Seqirus Announces U.S. FDA Approval for Multi-Dose Vial Presentation of First-Ever Adjuvanted, Cell-Based Pandemic Influenza Vaccine
November 23, 2021 at 08:30 am EST
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CSL Limited announced that the U.S. Food and Drug Administration (FDA) has granted supplemental approval of a multi-dose vial (MDV) presentation of AUDENZ? (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic. The FDA approval of the MDV presentation of AUDENZ?, which was originally approved by the FDA in 2020 in a single dose, prefilled syringe (PFS) presentation, marks an important milestone in Seqirus' pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Under the terms of the public-private partnership, established in 2009, Seqirus would position itself to deliver 150 million influenza vaccine doses to the U.S. government to support an influenza pandemic response within six months. Seqirus' Adjuvanted, Cell-Based Technology: AUDENZ? combines Seqirus' proprietary MF59? adjuvant technology with its cell-based manufacturing platform. Cell-based manufacturing, an alternative to traditional egg-based manufacturing, avoids egg-adapted changes, one source of strain mismatch between the vaccine and circulating influenza virus. Influenza vaccines using the MF59? adjuvant are designed to enhance and broaden the body's immune response by creating broad, cross-reactive antibodies. This adjuvant is an important part of pandemic preparedness planning as it reduces the amount of antigen required to produce an immune response, increasing the number of doses of vaccine developed, so that a large number of people can be vaccinated as quickly as possible.
CSL Limited is an Australia-based biotechnology company. The Companyâs areas of focus include rare and serious diseases, influenza vaccines and iron deficiency and nephrology. The Companyâs segments include CSL Behring, CSL Seqirus and CSL Vifor. The CSL Behring segment manufactures, markets and distributes plasma products, gene therapies and recombinants. The CSL Seqirus segment manufactures, markets and distributes predominantly influenza related products and provides pandemic services to governments. The CSL Vifor segment manufactures, markets and distributes products in the therapeutic areas of iron deficiency and nephrology. Its CSL Plasma operates plasma collection networks, with more than 325 plasma collection centers in the United States, Europe and China. The Company operates in Australia, the United States, Germany, the United Kingdom, Switzerland and China. Its products include Respreeza, Zemaira, HAEGARDA, KCENTRA, Hepatitis B, Evogam and others.
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