CSL Seqirus was selected by the Biomedical Advanced Research and Development Authority (BARDA) to deliver a 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.
BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
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. and other parts of North America, spreading into South America during 2023. Widespread avian influenza has also been persistent across Africa, Asia and Europe and mammalian spill-over infections have been reported widely too.
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, a case in Ecuador in January 20235 and Chile in March 2023.
“While human cases are rare, sporadic and isolated, consistent detection of bird and mammalian cases demands vigilance. Ongoing surveillance and preparedness efforts are critical to minimize the public health risk.”Marc Lacey, Executive Director, Pandemic Response Solutions, CSL Seqirus
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 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.
About Pandemic Influenza
Influenza is a contagious airborne respiratory disease. The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the novel virus in the human population. Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide.
Strain-specific pandemic influenza vaccines are manufactured in response to the declaration of a pandemic. Pre-pandemic (also called zoonotic) influenza vaccines are developed in the inter-pandemic period to help protect against influenza strains with pandemic potential; these vaccines can be deployed under government instruction to mitigate the risk of an outbreak or provide a first line of defense in advance of a pandemic vaccine if a pandemic were to be declared.
About Avian Influenza
Avian influenza is an infectious type of influenza that spreads predominantly among birds. In rare cases humans have been infected with avian influenza viruses, with symptoms varying in levels of severity, from asymptomatic or mild illness to severe disease and death. The spread of avian influenza from one human to another is very rare and typically has only spread to a few people.
The recent rise in avian influenza among birds has been driven by highly pathogenic avian influenza (HPAI) A(H5N1).