SUMMIT, N.J.—Seqirus, the world’s largest cell-based influenza vaccine manufacturer, has announced its decision to file an Annual Strain Update with the U.S. Food and Drug Administration (FDA) in the coming weeks, including the decision to manufacture its cell-based influenza vaccine (Flucelvax Quadrivalent) for the 2019/20 season using a cell-based candidate vaccine virus (CVV) for all four influenza strains recommended by the World Health Organization (WHO). This decision will make the entire production process exclusively cell-based.
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.
“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,” said Gordon Naylor, president of Seqirus. “While we continue to manufacture and distribute egg-based vaccines globally, cell-based influenza vaccines represent a significant advancement in influenza protection. Seqirus is proud to continue to innovate this promising technology as part of our leading role on the front line of influenza prevention and pandemic preparedness.”
Seqirus produces Flucelvax Quadrivalent at its Holly Springs facility in North Carolina. The facility was purpose-built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to help combat pandemic threats. When production first began in 2014, the site utilized egg-based CVVs in its cell-based manufacturing process. In 2016, the WHO began to recommend cell-based CVVs and the FDA issued an approval for Seqirus to use them in the production of cell-based influenza vaccines.
Seqirus incorporated a cell-based H3N2 CVV in Flucelvax Quadrivalent 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. This achievement complements other innovations that have enabled the site to more than quadruple production in the last three years, as demand has increased in the US. Seqirus is also preparing to launch the product in Europe next season.
“We’ve taken a stepwise approach to the introduction of this latest advancement to our cell-based technology, enabling us to continue to scale up manufacturing at Holly Springs. It will help us to fully realize the potential of our cell-based technology and enhance our ability to deliver on our commitment to public health,” noted Naylor.
The introduction of cell-based CVVs into the global influenza system is the result of a multi-year collaboration involving the WHO Collaborating Centre for Surveillance, Epidemiology and Control of Influenza at the U.S. Centers for Disease Control and Prevention (CDC), the WHO Collaborating Centre for Reference and Research on Influenza in Melbourne, Australia, and scientists at Seqirus and its predecessor company. Seqirus is part of CSL Limited, which is headquartered in Melbourne, and was established in 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL.
“Major advances in influenza prevention require significant global collaboration between industry and public health agencies,” Naylor added. “We thank the many partners involved in advancing promising technologies and remain committed to our shared goal of reducing the number of lives lost to influenza each season.”