$34.95 Million Contract Awarded to Develop Pandemic Influenza Vaccines

New Jersey-based Seqirus USA announced that the Biomedical Advanced Research and Development Authority (BARDA) selected the Company to develop two influenza A(H2Nx) virus vaccine candidates for assessment in a Phase 1 clinical study.

The goal of these vaccine candidates is to help safeguard communities in the event of an influenza pandemic.

The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal flu because there is likely 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.

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 vaccine 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 (FDA) 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.  

“As a global leader in pandemic influenza preparedness, Seqirus understands the vital role of global partnerships in preparing for the unpredictable, ever-present threat of pandemic influenza, which, according to the World Health Organization, is a matter of ‘when,’ not ‘if,’” stated Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus, in a press release issued on October 4, 2021.

Seqirus’ current 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 builds on traditional mRNA technology by 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 lower reactogenicity rates, underscoring the application in both pandemic and seasonal vaccine settings. 

In preclinical research, sa-mRNA technology demonstrated the potential to raise more robust 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.

BARDA is a division of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

Seqirus is part of CSL Limited (ASX: CSL) 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 worldwide.