Seqirus 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.”
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.