On January 31, 2020 the FDA approved “the first adjuvanted, cell-based influenza vaccine” called of Audenz, designed to protect individuals 6 months and older against the H5N1 avian influenza virus, and is said to be “a major milestone in pandemic influenza preparedness”. [1]
AUDENZTM, an Influenza A (H5N1) Monovalent Vaccine containing the MF59C.1 adjuvant and hidden ingredients, is sponsored by Seqirus Inc and supported by the US government agency, BARDA. Instead of producing the vaccine in chicken embryos, which is said to have “supply” issues in times of a pandemic, “Audenz uses two leading-edge technologies – an antigen-sparing adjuvant and cell-based vaccine technology – that represent a game-changing advance in the state of pandemic influenza preparedness.”
The application was submitted in January 2019, before President Trump’s Influenza EO, on the grounds “for Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses”. The vaccine will be produced in the US and supplied on demand. The approval letter acknowledged the manufactures “plans to collect additional safety and effectiveness data in the U.S., when Influenza A (H5N1) Monovalent Vaccine, Adjuvanted is used.”
Australia’s CSL (Seqiris part of CSL) has this H5N1 vaccine in “registration” with TGA according to their pipeline.