Seqirus announced the renewal of a five-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).
The agreement further strengthens the U.S. government's pandemic preparedness and response capability by ensuring ready production of medical countermeasures (MCMs). This allows BARDA to request that Seqirus provide influenza vaccines and adjuvants for pre-pandemic stockpiling or for manufacture to support rapid response to an influenza pandemic or other public health emergency. Seqirus and BARDA have held similar agreements since 2006.
Seqirus stands ready to provide BARDA with:
· Supply 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 vaccine 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 possible strain mismatch between the vaccine and circulating influenza virus.3,4 AUDENZ™ was approved in 2020 and received a supplemental FDA approval in 2021.
· Supply of its proprietary MF59® adjuvant, which when added to an influenza vaccine, is 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 produced. This ensures that a large number of people can be vaccinated as quickly as possible, as directed by the U.S. National Influenza Vaccine Modernization Strategy and the White House American Pandemic Preparedness Plan.
· Access to pre-pandemic vaccines using either cell- or egg-based manufacturing technologies from Seqirus' global network of production facilities, including Holly Springs, North Carolina; Liverpool, United Kingdom; and Parkville, Australia. In a pandemic, BARDA would source vaccines from the Holly Springs facility.
"As a global leader in seasonal influenza prevention and pandemic influenza preparedness, Seqirus remains committed to working with BARDA and other global partners on the front line of public health in mitigating the potentially devastating effects of another influenza pandemic," said Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus. "With our proven ability to provide a differentiated portfolio of seasonal influenza vaccines across the globe, Seqirus is well-positioned to apply our pandemic influenza vaccine expertise, flexible platform technologies and innovative research capabilities to meet the needs of the U.S. government in such a critical capacity. We are proud to be a trusted partner in support of BARDA's pandemic preparedness objectives."
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