CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Sixth BARDA Award in Response to Avian Influenza

• CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government's outbreak and preparedness response. 
• BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines.
• This $34 million investment is the sixth avian influenza pandemic preparedness award made to CSL Seqirus by BARDA. 

SUMMIT, N.J., Oct. 4, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), has been selected by 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), to fill and finish additional pre-pandemic vaccine doses as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). This latest acquisition of pre-pandemic vaccine will further supplement BARDA's stockpile of vaccine to support the U.S. government's pre-pandemic response to avian influenza. 

"As a global leader in pandemic preparedness, this new award from BARDA emphasizes the value of collaboration in tackling global health threats as they emerge," said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic. "We're proud to be a pandemic partner to over thirty governments globally and to do our part to help safeguard and protect public health."

Under the terms of the $34 million award, CSL Seqirus will deliver approximately 3 million finished doses of MF59^®-adjuvanted H5N1 pre-pandemic vaccine and manufacture an additional lot of H5N8 antigen. Evidence produced by the CDC indicates both the H5N1 strain and the H5N8 strain are similar to A(H5N1) strains circulating among U.S. dairy cattle and suggests that both strains could be expected to induce a degree of protection in vaccinated individuals.^1,2

"Pandemic preparedness is a core part of who we are," said Jon Kegerise, Vice President of Manufacturing and Site Head at CSL Seqirus Holly Springs. "Our Holly Springs site was built to be able to deliver innovative pandemic solutions at industrial scale and speed."

CSL Seqirus' manufacturing facility in Holly Springs, North Carolina, built through a public-private partnership established in 2009 with BARDA, is the largest cell-based influenza vaccine producer in the world and is the first such domestic facility in the U.S. It utilizes a highly scalable method of production and is currently positioned to deliver 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration. After this, a second wave of manufacturing could be enabled to provide further pandemic vaccine as needed. Seasonal vaccine manufacturing provides an essential "warm base" alongside ongoing R&D activity with influenza strains of pandemic potential, component and raw material stockpiles, seed libraries and technological know-how to be pandemic ready and manufacture at scale. 

This project 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 contracts HHSO100200900101C and 75A50122D00004. 

About Pandemic Influenza
Influenza is a contagious airborne respiratory disease.^3,4 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.⁵ 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.⁶

About Avian Influenza
Avian influenza spreads predominantly among birds.⁷ Avian influenza viruses do not normally infect humans; however, in rare cases humans have been infected with avian influenza viruses.⁸ Illness in humans from avian influenza has varied in levels of severity, from no symptoms or mild illness to severe disease and death.⁸ The spread of avian influenza from one human to another is very rare and typically has only spread to a few people.⁸

The recent rise in avian influenza among birds has been driven by highly pathogenic avian influenza (HPAI) A(H5N1) virus.⁹ 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.^10,11,12

About CSL Seqirus
CSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is 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 offers a broad portfolio of innovative, differentiated 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 Twitter.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.

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¹ Centers for Disease Control and Prevention (CDC). Technical Update: Summary Analysis of Genetic Sequences of Highly Pathogenic Avian Influenza A(H5N1) Viruses in Texas. Retrieved from https://www.cdc.gov/bird-flu/spotlights/h5n1-analysis-texas.html. Accessed September 2024
² CDC. Technical Report: June 2024 Highly Pathogenic Avian Influenza A(H5N1) Viruses. Retrieved from https://www.cdc.gov/bird-flu/php/technical-report/h5n1-06052024.html. Accessed September 2024
³ CDC. About Flu. Retrieved from: https://www.cdc.gov/flu/about/index.html. Accessed September 2024
⁴ CDC. Key Facts About Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/keyfacts_1.htm. Accessed September 2024
⁵ WHO. How pandemic influenza emerges. Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/how-pandemic-influenza-emerges. Accessed September 2024
⁶ 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
⁷ CDC. Avian Flu, Information on bird flu. Retrieved from: https://www.cdc.gov/flu/avianflu/index.htm. Accessed September 2024
⁸ 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
⁹ 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
¹⁰ CDC. H5 Bird Flu: Current Situation. Retrieved from: https://www.cdc.gov/bird-flu/situation-summary/index.html. Accessed September 2024
¹¹ 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
¹² 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

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