CSL Seqirus, a Proud Champion of Pandemic Preparedness, Announces U.S. Government Award in Response to Avian Influenza

Rhea-AI Summary

CSL Seqirus has been awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to produce 4.8 million doses of pre-pandemic H5N1 vaccine for the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. This is the fourth such award for CSL Seqirus, reinforcing its role in pandemic preparedness. The company's Holly Springs, NC facility, built through a public-private partnership with BARDA, can produce up to 150 million doses within six months of a pandemic declaration. The facility is the largest cell-based influenza vaccine producer globally.

Positive

• Awarded a contract to produce 4.8 million doses of H5N1 vaccine.
• Fourth award from BARDA for pandemic preparedness.
• Facility can deliver up to 150 million doses within six months of a pandemic.
• Largest cell-based influenza vaccine producer in the world.
• Public-private partnership supporting pandemic preparedness.

Negative

• Potential risk if the current avian flu situation changes.
• Dependency on government contracts for pandemic preparedness activities.
• Significant reliance on one manufacturing facility for large-scale production.

• CSL Seqirus to complete the fill and finish process for pre-pandemic vaccine to support the U.S. government's outbreak and preparedness response.
• Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and livestock have been reported in the U.S.
• Fourth avian influenza pandemic preparedness award to CSL Seqirus under a multi-year agreement with Biomedical Advanced Research and Development Authority (BARDA).

SUMMIT, N.J., May 30, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), was 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 complete the fill and finish process of pre-pandemic vaccine for the U.S. government as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program. This acquisition of pre-pandemic vaccine will increase BARDA's stockpile of vaccine to support the U.S. government's pre-pandemic response.

"The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners," said Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic. "This agreement, building upon prior agreements with BARDA, will help support the U.S. government's ability to respond swiftly in the event that the current avian flu situation changes."

Under the terms of the agreement, CSL Seqirus will deliver approximately 4.8 million doses of pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain. This is the fourth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza (HPAI) activity.

"As a global leader and proud champion of pandemic preparedness, CSL Seqirus welcomes the BARDA award to fill-finish and deliver pre-pandemic vaccine," said Dave Ross, General Manager of CSL Seqirus. "Alongside our partners, we embrace pandemic preparedness as a critical part of public health protection, and understand that together with surveillance and testing, vaccine protection provides pandemic preparedness reassurance to governments and populations alike."

CSL Seqirus' manufacturing facility in Holly Springs, NC, 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. It utilizes a highly scalable method of production and is currently positioned to deliver up to 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 contract numbers HHSO100200900101C and 75A50122D00004.

About Pandemic Influenza
Influenza is a contagious airborne respiratory disease.^1,2 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.³ The timing and severity of pandemic influenza is unpredictable.⁴ 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.⁴ Strain-matched pandemic influenza vaccines are manufactured in response to the declaration of a pandemic.⁵ Pre-pandemic (also called zoonotic) influenza vaccines are available in the inter-pandemic period to help protect against influenza strains with pandemic potential; these vaccines can be deployed under government guidance to mitigate the risk of an outbreak or provide a first line of defense in advance of a pandemic vaccine if a pandemic were to be declared.⁵

About Avian Influenza
Avian influenza is an infectious type of influenza that spreads predominantly among birds.⁶ Avian influenza viruses do not normally infect humans, however, in rare cases humans have been infected with avian influenza viruses.⁷ Illness in humans from avian influenza has varied in levels of severity, from no symptoms or mild illness to severe disease and death.⁷ The spread of avian influenza from one human to another is very rare and typically has only spread to a few people.⁷

The recent rise in avian influenza among birds has been driven by highly pathogenic avian influenza (HPAI) A(H5N1).⁸ 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.^8,9,10

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 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. 

MEDIA CONTACT
Em Dekonor
+44 (0)7920500496
Emmanuella.Dekonor@seqirus.com 

USA-PAN-24-0001

¹ Centers for Disease Control and Prevention (CDC). Pandemic Basics. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/index.html. [Accessed May 2024]

² CDC. Key Facts About Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. [Accessed May 2024]

³ WHO. How pandemic influenza emerges. Retrieved from: https://www.who.int/europe/news-room/fact-sheets/item/how-pandemic-influenza-emerges. [Accessed May 2024]

⁴ 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 May 2024]

⁵ European Medicines Agency (EMA). Vaccines for pandemic influenza. Retrieved from: https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/pandemic-influenza/vaccines-pandemic-influenza. [Accessed May 2024]

⁶ CDC. Avian Flu, Information on bird flu. Retrieved from:  https://www.cdc.gov/flu/avianflu/index.htm. [Accessed May 2024]

⁷ CDC. Avian Flu, Bird Flu Virus Infections in Humans. Retrieved from:  https://www.cdc.gov/flu/avianflu/avian-in-humans.htm. [Accessed May 2024]

⁸ CDC. H5N1 Bird Flu: Current Situation Summary. Retrieved from: https://www.cdc.gov/flu/avianflu/avian-flu-summary.htm. [Accessed May 2024]

⁹ WHO. Ongoing avian influenza outbreaks in animals pose risk to humans. Retrieved from: https://www.who.int/news/item/12-07-2023-ongoing-avian-influenza-outbreaks-in-animals-pose-risk-to-humans. [Accessed May 2024]

¹⁰ European Centre for Disease Prevention and Control (ECDC). Avian influenza overview April – June 2023. Retrieved from: https://www.ecdc.europa.eu/en/publications-data/avian-influenza-overview-april-june-2023. [Accessed May 2024]

 

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SOURCE CSL Seqirus

FAQ

What is the recent contract CSL Seqirus received related to?

CSL Seqirus received a contract from BARDA to produce 4.8 million doses of pre-pandemic H5N1 vaccine.

How many doses of pre-pandemic vaccine will CSL Seqirus deliver under the new BARDA contract?

CSL Seqirus will deliver approximately 4.8 million doses.

What strain is the CSL Seqirus pre-pandemic vaccine matched to?

The vaccine is well-matched to the H5 of the currently circulating H5N1 strain.

How many pandemic influenza vaccine doses can CSL Seqirus' facility produce?

The facility can produce up to 150 million doses within six months of a pandemic declaration.

Is this CSL Seqirus' first contract with BARDA?

No, this is the fourth award CSL Seqirus has received from BARDA related to avian influenza pandemic preparedness.