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11/30/2021

Seqirus receives FDA nod for new Audenz presentation

The FDA approved Seqirus’ multidose vial presentation for Audenz to help protect individuals aged six months old and older against influenza A(H5N1) in the event of a pandemic.
Sandra Levy
Senior Editor
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The Food and Drug Administration has given its blessing to Seqirus for a multidose vial presentation for Audenz.

The product is indicated to help protect individuals aged six months old and older against influenza A(H5N1) in the event of a pandemic.

[Read more: Walgreens rolls out 2021-2022 flu shots]

As the first-ever adjuvanted, cell-based influenza vaccine, Audenz was originally approved by the FDA in February 2020 in prefilled syringe presentation.

This approval marks an important milestone in the company's pandemic preparedness efforts in partnership with the Biomedical Advanced Research and Development Authority.

[Read more: GSK starts shipping influenza vaccines for 2021-2022 season]

Producing Audenz in multidose vials allows for increased speed and efficiency, which is absolutely critical to help protect public health in the case of an influenza pandemic, said Marc Lacey, Seqirus executive director of pandemic response solutions. According to the CDC, the influenza A(H5N1) virus is highly pathogenic and has high pandemic potential, so it's critical to be prepared. Seqirus is committed to partnering with key stakeholders to develop adequate and effective influenza pandemic preparedness plans.

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