Seqirus, a global leader in influenza prevention and a business of CSL Limited announced that 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), has selected Seqirus to develop two influenza A(H2Nx) virus vaccine candidates for assessment in a Phase 1 clinical study with the goal of helping to safeguard communities in the event of an influenza pandemic. Under terms of the multi-year, $34.95 million agreement, Seqirus will provide clinical development services to evaluate the safety, immunogenicity and dose-sparing capability of two influenza A(H2Nx) vaccine candidates: The first candidate will utilize a combination of cell-based and adjuvanted technologies, building on Seqirus' highly flexible combination platform technology used by AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), the first-ever adjuvanted, cell-based influenza vaccine, which was approved by the U.S. Food and Drug Administration in 2020 for use in a pandemic. The second candidate will utilize Seqirus' next-generation self-amplifying mRNA (sa-mRNA) platform, which has demonstrated promise as compared to more traditional influenza vaccine technologies in preclinical research. Seqirus' global product portfolio includes four licensed adjuvanted pandemic and pre-pandemic influenza vaccines, three of which use its proprietary MF59® adjuvant intended to enhance an individual's immune response and potentially be antigen-sparing in the event of a pandemic outbreak. Combining Seqirus' adjuvant technology with its cell-based manufacturing platform may improve protection even further by potentially providing a better match to the circulating virus strain – setting the stage to meet the public health challenge of an influenza pandemic. Additionally, Seqirus' sa-mRNA platform, the next-generation version of today's mRNA technology, builds on traditional mRNA technology by also instructing the body to replicate mRNA, amplifying the amount of protein made. This could enable Seqirus to potentially develop more effective vaccines with a smaller dosage and with lower rates of reactogenicity, underscoring the application in both pandemic and seasonal settings.3 In preclinical research, sa-mRNA technology demonstrated the potential to raise stronger cellular responses and generate significantly higher antibody titers at the same dose level as mRNA. Both cell-based and sa-mRNA technology are steps forward in achieving key objectives found in the U.S. National Influenza Vaccine Modernization Strategy, which focuses on strengthening and diversifying influenza vaccine development, manufacturing and supply chain, and promoting innovative approaches and use of new technologies to detect, prevent and respond to influenza. Seqirus has a longstanding partnership with BARDA. The company's cell-based manufacturing facility in Holly Springs, N.C., the first such domestic facility, was built through a public-private partnership established in 2009 with BARDA. It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response.