CSL Seqirus, a global vaccine maker with a massive manufacturing plant in Holly Springs, has won a federal contract to produce a stockpile of vaccines in case of a pandemic of avian influenza, or bird flu.

Under terms of the $22 million contract, awarded by the Biomedical Advanced Research and Development Authority (BARDA), CSL Seqirus will complete the fill-and-finish process for about 4.8 million doses of pre-pandemic vaccine that is well-matched to H5N1, the currently circulating strain of bird flu virus.

“We have started the manufacturing process and will complete the work throughout the summer,” Jon Kegerise, vice president of manufacturing and Holly Springs site head, told the North Carolina Biotechnology Center. “We are bringing on some additional contract workers to support both our seasonal influenza vaccine production as well as this award from the U.S. government.”

This is the fourth award CSL Seqirus has received from BARDA in response to “sustained highly pathogenic avian influenza activity,” the company said in a news release.

Although the U.S. Centers for Disease Control maintains the risk of bird flu to public health is low, “we are closely monitoring the situation because we are acutely aware of the threat that influenza strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners,” said Marc Lacey, global executive director for pandemic at CSL Seqirus. “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.”

CSL Seqirus’ manufacturing facility in Holly Springs, built through a long-term partnership with BARDA, is the largest cell-based influenza vaccine producer in the world and is the first such facility in the United States. Following a $156 million expansion in 2022 that added a second fill-finish line and warehouse space, the facility encompasses almost half a million square feet of space – larger than eight football fields – and supports about 1,000 jobs.

The plant uses 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. A second wave of manufacturing could be enabled to provide further pandemic vaccine as needed.

In addition, 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, according to the company.CSL Sequirus

“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.”

For more than a year, outbreaks of bird flu among wild and farmed birds have been reported in the United States and other parts of North America. In March the virus was reported spreading among U.S. livestock, and since then two human cases of avian influenza associated with exposure to infected dairy cattle were identified in Texas and Michigan.

Human-to-human transmission of the respiratory illness is rare. Illness in people can vary in severity, from no symptoms or mild illness to severe disease and death.

CSL Seqirus’ Holly Springs plant, located on 185 acres about 24 miles south of Research Triangle Park, was built by Novartis in partnership with BARDA and began production in 2014. Novartis sold the plant and its vaccines business in 2015 to CSL Ltd., an Australian biotechnology company, for $275 million.

CSL Seqirus is one of three healthcare businesses owned by the parent company. The other two are CSL Behring, focused on biotherapies and rare diseases, and CSL Vifor, focused on iron deficiency and nephrology.

CSL Ltd. has over 32,000 employees working in more than 40 countries. In 2023 the company reported a net profit after tax of $2.61 billion on sales of $13.3 billion.