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

This news release is intended for Health Professional media only.

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Seqirus, a global leader in influenza prevention, today presented new real-world evidence (RWE) at the European Scientific Working Group on Influenza (ESWI) virtual congress 2020 showing the clinical benefits of a cell-based, quadrivalent seasonal influenza vaccine (QIVc) in preventing influenza-related medical encounters compared to 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 aged ≥4 years (n=2,113,216) with at least one health condition, compared to QIVe in the 2018/19 U.S. influenza season.1
  • A separate 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 influenza-related and respiratory-related hospitalizations/ER visits 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 for individuals aged ≥4 years who received QIVc (n=2,125,430), significantly less influenza-rated medical encounters were experienced, compared with 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. 

Seasonal influenza can infect and across Europe, according to the World Health Organisation (WHO), each year up to 72,000 in Europe die of respiratory diseases linked to seasonal influenza.[4]

“The presentations at ESWI complement previous evidence demonstrating the clinical value of our differentiated, cell-based influenza vaccine,” said Raja Rajaram, MD, Regional Head of Medical Affairs- Europe and ME at Seqirus “This further supports our commitment to advancing our cell-based manufacturing technology.”

Cell-based influenza vaccine technology is an alternative to egg-based influenza vaccine manufacturing and may offer additional 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.[5] Seqirus currently operates a cell-based manufacturing facility in Holly Springs, NC, purpose-built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA).[6] Seqirus recently announced plans to build a new cell-based manufacturing facility in Australia.[7]

About the Studies

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 These results are consistent with the larger retrospective cohort study evaluating over 10 million vaccinated individuals ≥4 years where, QIVc was statistically significantly more effective than egg-derived QIVe.3

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 rVE of QIVc to QIVe in the reduction of influenza-related and respiratory-related hospitalizations/emergency room (ER) visits, as assessed by estimated relative vaccine effectiveness (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 (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, with rVEs for QIVc compared with QIVe against all-cause hospitalisation, of 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. However, rVEs against influenza-related hospitalizations/ER visits were not significantly different among vaccine groups in the sub-analyses.2

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

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 2018-2019 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 2018–2019 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.[8] Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death. 8 The UK National Health Service (NHS) recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.[9]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.8 Seasonal influenza can infect and across Europe, according to the World Health Organisation (WHO), each year up to 72,000 in Europe die of respiratory diseases linked to seasonal influenza.4

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.

 

UK/FLU/1220/0181

 

 

MEDIA CONTACT

Emmanuella Dekonor
+44 (0) 7920 500 496

Emmanuella.Dekonor@seqirus.com



[1] Constantina Boikos et al. 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] Stephen Pelton et al. 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] Constantina Boikos et al. 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] European World Health Organisation (EURO WHO). Influenza – estimating burden of disease; available at https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/seasonal-influenza/burden-of-influenza Accessed: 7 December 2020

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

[6] 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.

[7] Data on file. (2020). Seqirus USA Inc.

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

[9] National Health Service (NHS). Flu vaccine; available at https://www.nhs.uk/conditions/vaccinations/flu-vaccine-questions-answers/ Accessed on 7 December 2020