Seqirus Announces FDA Approval Of Multi-dose Vial Presentation For AUDENZ

Seqirus, a business of CSL Limited, announced the FDA has granted supplemental approval of a multi-dose vial presentation of AUDENZ, the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1). Seqirus noted that the FDA approval marks an important milestone in its pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority.

In October 2021, Seqirus announced a new $34.95 million agreement with BARDA to develop two influenza A(H2Nx) virus vaccine candidates: the first using the adjuvanted, cell-based combination platform technology used by AUDENZ, and the second using Seqirus' next-generation self-amplifying mRNA platform.

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