- CSL Seqirus will deliver further H5N8 A/Astrakhan antigen to support the U.S. government's pandemic preparedness activities
- This is the third influenza pandemic preparedness award to CSL Seqirus in the last two years, building on a longstanding partnership with BARDA
SUMMIT, N.J., Aug. 28, 2023 /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 deliver one bulk lot of H5N8 A/Astrakhan antigen to the U.S. government. This acquisition of a bulk lot will increase BARDA's stockpile of vaccine to support rapid response in an associated influenza pandemic.
For more than a year, outbreaks of highly pathogenic avian influenza (HPAI) A(H5) viruses among wild and farmed birds, as well as commercial poultry, have been reported in the U.S.1 and other parts of North America, spreading into South America during 2023.2 Widespread avian influenza has also been persistent across Africa, Asia and Europe3 and mammalian spill-over infections have been reported widely too.4 While the likelihood of sustained human-to-human transmission is "low", according to the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO), there have been reported a small number of human cases of avian influenza A(H5) in the region, including one in the U.S. in April 2022,1 a case in Ecuador in January 20235 and Chile in March 2023.2
"While human cases are rare, sporadic and isolated, consistent detection of bird and mammalian cases demands vigilance," said Marc Lacey, Executive Director, Pandemic Response Solutions, CSL Seqirus. "Ongoing surveillance and preparedness efforts are critical to minimize the public health risk."
Under the terms of the agreement, CSL Seqirus will deliver one bulk lot of H5N8 A/Astrakhan antigen to support the U.S. government's pandemic response readiness. This is the third award CSL Seqirus has received from BARDA related to the ongoing outbreak of HPAI, following the February 2022 award to produce an H5N8 A/Astrakhan virus vaccine seed and subsequent October 2022 announcement of the selection of CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study. CSL Seqirus has been working together with BARDA in a longstanding partnership for more than a decade, which has included numerous R&D and manufacturing activities and awards in support of BARDA's pandemic preparedness objectives.
CSL Seqirus used its cell-based influenza vaccine technology, as utilized for FDA-approved AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), to manufacture the H5N8 A/Astrakhan bulk vaccine at the company's Holly Springs, North Carolina, facility, which was built in partnership with BARDA. In 2022, the Holly Springs facility successfully achieved all of BARDA's criteria required to establish domestic manufacturing capability for innovative cell-based seasonal and pandemic influenza vaccines. CSL Seqirus established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.
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 number 75A50122D00004.
