The U.S Food and Drug Administration licensed Audenz, an influenza vaccine designed to protect against the H5N1 avian influenza virus.
AUDENZ was developed by Seqirus with support from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The vaccine will be produced at a facility in Holly Springs, N.C.
Most influenza vaccines are manufactured using embryonated chicken eggs, which makes the production of pandemic influenza vaccines vulnerable to disruptions in the egg supply and variations. AUDENZ uses an antigen-sparing adjuvant and cell-based vaccine technology, which boosts the body’s immune response and makes the vaccine more effective.
The amount of vaccine that can be manufactured is limited by the amount of antigen – the part of a vaccine that arms the immune system – that can be produced. However, the adjuvant used in Audenz reduces the amount of antigen needed for the vaccine. By using this antigen-sparing technology, more doses of the vaccine can be made from the same amount of antigen.
In a pandemic, the facility in North Carolina would ramp up and begin supporting AUDENZ. It is the same facility where Seqiris produces Fluad, a seasonal influenza vaccine. By leveraging the infrastructure in a facility that is used to make a seasonal product, the company can enhance the sustainability of its pandemic preparedness.