Seqirus has announced European approval of its new cell-based quadrivalent influenza vaccine.
The European Commission has approved Flucelvax Tetra, which will be the first cell-based quadrivalent influenza vaccine (QIVc) available in Europe, licensed for use in people nine years and above.
Cell-based technology represents one of the most significant changes in the way influenza vaccines are manufactured since the 1940s, and real-world data indicates cell-based flu vaccines may be more effective than standard options in seasons affected by egg-adaptation - in which viruses undergo changes when they are grown in eggs, which may reduce the effectiveness of the resulting vaccines in certain seasons.
There have been no randomised controlled trials comparing the efficacy of QIVc and standard egg-based quadrivalent vaccines (QIVe), just real-world data, and the EMA has already approved Fluxelvax Tetra on the basis of immunogenicity and safety of the QIVc compared to a cell-based trivalent influenza vaccine.
Researchers analysed electronic medical records from 92,192 subjects who received a QIVc and 1,255,983 subjects who received a QIVe to determine which vaccine was more effective in preventing influenza-like illness (ILI), consisting of patients ages four years and above who received either QIVe or QIVc in primary care.
“This real-world study, along with other emerging evidence, indicates that cell-based influenza vaccines may result in better influenza-related outcomes compared to standard egg-based vaccine options in some seasons, particularly those seasons characterised by egg-adapted changes,” said Russell Basser MD, SVP of Research and Development, Seqirus.
“We are greatly encouraged by the data and look forward to working with academic partners to generate additional data in future seasons.”
Flucelvax Tetra is now available to order in the UK for the 2019/20 season.