Influenza vaccine manufacturer Seqirus is to manufacture its cell-based influenza vaccine (FLUCELVAX® TETRA) using cell-based Candidate Vaccine Viruses (CVVs) for all four strains recommended by the World Health Organization (WHO) each season, making the entire production process cell-based.
The company will file data with the European Medicines Agency (EMA) to support this decision as part of the 2019/20 Annual Strain Update requirement.
CVVs are provided each season by the WHO Global Influenza Surveillance and Response System (GISRS) and associated laboratories.
The manufacturing seeds produced from these CVVs are used to grow large quantities of virus, in either eggs or cells, enabling the mass production of influenza vaccine matched to the WHO-recommended strains.
According to a recent study, which evaluated the degree of match of egg-based and cell-based CVVs to the circulating seasonal virus strain over the past 12 seasons, cell-based H3N2 CVVs have been more closely matched to the circulating virus than the egg-based H3N2 CVVs.
In the US, Seqirus incorporated a cell-based H3N2 CVV in FLUCELVAX for the 2017/18 season and cell-based CVVs for both B strains in the 2018/19 season. The inclusion of a cell-based CVV for the remaining A strain in the 2019/20 season formulation will complete the transition to an exclusively cell-based product. Demand has increased in the U.S. and Seqirus is preparing to launch the product in Europe in the upcoming season.
Gordon Naylor, President of Seqirus, said: “Egg-based vaccines are the standard of care and continue to play a critical role in the fight against influenza, but it’s important to continuously evolve approaches to vaccine development.
“Cell-based influenza vaccines represent a significant advancement in influenza protection.”