FDA approves Audenz for influenza A (H5N1).- Seqirus

Seqirus announced that the FDA has approved Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1). Audenz is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.Comment: This is the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain. Seqirus has combined two leading-edge technologies—MF59 adjuvant and cell-based antigen manufacturing—to create this pandemic influenza vaccine. 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.