Seqirus’ Audenz becomes first FDA-approved cell-based adjuvant influenza A vaccine

pharmafile | February 5, 2020 | News story | Research and Development, Sales and Marketing FDA, influenza, pharma, seqirus 

The FDA has just approved the first adjuvanted, cell-based vaccine for the prevention of influenza A (H5N1) in the US, Seqirus’ Audenz, for use in patients of at least six months old.

According to the drug maker, the monovalent vaccine is a combination of MF59 adjuvant and cell-based antigen manufacturing, and is designed to be stockpiled in the event of a pandemic. The medication works by introducing antibodies which act against virus strains that have mutated, which means that less antigen is needed to trigger an immune response and thus a greater number of vaccine doses can be created.

“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge cell-based manufacturing and adjuvant technologies,” said Dr Russell Basser, 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.”

Dr Rick Bright, Director at Biomedical Advanced Research and Development Authority (BARDA), also commented: “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.”

Matt Fellows

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