Seqirus to commercialise quadrivalent influenza vaccine

Seqirus has announced plans to commercialise its novel cell-based quadrivalent influenza vaccine (QIVc) across Europe. The company expects QIVc to be the first four-strain, cell-based seasonal influenza vaccine licensed in Europe, expanding the options available to help tackle the significant number of influenza-related deaths and hospitalisations in the region.

QIVc was licensed in the U.S. by the FDA in 2016 and is manufactured in cell lines, not eggs. Recent laboratory studies have shown that some influenza viruses undergo changes when they are grown in eggs, possibly impacting the effectiveness of traditional egg-based influenza vaccines. These same changes are not observed in influenza viruses cultured in cells, leading to the hypothesis that cell-based influenza vaccines may offer better protection against influenza in some seasons.

Seqirus produces QIVc at its state-of-the-art facility in North Carolina, U.S., which was originally built in partnership with the U.S. Government to help combat pandemic threats. Seqirus has rapidly accelerated the development of its cell-based technology, quadrupling seasonal influenza vaccine output in just two years. This swift scale-up and ongoing innovation will enable the company to further increase supply of QIVc in the U.S., and to now also make it available in Europe.

Seqirus has submitted a Marketing Authorisation Application (MAA) for QIVc to the EMA and is preparing for launch in European countries in the 2019-20 influenza season. The company is seeking an initial age indication of four years and above for QIVc and has begun additional clinical studies to ultimately achieve an age indication of six months and above.


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