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.

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