Policy & Regulation
Seqirus receives supplemental US FDA approval for AUDENZ multi-dose vial presentation
24 November 2021 -

Seqirus, a US-based company that deals with influenza prevention and a CSL Limited (ASX:CSL) business, announced on Tuesday that it has received supplemental approval from the United States Food and Drug Administration (FDA) for a multi-dose vial presentation of AUDENZ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), the first-ever adjuvanted, cell-based influenza vaccine aimed at protecting individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.

The approval is claimed to represent an important milestone in the company's pandemic preparedness efforts in collaboration with the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response within the United States Department of Health and Human Services.

According to the terms of the public-private collaboration, the company is to position itself to deliver 150 million influenza vaccine doses to the United States government to support an influenza pandemic response within six months.



Related Headlines