Seqirus gets FDA nod for Audenz

There is a new vaccine available to protect individuals six months of age and older against influenza A in the event of a pandemic. The Food and Drug Administration has given its blessing to Seqirus’ Audenz (Influenza A (H5N1) monovalent vaccine, adjuvanted).

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, Seqirus chief scientist and senior vice president of research and development. "This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency."

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," said Biomedical Advanced Research and Development Authority director Rick Bright. "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."