FDA Approves Novel Pandemic Influenza Vaccine

Megan Brooks

February 03, 2020

The US Food and Drug Administration (FDA) has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.

Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older.  It's designed to be rapidly deployed to help protect the US population and can be stockpiled for first responders in the event of a pandemic.

The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear 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 US Department of Health and Human Services.

"Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives," BARDA Director Rick Bright, PhD, said in a company news release.

"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," said Bright.

"The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies," Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. "This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency."

Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

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