On January 31, 2020, we achieved a major milestone in pandemic influenza preparedness:  the U.S Food and Drug Administration’s licensure of AUDENZ^TM, the first adjuvanted, cell-based influenza vaccine designed to protect our nation from the H5N1 avian influenza virus.  AUDENZ^TM, which 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, 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.

Modernizing influenza vaccines and domestic manufacturing capacity is a priority for the Trump administration and critical for national health security.   On September 19, 2019, the President issued an executive order that set a clear direction for the next generation of pandemic influenza vaccines: the nation needs more modern, domestically manufactured vaccines that can be produced without relying solely on egg-based processes. AUDENZ^TM 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.

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^TM 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^TM reduces the amount of antigen needed for the vaccine. By using this antigen-sparing technology, more doses of AUDENZ^TM 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^TM. By leveraging the existing domestic manufacturing infrastructure in a facility that is used to make a seasonal product, we are able to enhance the sustainability of our pandemic preparedness.

Vaccines are only one part of BARDA’s pandemic preparedness portfolio. Since the development of the National Pandemic Influenza Strategy in 2005, BARDA has taken a multi-faceted approach to preparing for the next influenza pandemic by collaborating with partners in government and industry to develop innovative therapeutics, vaccines, diagnostics, and devices; establish vaccine stockpiles; and begin to revitalize domestic vaccine manufacturing capacity.

Through these partnerships, BARDA has supported the regulatory approval of a diverse portfolio of medical countermeasures to prevent, detect and treat influenza. Today, we added AUDENZ^TM to that portfolio.

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.