BRIEF—Accelerated FDA approval for Seqirus' Audenz

The US Food and Drug Administration last Friday granted accelerated approval for the Biologics License Application (BLA) for Audenz, influenza A (H5N1) monovalent vaccine, adjuvanted, submitted by Seqirus, the vaccines business of Australia CSL Limited,  for use in persons six months of age and older.

In a letter to the company’s US subsidiary, the FDA said:

“You are hereby authorized to introduce or deliver for introduction into interstate commerce, Influenza A (H5N1) Monovalent Vaccine, Adjuvanted under your existing Department of Health and Human Services US License No. 2049.

“However, we acknowledge the statement in your submission of January 29, 2020, that Seqirus Inc does not intend to market this product for commercial distribution in the US since it will be produced and distributed under contract to the US government as part of national pandemic preparedness initiatives.

“In addition, we acknowledge that you intend to collaborate with the Food and Drug Administration (FDA) and other governmental agencies in the US on plans to collect additional safety and effectiveness data in the US, when Influenza A (H5N1) Monovalent Vaccine, Adjuvanted is used.