CSL Seqirus, a Global Leader in Pandemic Preparedness, Announces Fifth BARDA Award in Response to Avian Influenza Outbreak
CSL Seqirus, a business of CSL (ASX: CSL), has received a $121.4 million multi-year award from the Biomedical Advanced Research and Development Authority (BARDA) to expand its Vendor Managed Inventory (VMI) program for MF59® adjuvant. This marks the fifth avian influenza pandemic preparedness award for CSL Seqirus. The expanded program will increase the inventory to 40 million equivalent doses, enhancing the U.S. government's pandemic preparedness efforts.
MF59® adjuvant, manufactured at CSL Seqirus' Holly Springs, North Carolina facility, is important for pandemic preparedness as it reduces the antigen required to produce an immune response, thereby increasing vaccine doses. This expansion comes in response to sustained highly pathogenic avian influenza (HPAI) activity, which the CDC reports is widespread in wild birds and causing outbreaks in poultry and U.S. dairy cows.
CSL Seqirus, un'azienda di CSL (ASX: CSL), ha ricevuto un premio pluriennale da 121,4 milioni di dollari dalla Biomedical Advanced Research and Development Authority (BARDA) per espandere il proprio programma di Vendita Gestita da Fornitori (VMI) per l'adjuvante MF59®. Questo segna il quinto premio per la preparazione alla pandemia di influenza aviare per CSL Seqirus. Il programma espanso aumenterà l'inventario a 40 milioni di dosi equivalenti, migliorando gli sforzi di preparazione alla pandemia del governo degli Stati Uniti.
L'adjuvante MF59®, prodotto presso lo stabilimento di CSL Seqirus a Holly Springs, Carolina del Nord, è importante per la preparazione alla pandemia in quanto riduce l'antigene necessario per produrre una risposta immunitaria, aumentando così le dosi di vaccino. Questa espansione è una risposta all'attività sostenuta di influenza aviare altamente patogena (HPAI), che i CDC riportano essere diffusa tra gli uccelli selvatici e causante focolai tra il pollame e le mucche da latte negli Stati Uniti.
CSL Seqirus, una empresa de CSL (ASX: CSL), ha recibido un premio multianual de 121,4 millones de dólares de la Autoridad de Investigación y Desarrollo Avanzado Biomédico (BARDA) para expandir su programa de Inventario Gestionado por Proveedores (VMI) para el adyuvante MF59®. Este es el quinto premio para la preparación contra la pandemia de influenza aviar para CSL Seqirus. El programa expandido aumentará el inventario a 40 millones de dosis equivalentes, mejorando los esfuerzos de preparación para pandemias del gobierno de los Estados Unidos.
El adyuvante MF59®, fabricado en la planta de CSL Seqirus en Holly Springs, Carolina del Norte, es importante para la preparación ante pandemias, ya que reduce el antígeno necesario para producir una respuesta inmunitaria, aumentando así las dosis de vacunas. Esta expansión es una respuesta a la actividad sostenida de la influenza aviar altamente patógena (HPAI), que los CDC informan está generalizada en aves silvestres y causando brotes en aves de corral y vacas lecheras en los EE. UU.
CSL Seqirus는 CSL(ASX: CSL)의 사업으로, 1억 2,140만 달러의 다년 계약을 생물의학 고급 연구 및 개발 권한(BARDA)으로부터 받아 MF59® 보조제에 대한 공급자 관리 재고(VMI) 프로그램을 확장합니다. 이는 CSL Seqirus에 대한 다섯 번째 조류 인플루엔자 팬데믹 대비 보조금입니다. 확대된 프로그램은 재고를 4천만 개 동등 용량으로 늘려 미국 정부의 팬데믹 대비 노력을 강화할 것입니다.
MF59® 보조제는 CSL Seqirus의 노스캐롤라이나 홀리 스프링스 시설에서 제조되며, 면역 반응을 생성하는 데 필요한 항원을 줄여 백신 용량을 늘이기 때문에 팬데믹 대비에 중요합니다. 이 확장은 CDC가 보고하는 바와 같이, 야생 조류에서 광범위하게 발생하고 가금류 및 미국 유제품의 발병을 초래하는 고병원성 조류 인플루엔자(HPAI) 활동에 대한 대응으로 이루어집니다.
CSL Seqirus, une entreprise de CSL (ASX: CSL), a reçu un contrat pluriannuel de 121,4 millions de dollars de la Biomedical Advanced Research and Development Authority (BARDA) pour étendre son programme d'Inventaire Gérér par les Fournisseurs (VMI) pour l'adjuvant MF59®. Cela marque la cinquième subvention pour la préparation à la pandémie de grippe aviaire pour CSL Seqirus. Le programme élargi augmentera l'inventaire à 40 millions de doses équivalentes, renforçant ainsi les efforts de préparation à la pandémie du gouvernement des États-Unis.
L'adjuvant MF59®, fabriqué dans l'établissement de CSL Seqirus à Holly Springs, Caroline du Nord, est essentiel pour la préparation à la pandémie car il réduit l'antigène nécessaire pour produire une réponse immunitaire, augmentant ainsi les doses de vaccin. Cette expansion intervient en réponse à l'activité soutenue de la grippe aviaire hautement pathogène (HPAI), qui, selon les CDC, est répandue chez les oiseaux sauvages et cause des épidémies chez les volailles et les vaches laitières aux États-Unis.
CSL Seqirus, ein Unternehmen von CSL (ASX: CSL), hat einen Multijahresvertrag über 121,4 Millionen Dollar von der Biomedical Advanced Research and Development Authority (BARDA) erhalten, um sein Vendor Managed Inventory (VMI) Programm für den MF59® Adjuvans auszubauen. Dies ist die fünfte Auszeichnung zur Pandemievorbereitung gegen Vogelgrippe für CSL Seqirus. Das erweiterte Programm wird den Bestand auf 40 Millionen äquivalente Dosen erhöhen und die Pandemievorbereitungsmaßnahmen der US-Regierung verstärken.
Der MF59® Adjuvans, der in der Anlage von CSL Seqirus in Holly Springs, North Carolina, hergestellt wird, ist wichtig für die Pandemievorbereitung, da er die für die Herstellung einer Immunantwort erforderliche Antigenmenge reduziert, wodurch die Impfstoffdosen erhöht werden. Diese Erweiterung erfolgt als Reaktion auf die anhaltende Aktivität von hochpathogener Vogelgrippe (HPAI), die laut den CDC weit verbreitet bei Wildvögeln vorkommt und Ausbrüche bei Geflügel und Milchkühen in den USA verursacht.
- Secured a $121.4 million multi-year award from BARDA
- Expanding MF59® adjuvant inventory to 40 million equivalent doses
- Fifth avian influenza pandemic preparedness award received
- Strengthening public-private partnership with U.S. government
- None.
- Biomedical Advanced Research and Development Authority (BARDA) and CSL Seqirus will expand their reserves of MF59® adjuvant to the equivalent of 40 million doses as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS).
- The multi-year
$121.4 million
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
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
"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
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
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
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
View original content:https://www.prnewswire.com/news-releases/csl-seqirus-a-global-leader-in-pandemic-preparedness-announces-fifth-barda-award-in-response-to-avian-influenza-outbreak-302259141.html
SOURCE CSL Seqirus
FAQ
What is the value of the BARDA award received by CSL Seqirus (CSLLY) for avian influenza preparedness?
How many equivalent doses of MF59® adjuvant will CSL Seqirus (CSLLY) provide under the new BARDA award?
Where does CSL Seqirus (CSLLY) manufacture the MF59® adjuvant for the BARDA contract?
How many avian influenza pandemic preparedness awards has CSL Seqirus (CSLLY) received from BARDA?
