were the most common conditions in the study cohort.¹ Results indicate that, after adjustment, QIVc was significantly more effective in reducing influenza-related medical encounters compared to QIVe for individuals ≥4 years of age with ≥1 medical condition (13.4% [95% CI: 11.4%-15.4%]) and for those with chronic pulmonary disease (18.7% [95% CI: 16.0%-21.3%]) (including asthma) (21.4% [95% CI: 18.4%-24.3%])) and rheumatic disease (11.8% [95% CI: 3.6%-19.3%]).¹

CELL RESPONSE 2: Relative vaccine effectiveness against influenza-related hospitalizations and serious respiratory events during the 2018/19 influenza season in children and adults. Comparison between quadrivalent cell-based and egg-based influenza vaccines
This retrospective cohort analysis compared the relative vaccine effectiveness (rVE) of QIVc to QIVe in the reduction of influenza and respiratory-related hospitalizations/emergency room (ER) visits, as assessed by estimated rVE, among subjects 4-64 years old during the 2018/19 influenza season in the U.S.²

The study sample comprised 669,030 QIVc recipients and 3,062,797 QIVe recipients. The study analyzed administrative claims data in the U.S. (IQVIA PharMetrics® Plus).² Results indicate that, after adjustment for confounders, QIVc was significantly more effective in reducing influenza-related hospitalizations/ER visits (6.49% [95%CI: 0.08%-12.50%]) and respiratory-related hospitalizations/ER visits (7.74% [95%CI: 6.09%-9.37%]) among subjects 4-64 years old, compared with QIVe.² Similar trends were seen for the 4-17 years, 18-64 years and high-risk subgroups (defined based on clinical risk groups considered at higher risk for influenza complications); for instance, rVEs for QIVc compared to QIVe-SD against all-cause hospitalizations were 16.12% (95% CI: 8.35%-23.23%), 6.37% (95% CI: 5.11%-7.62%) and 3.97% (95% CI: 2.20%-5.71%), respectively.² However, rVEs against influenza-related hospitalizations/ER visits were not significantly different among vaccine groups in the sub-analyses due to limited sample size for subgroup comparisons.²

Relative Effectiveness of Cell–Derived Quadrivalent Inactivated Influenza Vaccine Versus Egg-Derived in Preventing Influenza-Related Medical Encounters During the 2018-2019 Influenza Season in the United States
This retrospective cohort analysis compared QIVc versus a QIVe in preventing influenza-related medical encounters, as assessed by estimated rVE, among individuals ≥4 years of age during the 2018/19 influenza season in the U.S.³

The retrospective study sample comprised 2,125,430 QIVc recipients and 8,000,903 QIVe recipients. The study analyzed an integrated dataset linking patient-level primary care electronic medical records (EMRs) with pharmacy and medical claims data.³ Influenza immunizations were ascertained using CVX (vaccine administered), CPT (Current Procedural Terminology) and NDC (National Drug Code) codes from subject EMRs and claims.³ The primary outcome was influenza-related medical encounters (primary care and hospital), defined using International Statistical Classification of Diseases and Related Health Problems (ICD)-10 codes.³ Results indicate that, after adjustment, there was a significantly greater reduction in influenza-related medical encounters with QIVc compared with QIVe (7.6%, [95%CI: 6.5%-8.6%]) in the overall cohort ≥4 years of age, for the 2018/19 influenza season in the U.S.³

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 CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.⁴ 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 Preliminary estimates from the CDC report that from October 1, 2019, through April 4, 2020, there were an estimated 410,000 to 740,000 influenza-related hospitalizations in the U.S.¹² 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.¹¹ The CDC recommends that people get vaccinated by the end of October.⁷ Getting vaccinated too early (for example, in July or August), can be associated with reduced protection against influenza infection later in the flu season.⁷ However, getting vaccinated later can still be beneficial and vaccination should continue to be offered throughout the influenza season, even into January or later.⁷

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 4 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:

• 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.

Ask your health care 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 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.

US/GLB/XQIV/1120/0013

MEDIA CONTACT
Polina Miklush
+1 (908) 608-7170
Polina.Miklush@Seqirus.com

REFERENCESS

¹ Relative Effectiveness of Cell-Derived versus Egg-derived Quadrivalent Influenza Vaccines in Individuals with Underlying Medical Conditions in the U.S. 2018-2019 Influenza Season. Presented at ESWI 2020.

² Relative vaccine effectiveness against influenza-related hospitalizations and serious respiratory events during the 2018/19 influenza season in children and adults. Comparison between quadrivalent cell-based and egg-based influenza vaccines. Presented at ESWI 2020.

³ Relative Effectiveness of Cell–Derived Quadrivalent Inactivated Influenza Vaccine (ccIIV4) Versus Egg-Derived IIV4 in Preventing Influenza-Related Medical Encounters During the 2018-2019 Influenza Season in the United States. Presented at ESWI 2020.

⁴ CDC. (2019). Key Facts about Seasonal Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed November 2020.

⁵ CDC. Disease burden of influenza. Retrieved from: https://www.cdc.gov/flu/about/burden/index.html. Accessed November 2020.

⁶ Bekkat-Berkani R, Romano-Mazzotti L. Understanding the unique characteristics of seasonal influenza illness to improve vaccine uptake in the US. Vaccine. 2018;36(48):7276-7285. doi:10.1016/j.vaccine.2018.10.027

⁷ CDC. (2020). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed November 2020.

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

⁹ This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I.

¹⁰ Data on file. (2020). Seqirus USA Inc.

¹¹ CDC. (2019). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed September 2020. Accessed November 2020.

¹² CDC. (2020). 2019-2020 U.S. Flu season: Preliminary burden estimates. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accessed September 2020. Accessed November 2020.

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