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 award from BARDA is the fifth avian influenza pandemic preparedness award for CSL Seqirus.
SUMMIT, N.J., Sept. 25, 2024 /PRNewswire/ -- 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 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.
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