Seqirus Announces U.S. FDA Approval for Multi-Dose Vial Presentation of First-Ever Adjuvanted, Cell-Based Pandemic Influenza Vaccine

Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that the U.S. Food and Drug Administration (FDA) has granted supplemental approval of a multi-dose vial (MDV) presentation of AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.

The FDA approval of the MDV presentation of AUDENZ™, which was originally approved by the FDA in 2020 in a single dose, prefilled syringe (PFS) presentation, marks an important milestone in Seqirus' pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Under the terms of the public-private partnership, established in 2009, Seqirus would position itself to deliver 150 million influenza vaccine doses to the U.S. government to support an influenza pandemic response within six months.

"Producing AUDENZ in multi-dose 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, Executive Director, Pandemic Response Solutions, Seqirus. "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."

Seqirus' Adjuvanted, Cell-Based Technology

AUDENZ™ combines Seqirus' proprietary MF59® adjuvant technology with its cell-based manufacturing platform. Cell-based manufacturing, an alternative to traditional egg-based manufacturing, avoids egg-adapted changes, one source of strain mismatch between the vaccine and circulating influenza virus.

Influenza vaccines using the MF59® adjuvant are designed to enhance and broaden the body's immune response by creating broad, cross-reactive antibodies. This adjuvant is an important part of pandemic preparedness planning as it reduces the amount of antigen required to produce an immune response, increasing the number of doses of vaccine developed, so that a large number of people can be vaccinated as quickly as possible.

Longstanding Partnership Between Seqirus and BARDA

Seqirus' longstanding partnership with BARDA also supported the company's cell-based manufacturing facility in Holly Springs, N.C., the first such domestic facility, that utilizes a highly scalable method of production.

In October 2021, Seqirus announced a new $34.95 million agreement with BARDA to develop two influenza A(H2Nx) virus vaccine candidates: the first using the adjuvanted, cell-based combination platform technology used by AUDENZ™, and the second using Seqirus' next-generation self-amplifying mRNA (sa-mRNA) platform.

About Pandemic Influenza

Pandemic influenza, is a contagious airborne respiratory disease which is unpredictable in timing and severity. The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the virus in the human population. Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide. According to the CDC, a novel influenza A virus such as the highly pathogenic avian A(H5N1) strain can cause severe disease and have a high mortality rate. If the influenza A(H5N1) virus were to change and become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be severe.15

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

About CSL

CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. 

November 24, 2021

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