CSL Seqirus has announced it will complete the fill-and-finish process for the pre-pandemic vaccine to support the US government’s outbreak and preparedness response.
Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and livestock have been reported in the US.
CSL Seqirus was selected by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the US Department of Health and Human Services (HHS), to complete the fill-and-finish process of pre-pandemic vaccine as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program.
“The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners,” said Marc Lacey, CSL Seqirus' global executive director for pandemic. “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.”
Under the terms of the agreement, CSL Seqirus will deliver approximately 4.8 million doses of a pre-pandemic vaccine well-matched to the H5 of the currently circulating H5N1 strain.
This is the fourth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza (HPAI) activity.
“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, the 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.”
CSL Seqirus’ manufacturing facility in Holly Springs, NC, built through a public-private partnership established in 2009 with BARDA, is the world's largest cell-based influenza vaccine producer. It 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.