Seqirus, a global leader in influenza prevention and pandemic response, announced that the U.S. Food and Drug Administration (FDA) has approved AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1). AUDENZ is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
The novel vaccine combines two leading-edge technologies—MF59® adjuvant and cell-based antigen manufacturing. AUDENZ is designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of pandemic.
“The approval of AUDENZ represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge cell-based manufacturing and adjuvant technologies,” said Russell Basser, MD, Chief Scientist and Senior Vice President of Research and Development at Seqirus. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
The cell-based vaccine antigen, MF59® adjuvant, and formulated prefilled syringes used in the AUDENZ vaccine are all produced in the state-of-the-art Seqirus production facility in Holly Springs, N.C., built and supported through a multi-year public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.