The Food & Drug Administration approved a multi-dose vial presentation of Audenz, a vaccine made by Summit-based Seqirus for individuals six months and older against bird flu, also known as influenza A or H5N1.
Audenz was originally approved by the FDA in February 2020 in prefilled syringe presentation, and the approval of a multi-dose vial presentation marks an “important milestone in the company’s pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority,” the company said in a Nov. 23 statement.
BARDA is a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, and under the terms of a public-private partnership established in 2009, Seqirus will position itself to deliver 150 million influenza vaccine doses to the U.S. government to support a flu 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 Seqirus Executive Director of Pandemic Response Solutions Marc Lacey in a statement. “According to the [Centers for the Disease Control & Prevention], the influenza A 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, according to the CDC. The risk of death is higher than seasonal influenza because there is likely to be little or no pre-existing immunity to the virus in the human population, according to the World Health Organization.
