Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today 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:1
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.
"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,'" said Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus." Seqirus is uniquely positioned to use our pandemic influenza vaccine expertise, flexible platform technologies and innovative research capabilities to reliably 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.
Seqirus to Utilize Proven and Promising Platform Technologies
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. 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 and BARDA Build on Longstanding, Successful Partnership
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.
"As the largest cell-based influenza vaccine producer in the world, Seqirus' Holly Springs facility makes a significant – and growing – contribution to the supply of seasonal influenza vaccines in the U.S., reflecting our ability to protect public health on an annual basis and underscoring our preparedness to respond to future influenza pandemics," said Dave Sehgal, Executive Director, Manufacturing and Holly Springs Site Head, Seqirus. "We remain 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.
HHS continuously monitors emerging infectious disease risk and prepares to respond to the threat of novel emerging infectious disease outbreaks in the United States.11 The National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) has been established and satisfies requirements for vaccine and adjuvants to address influenza viruses that are assessed to be the highest risk for human infection.
While there is no currently circulating strain of influenza A(H2Nx) virus in humans, H2Nx strains continue to circulate in avian reservoirs and triggered the 1957 pandemic, which caused an estimated 1.1 million deaths worldwide and 116,000 deaths in the United States. Population immunity to H2 viruses is insufficient to block epidemic spread, and currently stockpiled influenza A(H5Nx) and A(H7N9) virus vaccine antigens will provide no protection in the case of any emerging influenza A(H2Nx) virus.
Seqirus holds agreements with 30 governments worldwide to provide a strain-matched vaccine in the event of an influenza pandemic. In partnership with the U.S. government, Seqirus and its legacy companies have developed vaccines against 12 different pre-pandemic strains since 2006, including H5, H7 and H1. This agreement adds H2 to this arsenal.
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