CSL Seqirus, the influenza vaccines business of CSL, a Melbourne, Australia-based bio/pharmaceutical company, was selected by the US government to complete the fill–finish process for 4.8 million doses of a pre-pandemic vaccine for avian influenza (i.e., bird flu). The doses will be used to support the US National Pre-Pandemic Influenza Vaccine Stockpile program. 

CSL Seqirus’ agreement with the US government is through the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services as part of the National Pre-Pandemic Influenza Vaccine Stockpile program. The doses will will increase BARDA’s stockpile of vaccine to support the US government’s pre-pandemic response. 

Under the agreement, CSL Seqirus will deliver approximately 4.8 million doses of pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain of the avian (bird) flu. This is the fourth award CSL Seqirus has received from BARDA in response to sustained highly pathogenic avian influenza (HPAI) activity. 

CSL Seqirus’ manufacturing facility in Holly Springs, North Carolina and built through a public-private partnership established in 2009 with BARDA, is a cell-based influenza vaccine-manufacturing facility. Overall, 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. After this, a second wave of manufacturing could be enabled to provide further pandemic vaccine as needed. 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. 

The US Centers for Disease Prevention and Control (CDC) considers the risk to public health from the avian flu to be low, “This agreement, building upon prior agreements with BARDA, will help support the US government’s ability to respond swiftly in the event that the current avian flu situation changes,” said Marc Lacey, CSL Seqirus’ Global Executive Director for Pandemic, in a May 30, 2024, statement. 

Throughout 2023 and 2024, outbreaks of highly pathogenic avian influenza (HPAI) viruses among birds were reported in several regions, including Africa, Asia, Europe, and North America. A multistate outbreak of HPAI A (H5N1) bird flu in dairy cows in the US was first reported on March 25, 2024, marking the first time that these bird flu viruses had been found in cows, according to information from the CDC. On April 1, 2024, CDC confirmed one human HPAI A(H5N1) infection in a person with exposure to dairy cows in Texas that were presumed to be infected with the virus. This is thought to be the first instance of likely mammal-to-human spread of HPAI A(H5N1) virus. In May 2024, CDC began reporting additional, sporadic human cases in people who had exposure to infected dairy cows. These outbreaks have heightened concerns that HPAI could potentially escalate into a pandemic. However, the CDC currently assesses the public health risk as low. As of press time, CDC issued its latest technical report on the virus on June 5, 2024.  

Source: CSL Seqirus, CSL