On Friday, the U.S. Food and Drug Administration (FDA) approved Audenz, a vaccine to prevent a potential flu pandemic that is associated with the H5N1 (influenza A) virus.
Developed by Seqirus, Audenz is the first-ever adjuvanted, cell-based flu vaccine that protects against H5N1 in the event of a pandemic.
“The vaccine is designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic,” said Russel Basser, chief researcher and head of research and development at Seqirus.
Speaking from Seqirus’ North Carolina-based manufacturing facility, Basser told BioSpace, “Audenz is a key advance for the company and the nation in preparation for an influenza pandemic.”
If a flu virus becomes pandemic, it would potentially kill millions of people across the world, causing social and economic wreckage. The World Health Organization says a severe influenza pandemic would cause a big loss of national economic productivity, causing severe economic burdens on people and communities.
Basser said, “If there was a pandemic, it would be catastrophic,” noting that the Spanish flu outbreak in 1918 caused by the H1N1 flu virus affected more than 500 million people around the world, killing 50 to 100 million people.
The H1N1 virus is different from the H5N1 virus and the Audenz vaccine targets it. Often called bird flu, the H5N1 virus has been known to be contagious.
Seqirus has been developing the vaccine in association with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS).
Basser said the company will stockpile Audenz doses in case of a pandemic outbreak.
Director of BARDA Rick Bright said the approval of Audenz would help the nation “achieve the security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine.”
Seqirus, which was established in 2015, is now one of the largest providers of flu vaccines in the world. It maintains production facilities in the United States, the United Kingdome, and Australia.
