RESEARCH TRIANGLE PARK – Although most of us currently are consumed by the COVID-19 coronavirus, it’s also the season to be thinking about the flu.

Seqirus, one of the largest influenza vaccine companies in the world, has just announced the release of new data that demonstrate the effectiveness and safety of its pandemic influenza A (H5N1) vaccine. The company has a massive manufacturing facility in Holly Springs.

The vaccine is produced through a novel cell culture process instead of the traditional method of using chicken eggs. It contains an MF59 adjuvant that strengthens, broadens and lengthens the immune response. In other words, the adjuvant helps the vaccine work better, particularly in older patients.

Seqirus flu vaccine plant in Holly Springs

Using MF59 also can reduce the amount of antigen needed to induce an immune response, which means more doses can be produced. And the cell culture process provides for faster scale-up of vaccine manufacturing.

Seqirus said the vaccine is the first-ever adjuvanted, cell-based pandemic influenza vaccine in the United States.

The company presented its data at a virtual conference of the European Scientific Working Group on Influenza (ESWI). It showed that two different doses of the vaccine produced a strong immune response in pediatric, adult and older adult patients. Seqirus said the vaccine was well tolerated by all age groups.

The H5N1 influenza virus that the vaccine is designed to treat has a high pandemic potential because it can be transmitted from birds to humans. And it’s particularly dangerous. The World Health Organization puts the mortality rate at about 60% when humans become infected with influenza A (H5N1).

“By combining our cutting-edge cell-based and adjuvant technologies, we are proud to help provide protection in the event of an influenza pandemic emergency,” said Marc Lacey, executive director, Pandemic Response Solutions at Seqirus. “In the event of an influenza pandemic, it will be critical to have vaccines that have a positive safety profile, are effective and are able to be rapidly produced to protect against a pandemic influenza virus.”

The vaccine’s cell-based components and formulated prefilled syringes are all produced at the Holly Springs site, 24 miles south of Research Triangle Park. The $1 billion-plus plant, located on 185 acres, was built by Novartis in 2014 – in partnership with the U.S. Biomedical Advanced Research and Development Authority – to help combat pandemic threats.  The North Carolina Biotechnology Center was actively involved in recruiting the facility to Holly Springs.

Seqirus was founded in 2015 and took over the facility after its Australian parent, CSL Limited, acquired the influenza business of global pharma company Novartis. It has continued to invest in the site. Seqirus has other production facilities in the U.S., the U.K., and Australia.