Following the registration of the company’s cell-based influenza vaccine, FLUCELVAX® TETRA, in Europe last year, R&D is currently supporting regulatory submissions for the vaccine in other markets, including Brazil and Australia. Clinical studies are continuing in parallel to expand the age indication for FLUCELVAX® down to 6 months. For the Seqirus MF59®-adjuvanted influenza vaccine, FLUAD®, our current focus is on the development of a quadrivalent formulation. We have made a regulatory submission for this vaccine in the US, as well as in other markets, for its licensure in older adults aged 65 years and above. To support the differentiation of FLUCELVAX® and FLUAD® influenza vaccines compared to standard products, Seqirus has established a Centre for Observational Research and Evaluation (CORE) to undertake annual influenza vaccine effectiveness studies as a complement to real-world data generated by public health agencies.
The combination of our cell-based technology and MF59® adjuvant offers significant potential for seasonal protection and pandemic response. In a major milestone for influenza vaccine development, the company has made a regulatory submission to the FDA for the licensure of an MF59®-adjuvanted cell-based H5N1 vaccine - the first ever pandemic vaccine of its kind. The combination of these two technologies offer the potential added benefits of faster manufacture and antigen sparing, meaning the production of more doses more quickly during a pandemic emergency.
Seqirus is also committed to continued process innovation to support yield improvements and to the development of better influenza vaccine assays. We are also active in longer term transformational projects such as a universal influenza vaccine collaboration and programmes investigating and other novel approaches to influenza protection.