CSL Seqirus, a business of CSL (ASX: CSL), announced today that through its public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), the company will expand its Vendor Managed Inventory (VMI) program for its proprietary MF59® adjuvant. This decision will further support the U.S. government’s pandemic preparedness efforts.
MF59® adjuvant is an important part of pandemic preparedness planning as it reduces the amount of antigen required to produce an immune response, increasing the number of vaccine doses.1,2 When combined with influenza antigens in a vaccine, MF59® adjuvant is designed to enhance and broaden the body’s immune response by creating a broad, cross-reactive antibody response.3,4,5
“Once again, we’re honored to partner with BARDA on pandemic preparedness,” said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic. “This expanded program will increase outbreak resilience and help to protect against threats such as avian influenza.”
Under the terms of the $121.4 million multi-year award, CSL Seqirus will deliver MF59® adjuvant to increase the inventory of the VMI program to 40 million equivalent doses. MF59® will be manufactured at CSL Seqirus’ Holly Springs, North Carolina facility, which was built under a long-term public-private partnership with BARDA to provide domestic influenza pandemic preparedness. MF59® from the VMI program can be used to manufacture vaccines to protect against the threat of avian and other strains of influenza. This is the fifth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza (HPAI) activity.
According to the Centers for Disease Control and Prevention (CDC), avian influenza A(H5) virus is widespread in wild birds around the world and is causing multistate outbreaks in poultry and U.S. dairy cows.6,7 Several human cases of avian influenza A(H5) virus infection have also been reported in the U.S.6,7 While the current public health risk is low, the CDC continues to watch the situation carefully and work with states to monitor people with animal exposures.6,7
“Pandemics are a natural phenomenon and have occurred at infrequent and unpredictable intervals throughout human history, presenting a real and serious risk to public health,” said Dave Ross, General Manager of CSL Seqirus. “Recent avian influenza outbreaks underscore the importance of pandemic preparedness. With this expanded award, BARDA is once again entrusting us to work in collaboration to protect public health.”
The VMI program has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract HHSO100200900101C.
About Pandemic Influenza
Influenza is a contagious airborne respiratory disease.8,9 The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the novel virus in the human population.10 The timing and severity of pandemic influenza is unpredictable. Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, with an estimated mortality of up to 50 million people worldwide.11
About Avian Influenza
Avian influenza spreads predominantly among birds.12 Avian influenza viruses do not normally infect humans, however, in rare cases humans have been infected with avian influenza viruses.13 Illness in humans from avian influenza has varied in levels of severity, from no symptoms or mild illness to severe disease and death.13 The spread of avian influenza from one human to another is very rare and typically has only spread to a few people.13
The recent rise in avian influenza among birds has been driven by highly pathogenic avian influenza (HPAI) A(H5N1).14 CSL Seqirus recommends referring to the WHO statement, and CDC, ECDC or national guidance to gauge the levels of concern regarding the high levels of HPAI activity.6,15,16
About CSL Seqirus
CSL Seqirus is part of CSL (ASX:CSL). As one of the largest influenza vaccine providers in the world, CSL 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, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
For more information about CSL Seqirus, visit CSL.com.
About CSL
CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides products to patients in more than 100 countries and employs 32,000 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 inspiring stories about the promise of biotechnology, visit CSL.com/we-are-csl/vita-original-stories and follow us on x.com/CSL. For more information about CSL, visit www.CSL.com.
Intended Audience
This press release is issued from CSL Seqirus 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 CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL 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.
MEDIA CONTACT
Em Dekonor
+44 (0)7920500496
Emmanuella.Dekonor@seqirus.com
References
1 Khurana, S, Verma, N, Yewdell, JW, et al. (2011) MF59 adjuvant enhances diversity and affinity of antibody-mediated immune response to pandemic influenza vaccines. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501657/. [Accessed September 2024]
2 Reed, SG, Orr, MT, Fox, CB. (2013). Key roles of adjuvants in modern vaccines. Retrieved from: https://www.nature.com/articles/nm.3409. [Accessed September 2024]
3 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034
4 O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-3
5 Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. (2008). MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249
6 The Centers for Disease Control and Prevention (CDC). H5 Bird Flu: Current Situation. Retrieved from: https://www.cdc.gov/bird-flu/situation-summary/index.html. [Accessed September 2024]
7 CDC. CDC A(H5N1) Bird Flu Response Update September 13, 2024. Retrieved from: https://www.cdc.gov/bird-flu/spotlights/h5n1-response-09132024.html. [Accessed September 2024]
8 CDC. About Flu. Retrieved from: https://www.cdc.gov/flu/about/index.html. [Accessed September 2024]
9 CDC. Key Facts About Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. [Accessed September 2024]
10 WHO. How pandemic influenza emerges. Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/how-pandemic-influenza-emerges. [Accessed September 2024]
11 WHO. Pandemic Influenza Risk Management: A WHO guide to inform and harmonize national and international pandemic preparedness and response. Retrieved from: https://apps.who.int/iris/bitstream/handle/10665/259893/WHO-WHE-IHM-GIP-2017.1-eng.pdf;jsessionid=4421F16879D2F8B96481F8D0C745C7F3?sequence=1. [Accessed September 2024]
12 CDC. Avian Flu, Information on bird flu. Retrieved from: https://www.cdc.gov/flu/avianflu/index.htm. [Accessed September 2024]
13 CDC. What Causes Bird Flu Virus Infections in Humans. Retrieved from: https://www.cdc.gov/bird-flu/virus-transmission/avian-in-humans.html. [Accessed September 2024]
14 CDC. Highly Pathogenic Avian Influenza A(H5N1) Virus in Animals: Interim Recommendations. Retrieved from: https://www.cdc.gov/bird-flu/prevention/hpai-interim-recommendations.html. [Accessed September 2024]
15 FAO, WHO, WOAH. Ongoing avian influenza outbreaks in animals pose risk to humans. Retrieved from: https://www.fao.org/animal-health/news-events/news/detail/ongoing-avian-influenza-outbreaks-in-animals-pose-risk-to-humans/en. [Accessed September 2024]
16 European Centre for Disease Prevention and Control (ECDC). Avian influenza overview March – June 2024. Retrieved from: https://www.ecdc.europa.eu/en/publications-data/avian-influenza-overview-march-june-2024 [Accessed September 2024]