The U.S. Food and Drug Administration (FDA) has approved a new vaccine designed to protect against pandemic influenza A (H5N1).
Developed by Seqirus, Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against H5N1 in the event of a pandemic. It was approved for children aged 6 months or older.
The World Health Organization states that an influenza pandemic occurs when "a new influenza virus emerges and spreads around the world, and most people do not have immunity."
Seqirus notes in a news release that Audenz is designed to be deployed rapidly and can be stockpiled for first responders in the event of pandemic.
The vaccine combines two technologies: MF59 adjuvant and cell-based antigen manufacturing.
The MF59® adjuvant and formulated prefilled syringes used in the Audenz vaccine are produced in a Seqirus production facility built and supported through a public-private partnership between the company and the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
In the Seqirus release, BARDA Director Dr. Rick Bright states, "Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives. With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza – we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic."