Seqirus to Present Data on Pandemic and Seasonal Influenza Vaccines at OPTIONS X Conference

Seqirus announced it will feature data in 3 presentations and 24 posters on the company’s adjuvant and cell-based vaccines for seasonal and pandemic influenza at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore.

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Summit, NJ – August 22, 2019

Seqirus, a global leader in influenza prevention, today announced it will feature data in 3 presentations and 24 posters on the company’s adjuvant and cell-based vaccines for seasonal and pandemic influenza at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore.

In particular, Seqirus will present clinical data on a seasonal adjuvanted influenza vaccine, including studies that assessed immune response against homologous and heterologous influenza strains and cross-reactive antibodies in young children (≥ 6 months old up to 6 years old).1,2 The company will also feature studies on a pandemic adjuvanted, cell-based H5N1 vaccine that examined immune responses against heterologous A (H5N1) strains in young children (6 months to ≤ 17 years old), adults (18 to < 65 years) and elderly populations (65 years and older), as well as a retrospective analysis on the level of antigenic similarity of cell-based versus egg-based influenza vaccine reference strains and circulating influenza B viruses.3,4,5

“As a company on the front line of influenza prevention, we are committed to developing innovative technologies, like adjuvanted and cell-based vaccines, to help improve influenza prevention,” said Russell Basser, MD, Chief Scientist and Senior Vice President of Research and Development at Seqirus. “We look forward to sharing our latest data at OPTIONS X and continuing to develop our broad portfolio of vaccines to help reduce the burden of disease caused by influenza.”

Seqirus Presentations and Posters at OPTIONS X

To view the program online, please visit: https://2019.isirv.org/scientific-programme

Pandemic Influenza

  • Antibody Responses Against Heterologous H5N1 Strains for an MF59®-Adjuvanted Cell Culture-Derived H5N1 (aH5N1c) Influenza Vaccine in Healthy Pediatric Subjects (E. Versage, M. Hohenboken)
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT
  • Antibody Responses Against Heterologous H5N1 Strains for an MF59®-Adjuvanted Cell Culture-Derived H5N1 (aH5N1c) Influenza Vaccine in Adults and the Elderly (E. Versage, M. Hohenboken)     
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT
  • Immunogenicity, Lot-To-Lot Consistency, and Safety of an MF59®-Adjuvanted Cell Culture-Derived H5N1 (aH5N1c) Influenza Vaccine in Healthy Adults (E. Versage, M. Hohenboken)     
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT
  • Reference Antigen-Free and Antibody-Free LTD-IDMS Quantifies A(H5N1) Vaccine Potency (E. Settembre, Y. Wen)
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT

Seasonal Influenza

  • MF59®-Adjuvanted Quadrivalent Influenza Vaccine Provides Consistent Benefit Upon Revaccination in Young Children (I. Smolenov, J. Oberyé)
        Session Date & Time: August 28, 2019, 6:45 – 7:30 pm SGT
  • Adjuvanted Vaccine Induced Higher Strain Cross-Reactive Antibody Response than Non-Adjuvanted Vaccine (E. Settembre, Y. Wen)
        Session Date & Time: August 30, 2019, 6:00 – 7:30 pm SGT
  • Retrospective Evaluation of Antigenic Similarity Between Egg-Derived Versus Cell-Derived Influenza Vaccine Reference Strains and Circulating Influenza B-Victoria and Yamagata Viruses (S. Rajaram)
        Session Date & Time: August 31, 2019, 5:30 – 7:00pm SGT
  • Reduced Vaccine Effectiveness Resulting from Candidate Influenza Virus Variation During Egg-Based Manufacture: Literature Review and Expert Survey (S. Rajaram) 
        Session Date & Time: August 31, 2019, 5:30 – 7:00pm SGT
  • Prevention of Influenza during Mismatched Seasons in Older Adults: A Randomized Efficacy Study of an MF59®-Adjuvanted Quadrivalent Influenza (I. Smolenov, C. Fierro)
        Session Date & Time: August 31, 2019, 10:30 am – 12:30 pm SGT
  • MF59®-Adjuvanted Quadrivalent Subunit Influenza Vaccine is Non-Inferior to the Licensed MF59-Adjuvanted Trivalent Vaccine and Well-Tolerated in Older Adults (I. Smolenov, C. Fierro)
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT
  • The Economic Advantages of a Cell-Based Quadrivalent Influenza Vaccine in the Adult Population in Europe. The Cost-Effectiveness Evidence in United Kingdom and Spain (V. H. Nguyen, S. Márquez-Peláez, J. Ruiz-Aragón)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Effectiveness of Risk Minimisation Activities for Afluria® Quad Through an Online Survey - A Quantitative Research Study (H. Shetty)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Effectiveness of an Independent, Online Educational Program for Australian Healthcare Professionals on Seasonal Influenza Immunisation Strategies in Older Adults in 2018 (M. Tham)
        
    Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Afluria® Quadrivalent Influenza Vaccine for Adults and Paediatric Use (F. R. Albano)
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT
  • Assessing Factors Influencing Influenza Vaccine Choice in U.S. Nursing Homes (J. Mansi, S. Gravenstein)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Evaluation of Influenza Case Definitions in a Primary Care Database for Use in Real World Evidence Research (J. Mansi, T. Boikos)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Influenza Vaccine Programs with the Cell-Based Quadrivalent Influenza Vaccine are Highly Effective in Canada (J. Mansi, T. Boikos)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Strengthening Pediatric Influenza Vaccination Offering and Acceptance: Findings from the Pediatric Influenza Vaccination Optimization Trial (PIVOT) (J. Mansi, T. Boikos)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Real World Outcomes of Adjuvanted Trivalent Influenza Vaccine Compared to Egg-Based Trivalent High-Dose, Egg-Based Quadrivalent and Trivalent Vaccines Among the U.S. Elderly During 2016-2018 Flu Seasons Using Claims Data (V. Divino, M. Jiang, M. DeKoven)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Hospitalization Encounters Following Vaccination with Adjuvanted Trivalent Influenza Vaccine Compared to Egg-Based Trivalent High-Dose, Egg-Based Quadrivalent and Trivalent Vaccines Among the U.S. Elderly Using Claims Data (V. Divino, M. Jiang, M. DeKoven)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Method for Determining Percentage Split Virion by Nanosight (C. Ong)     
        Session Date & Time: August 30, 2019, 6:00 – 7:30 pm SGT
  • EIA Hemagglutinin Potency Assay: An Alternative to SRID (J. Bodle, S. Rockman)
        Session Date & Time: August 30, 2019, 6:00 – 7:30 pm SGT
  • Use of a Biological Assay to Mitigate Vaccine Pyrogenicity (C. Ong)
        Session Date & Time: August 30, 2019, 6:00 – 7:30 pm SGT
  • First International Workshop on Reassortment of Influenza Candidate Vaccine Viruses (C. Wadey)
        Session Date & Time: August 31, 2019, 5:30 – 7:00 pm SGT
  • Practical Implementation of Cell Isolated Candidate Vaccine Viruses for Large Scale, Cell-Based Influenza Vaccine Manufacture (K. Kulowiec)
        Session Date & Time: August 30, 2019, 6:00 – 7:30 pm SGT
  • Microneutralization Assay Titers as Estimates of Protective Efficacy Against Influenza Infection in Children (M. Heeringa)
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT
  • Improved Pyrogenicity (Fever) Profile of Quadrivalent Inactivated Influenza Vaccine (D. Sawlwin) 
        Session Date & Time: August 28, 2019, 6:30 – 7:30 pm SGT

 

AFLURIA® QUADRIVALENT (Influenza Vaccine) Important Safety Information


Indication
AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in individuals 5 years of age and older.

Contraindications

  • Severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.

Warnings and Precautions

  • If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
  • Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
  • Immunocompromised persons may have a diminished immune response to AFLURIA QUADRIVALENT

Adverse Reactions

  • In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%).
  • In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).
  • In children 5 through 8 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse event was headache (≥10%).
  • In children 9 through 17 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥10%).

The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:

  • In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%).

Please see full prescribing information for AFLURIA QUADRIVALENT.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Seqirus
Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 22,000 people with operations in more than 60 countries.

Seqirus was established on 31 July 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. 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. Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.

About CSL
CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia 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 lifesaving products to more than 60 countries and employs more than 22,000 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.

MF59® is a registered trademark of Novartis International AG, Basel, Switzerland.

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

All other trademarks referenced herein are property of their respective owners.

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 contains 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.

US/CORP/0819/0159

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MEDIA CONTACT

Polina Miklush
+1 (908) 608-7170
Polina.Miklush@seqirus.com

REFERENCES
1 Vesikari T, Ramsey K, Oberyé, et al. (2019). MF59®-adjuvanted quadrivalent influenza vaccine provides consistent benefit upon revaccination in young children. Presented at OPTIONS X, August 2019.
2  Palladino G, Ferrari A, Ferdman J, et al. (2019). Adjuvanted vaccine induced higher strain cross-reactive antibody response than non-adjuvanted vaccine. Presented at OPTIONS X, August 2019.
3  Chanthavanich P, Versage E, Van Twuijver E, et al. (2019). Antibody responses against heterologous H5N1 strains for an MF59®-adjuvanted cell culture-derived H5N1 (aH5N1c) influenza vaccine in healthy pediatric subjects. Presented at OPTIONS X, August 2019.
4  Frey S, Versage E, Van Twuijver E, et al. (2019). Antibody responses against heterologous H5N1 strains for an MF59®-adjuvanted cell culture-derived H5N1 (aH5N1c) influenza vaccine in adults and the elderly. Presented at OPTIONS X, August 2019.
5  Rajaram S., P. Suphaphiphat, M. Haag, et al. (2019). Retrospective evaluation of antigenic similarity between egg-derived Versus cell-derived influenza vaccine reference strains and circulating influenza B-Victoria and Yamagata viruses. Presented at OPTIONS X, August 2019.