Seqirus’s Pandemic Influenza Vaccine Gets FDA Approval

The FDA approved Seqirus’ Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to protect individuals six months or older against influenza A (H5N1).

The novel vaccine combines MF59 adjuvant and cell-based antigen manufacturing. The product is designed to be stockpiled for use by first responders in case of pandemic. 

The approval makes Audenz the first adjuvanted, cell-based influenza vaccine designed to protect against influenza A in the event of a pandemic.