Therapy Areas: Respiratory
Seqirus passes US FDA approval of first-ever adjuvanted, cell-based pandemic influenza A (H5N1) vaccine
4 February 2020 -

Vaccine company Seqirus reported on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for AUDENZ to help protect individuals six months of age and older against Pandemic influenza A (H5N1) epidemic, a contagious airborne respiratory disease.

The company said AUDENZ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.

Additionally, the novel vaccine AUDENZ combines two leading-edge technologies MF59 adjuvant and cell-based antigen manufacturing, revealed the company.

In December 2015, the US Food and Drug Administration has awarded Fast Track designation for the aH5N1c vaccine for prevention of illness related to pandemic influenza caused by A (H5N1) virus.

According to the company, AUDENZ is designed to be rapidly deployed to help protect the US population and can be stockpiled for first responders in the event of pandemic.

The cell-based vaccine antigen, MF59 adjuvant and formulated prefilled syringes used in the AUDENZ vaccine are all produced in the state-of-the-art Seqirus production facility in Holly Springs, N.C.,which was built and supported through a multi-year public-private partnership with Biomedical Advanced Research and Development Authority (BARDA).