NEWS

CSL to access late-stage next-generation mRNA platform technology, enabling development of vaccines for COVID-19, influenza, multi-pathogen pandemic preparedness and other respiratory pathogens

• CSL Seqirus will manufacture and clinically assess a cell-based, adjuvanted pre-pandemic influenza vaccine candidate to support the U.S. government’s pandemic preparedness activities
• Third influenza pandemic preparedness award to CSL Seqirus under a multi-year agreement with Biomedical Advanced Research and Development Authority (BARDA)

Data published in Molecular Therapy – Methods and Clinical Development confirm the potential preclinical benefit of the sa-mRNA technology platform, the next generation of mRNA vaccine technology

• This year marks the first full season that Seqirus’ portfolio of innovative influenza vaccines provides a differentiated vaccine option for people of all ages who are eligible in the U.S. to receive a flu shot
• Seqirus will offer FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine, which is now available for eligible persons six months of age and older
• Seqirus will offer FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), which is now preferentially recommended by the CDC’s Advisory Committee for Immunization Practices as one of the preferred vaccine options for adults 65 years and older, over standard-dose influenza vaccines

• Seqirus is officially recognized by the U.S. government as having successfully established domestic manufacturing capability for innovative cell-based seasonal and pandemic influenza vaccines.
• Holly Springs, N.C., facility is ready to deliver 150 million doses of pandemic influenza vaccine to the U.S. government in the event of an influenza pandemic.

• Renewal reaffirms longstanding, public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA) to strengthen preparedness and rapid response capabilities for influenza pandemics
• Agreement includes provision for Seqirus to provide BARDA with supply of AUDENZ, the first-ever FDA-approved adjuvanted, cell-based pandemic influenza vaccine, which was developed in partnership with BARDA

New facility in Waltham, Massachusetts, will support CSL’s growing R&D portfolio, including the self-amplifying mRNA technology platform, the next generation of mRNA vaccine technology, for seasonal and pandemic influenza vaccines.

• The FDA has granted approval of multi-dose vial presentation for AUDENZ™ to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic.
• As the first-ever adjuvanted, cell-based influenza vaccine, AUDENZ™ was originally approved by the FDA in February 2020 in prefilled syringe presentation.
• This approval marks an important milestone in the company’s pandemic preparedness efforts in partnership with Biomedical Advanced Research and Development Authority (BARDA).

• Approval aligns with universal age recommendation for all eligible people six months and older to receive annual influenza vaccination 1
• Cell-based influenza vaccines are designed to produce an exact match to the World Health Organization (WHO)-selected influenza virus strains 2,3
• This approval reinforces the value of this innovative influenza vaccine technology as part of Seqirus’ mission to help protect as many eligible people as possible against influenza, especially in light of the ongoing COVID-19 pandemic

• Seqirus will develop and evaluate two influenza A(H2Nx) virus vaccine candidates in support of U.S. government pandemic preparedness objectives
• Company will utilize its combination of cell-based and adjuvanted influenza vaccine technologies, as well as its next-generation self-amplifying mRNA platform
• Multi-year contract with Biomedical Advanced Research and Development Authority (BARDA) builds on longstanding, successful public-private partnership to provide rapid vaccine manufacturing response in an influenza pandemic