Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. Food and Drug Administration (FDA) has approved AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) to help protect individuals six months of age and older against influenza A (H5N1). AUDENZ is the first-ever adjuvanted, cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.
The vaccine was developed 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, and will be produced at a facility in Holly Springs, North Carolina to help ensure the vaccine will be available to the American people when they need it most.
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.
As the recent outbreak of a novel coronavirus reminds us, people travel around the world every day and the viruses they may carry do not respect borders. Just over a decade ago, the H1N1 pandemic spread throughout the globe in just a few weeks. During the 2009 pandemic, pregnant women, young children, and other vulnerable populations suffered particularly high rates of infection. A decade before that, the threat of an H5N1 influenza pandemic emerged, with periodic transmission of H5N1 from birds to people, and the threat remains real. Now, we have a licensed cell-based and adjuvanted vaccine that can be manufactured in the U.S. to protect children over 6 months of age, older adults, and other medically vulnerable people. We are better prepared to protect people during an H5N1 pandemic. Rick A. Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
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 in the ways different strains of the virus grow in an egg. Like many agricultural products, egg production is seasonal and the supply of eggs wanes just as the demand for a pandemic influenza vaccine could increase. Although BARDA worked with egg producers to overcome this challenge, responding to a pandemic requires large-scale continuous manufacturing, and egg-based processes have limitations. We would need to use an array of vaccine technologies to produce enough vaccine domestically as quickly as possible.
AUDENZ uses cell-based vaccine technology and an adjuvant, which boosts the body’s immune response and makes the vaccine more effective overall. In the early days of a pandemic, 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 AUDENZ can be made from the same amount of antigen while maintaining the safety and effectiveness of the vaccine. Ultimately, that means more vaccine is available in a given time period.
AUDENZ will use the same adjuvant production facility as FLUAD®, a seasonal influenza vaccine produced by Seqirus in North Carolina. In a pandemic, that facility would ramp up and begin supporting AUDENZ. By leveraging the existing domestic manufacturing infrastructure in a facility that is used to make a seasonal product, Seqirus is uniquely positioned to manufacture cell-based vaccines on a pandemic scale as a result of its public-private partnership with the BARDA.