CSL Seqirus, a global leader in pandemic preparedness, announces 6th BARDA Award in response to avian influenza

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

summit new jersey, October 4, 2024 /PRNewswire/ — CSL Seqirus, a CSL (ASX: CSL) business, has been selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of State's Office of Strategic Preparedness and Response (ASPR). The Department of Health and Human Services (HHS) will complete additional pre-pandemic vaccinations as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS). This latest acquisition of pre-pandemic vaccines will further complement BARDA's vaccine stockpile 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 underscores the value of collaboration in tackling emerging global health threats,” he said. mark laceyGlobal Executive Director, Pandemic, CSL Seqirus. “We are a pandemic partner to more than 30 governments around the world and are proud to help protect and protect public health.”

Based on the terms of $34 million With the award, CSL Seqirus will deliver approximately 3 million doses of the completed MF59.^®-Produce adjuvanted H5N1 pre-pandemic vaccines and additional lots of H5N8 antigen. Evidence produced by the CDC indicates that both the H5N1 and H5N8 strains are similar to the A(H5N1) strain circulating among dairy cows in the United States, and that both strains are present in vaccinated individuals. This suggests that it can be expected to have some degree of protective effect.^{1, 2}

“Pandemic preparedness is at the core of who we are,” he said. John Kegelisvice president of manufacturing and site director for CSL Seqirus Holly Springs. “Our Holly Springs site was built to deliver innovative pandemic solutions at industrial scale and speed.”

CSL Seqirus manufacturing facility Holly Springs, North CarolinaBuilt through a public-private partnership established with BARDA in 2009, the company is the world's largest cell-based influenza vaccine manufacturer and the first such domestic facility in the United States, with highly scalable production methods. Currently, 150 million doses of influenza vaccine will be administered to support the influenza pandemic response within six months of the pandemic declaration. After this, a second wave of manufacturing could be possible to provide further pandemic vaccines if needed. Seasonal vaccine production requires ongoing research and development targeting influenza strains with pandemic potential, stockpiles of ingredients and raw materials, seed libraries, and technological know-how to manufacture at scale in preparation for a pandemic. In parallel with the activity, it provides an important “warm base”.

This project is supported in whole or in part by federal funds from the Department of Health and Human Services. Management for strategic preparedness and response. Biomedical Advanced Research and Development Authority (BARDA) under contracts HHSO100200900101C and 75A50122D00004.

About new influenza
Influenza is an airborne respiratory disease.^3,4 The risk of influenza-associated morbidity and mortality is higher for pandemic influenza than for seasonal influenza because there is likely little or no pre-existing immunity to the novel virus in the human population.⁵ The timing and severity of new influenza outbreaks cannot be predicted. There have been four influenza pandemics in the past 100 years, but the 1918 pandemic was the most severe in recent history, estimated to cause up to 50 million deaths worldwide. .⁶

About avian influenza
Avian influenza primarily spreads among birds.⁷ Avian influenza viruses usually do not infect humans. However, in rare cases, humans can become infected with the avian influenza virus.⁸ The severity of human illness from avian influenza varies from asymptomatic or mild symptoms to severe illness and death.⁸ Avian influenza is very rarely transmitted from person to person and usually only infects a small number of people.⁸

The recent increase in avian influenza in birds is caused by highly pathogenic avian influenza (HPAI) A(H5N1) viruses.⁹ CSL Seqirus recommends referring to WHO statements, CDC, ECDC, or national guidance to determine the level of concern regarding high-level HPAI activity.^{10, 11, 12}

About CSL Sekirus
CSL Sekirus is part of CSL (ASX:CSL). As a global leader in public health protection and one of the world's largest influenza vaccine providers, CSL Seqirus is committed to preventing infectious diseases such as influenza and COVID-19. A transcontinental partner in pandemic preparedness. We have state-of-the-art production facilities in the United States, the United Kingdom, and the United States. Australiaand state-of-the-art research and development capabilities, CSL Seqirus offers a broad portfolio of innovative and differentiated vaccines to more than 20 countries around the world.

For more information about CSL Seqirus, please visit: CSL.com.

About CSL
CSL(ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of medicines, including treatments for hemophilia and immunodeficiency, vaccines to prevent influenza, and treatments for iron deficiency and kidney disease. is. Since our founding in 1916, we've been driven by a promise to save lives using the latest technology. Today, CSL serves patients in more than 100 countries and employs 32,000 people, including its three businesses: CSL Behring, CSL Seqirus and CSL Vifor. Our unique combination of commercial strength, research and development focus and operational excellence allows us to identify, develop and deliver innovations that help patients live their fullest lives. For inspiring stories about the possibilities of biotechnology, visit:CSL.com/we-are-csl/vita-original-storiesand follow usTwitter.com/CSL. For more information about CSL, please visit:www.CSL.com.

Target audience
This press release is published by CSL Seqirus. summit, new jerseyUnited States, and is intended to provide information about our global business. Please note that information regarding the approval status and labeling of approved CSL Seqirus products may vary by country. Please contact your local regulatory authority for the approval status of CSL Seqirus products.

Forward-looking statements
This press release may contain forward-looking statements, including statements regarding future results, performance and achievements. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. There are other factors that may cause the difference. These statements reflect the Company's current views regarding future events, are based on assumptions and are 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). Latest technology information: Summary analysis of the genetic sequence of highly pathogenic avian influenza A (H5N1) virus 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) virus. Retrieved from https://www.cdc.gov/bird-flu/php/technical-report/h5n1-06052024.html. Accessed September 2024
³ CDC. About influenza. Retrieved from: https://www.cdc.gov/flu/about/index.html. Accessed September 2024
⁴ CDC. Important facts about influenza (influenza). Retrieved from: https://www.cdc.gov/flu/keyfacts_1.htm. Accessed September 2024
⁵ Who? How does a new type of influenza occur? 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. Information about avian influenza and avian influenza. Retrieved from: https://www.cdc.gov/flu/avianflu/index.htm. Accessed September 2024
⁸ CDC. What causes the avian influenza virus to infect 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) viruses in animals: interim recommendations. Retrieved from: https://www.cdc.gov/bird-flu/prevention/hpai-interim-recommendations.html. Accessed September 2024
¹⁰ CDC. H5 Avian Influenza: Current Status. Retrieved from: https://www.cdc.gov/bird-flu/situation-summary/index.html. Accessed September 2024
¹¹FAO, WHO, wow. Outbreaks of avian influenza in animals continue and pose a risk to humans. Retrieved from: https://www.fao.org/animal-health/news-events/news/detail/oncoming-avian-influenza-outbreaks-in-animals-pose-risk-to-humans/en. Accessed September 2024
¹²European Center for Disease Prevention and Control (ECDC). Bird Influenza Overview March – June 2024. Retrieved from: https://www.ecdc.europa.eu/en/publications-data/avian-influenza-overview-march-june-2024. Accessed September 2024

Source CSL Sekirus