Summit, NJ – August 30, 2019
Seqirus, a global leader in influenza prevention, today presented data at the Options for the Control of Influenza (OPTIONS X) Conference in Singapore from clinical studies demonstrating the ability of a MF59® adjuvanted influenza vaccine to increase immune responses when used in both seasonal and pandemic influenza vaccines, across pediatric and adult populations.,,,
An adjuvant such as MF59® is added to an influenza vaccine with the intended purpose of creating a strong, broad, and durable immune response. As detailed in the data presentations today, a quadrivalent, adjuvanted seasonal influenza vaccine:
- Induced a higher immune response upon two revaccination studies as demonstrated for both homologous and heterologous strains in children (6 months to 72 months old) compared to a non-adjuvanted influenza vaccine1
- Produced a greater magnitude of cross-reactive antibody responses compared to a non-adjuvanted influenza vaccine in children with lower preexisting antibody titers, regardless of age (6 months through 23 months old or 36 months through 71 months old) or vaccination history2
The studies were conducted during influenza seasons characterized by antigenic drift, or small genetic mutations that accumulate in the circulating virus over time, in the influenza A (H3N2) strain.,,9 Antigenic drift can cause a strain mismatch between the circulating virus and the influenza vaccine virus strains designated by the World Health Organization (WHO).6, Adjuvanted influenza vaccines have demonstrated the ability to enhance the production of immune cells in the body and generate more cross-reactive antibodies against influenza virus strains that have mutated, compared to non-adjuvanted standard dose vaccine.1,2,,
“These studies show that the use of MF59® adjuvant technology can broaden the immune response against influenza viruses,” said Russell Basser, MD, Chief Scientist and Senior Vice President of Research and Development at Seqirus. “At Seqirus, we’re dedicated to researching and developing vaccines designed to transform approaches to influenza prevention.”
MF59® adjuvanted seasonal influenza vaccines have a demonstrated safety profile, with more than 100 million doses distributed since the trivalent formulation was first licensed in 1997.
MF59® adjuvant, combined with a cell-based pandemic influenza A (H5N1) vaccine candidate, was found to induce antibodies that may enhance the immune response against heterologous A (H5N1) strains.3,4 In the presented clinical studies that examined a first-of-its-kind A (H5N1) adjuvanted, cell-based pandemic influenza vaccine, results showed:
- Increased immune responses against heterologous A (H5N1) strains in adults (18 to < 65 years old) and the elderly (≥ 65 years of age) with a full-dose vaccination (7.5 μg hemagglutinin (HA) of H5N1 with 0.25 mL MF59® for a total injection volume of 0.5 mL)3,
- Increased immune responses against heterologous A (H5N1) strains in children (6 months to £ 17 years old) with a full-dose vaccination (7.5 μg hemagglutinin (HA) of H5N1 with 0.25 mL MF59® for a total injection volume of 0.5 mL)4,14
Influenza A (H5N1) viruses have high pandemic potential; therefore, vaccines need to be rapidly produced when these strains emerge.15 Pandemic influenza vaccines with MF59® adjuvant require less antigen per vaccine dose compared to most seasonal formulations, allowing for more rapid vaccine availability., MF59® adjuvanted vaccine is an important part of pandemic preparedness planning as it has been shown to generate high levels of cross-reactive antibodies against five separate genetic clades of A (H5N1) virus in both pediatric and adult populations, highlighting the potential public health benefits of pandemic vaccine stockpiling.3,4,15
“The data presented at OPTIONS X complement previous clinical studies that emphasize the important role of innovative technologies, such as the MF59® adjuvant, in broadening and enhancing the immune response against evolving seasonal and pandemic influenza viruses,” said Anjana Narain, Executive Vice President at Seqirus. “As part of our role on the front line of influenza prevention, we’re committed to developing advanced technologies and vaccines that can help provide seasonal protection as well as provide a rapid production response during a pandemic outbreak.”
An influenza pandemic requires rapid production of very large quantities of vaccine, and Seqirus has the capability to enhance vaccine production by using cell-based vaccine manufacturing in the event of a pandemic as a result of its public-private partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA)., , The U.S. Food and Drug Administration (FDA) recently accepted the Biologics License Application (BLA) for the first ever adjuvanted, cell-based influenza vaccine against the influenza A (H5N1) strain.13
About the Studies
Pandemic influenza, as with seasonal influenza, is a contagious airborne respiratory disease which is unpredictable and can occur in any age group or any population worldwide. The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because of little or no pre-existing immunity to the virus in the human population. Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide.
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.
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 life-saving 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.
Palladino G, Ferrari A, Ferdman J, et al. (2019). Vaccination with adjuvanted vaccine induced higher strain cross-reactive antibody response than non-adjuvanted vaccine. Presented at OPTIONS X, August 2019.
Frey S, Versage E, Van Twuijver E, et al. (2019). Antibody responses against heterologous H5N1 strains for a MF59®-adjuvanted cell culture-derived H5N1 (aH5N1c) influenza vaccine in adults and the elderly. Presented at OPTIONS X, August 2019.
Chanthavanich P, Versage E, Van Twuijver E, et al. (2019). Antibody responses against heterologous H5N1 strains for an MF59®-adjuvanted cell culture-derived H5N1c (aH5N1c) influenza vaccine in healthy pediatric subjects. Presented at OPTIONS X, August 2019.
CDC. (2018). Adjuvants help vaccines work better. Retrieved from: https://www.cdc.gov/vaccinesafety/concerns/adjuvants.html Accessed July 2019.
CDC (2017) How the Flu Virus Can Change: “Drift” and “Shift.” Retrieved from: https://www.cdc.gov/flu/about/viruses/change.htm. Accessed August 2019.
Zost, S. J., Parkhouse, K., Gumina, M. E., Kim, K., Diaz Perez, S., Wilson, P. C., … Hensley, S. E. (2017). Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. Proceedings of the National Academy of Sciences, 114(47), 12578–12583. https://doi.org/10.1073/pnas.1712377114
Darvishian, M., Dijkstra, F., van Doorn, E., Bijlsma, M. J., Donker, G. A., de Lange, M. M. A., … Meijer, A. (2017). Influenza Vaccine Effectiveness in the Netherlands from 2003/2004 through 2013/2014: The Importance of Circulating Influenza Virus Types and Subtypes. PLOS ONE, 12(1), e0169528. https://doi.org/10.1371/journal.pone.0169528
Chambers, B. S., Parkhouse, K., Ross, T. M., Alby, K., & Hensley, S. E. (2015). Identification of Hemagglutinin Residues Responsible for H3N2 Antigenic Drift during the 2014–2015 Influenza Season. Cell Reports, 12(1), 1–6. https://doi.org/10.1016/j.celrep.2015.06.005
Vemula, S. V., Sayedahmed, E. E., Sambhara, S., & Mittal, S. K. (2017). Vaccine approaches conferring cross-protection against influenza viruses. Expert review of vaccines, 16(11), 1141–1154. doi:10.1080/14760584.2017.1379396
Frey, S. E., Shakib, S., Chanthavanich, P., Richmond, P., Smith, T., Tantawichien, T., … Hohenboken, M. (2019). Safety and Immunogenicity of MF59-Adjuvanted Cell Culture–Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly. Open Forum Infectious Diseases, 6(4). https://doi.org/10.1093/ofid/ofz107
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 and HHSO100200900101C.
CCOHS (Canadian Centre for Occupational Health and Safety). Pandemic Influenza (Flu). Retrieved from: https://www.ccohs.ca/oshanswers/diseases/pandemic_flu.html. Accessed August 2019.
CDC (2018). Key Facts About Influeza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed August 2019.
CDC (2018) Key Facts About Seasonal Flu Vaccine. Retrieved from: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed August 2019.
CDC (2018). Estimated Influenza Illnesses, Medical Visits, Hospitalizations, and Deaths in the United States – 2017 – 2018 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2017-2018.htm. Accessed August 2019.