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 US 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.1,2 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.3
Seqirus produces QIVc at its state-of-the-art facility in North Carolina, USA, which was originally built in partnership with the US Government to help combat pandemic threats.4 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 US, and to now also make it available in Europe.
“Traditional egg-based influenza vaccines have been the mainstay of influenza protection for decades, and remain a very important tool in the defence against the disease,” said Gordon Naylor, President of Seqirus. “As a global leader in influenza, Seqirus is also committed to investing in innovative technologies that have the potential to provide better protection for at-risk groups. “We’ve worked hard to advance our cell-based technology and to quickly scale up production so that we are now capable of supplying this innovative vaccine to healthcare professionals and their patients in Europe,” added Naylor. “Increasing the availability of the vaccine will also enhance our real-world efforts to study the comparative effectiveness between cell and traditional egg-based vaccines from season to season.”
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 4 years and above for QIVc and has begun additional clinical studies to ultimately achieve an age indication of 6 months and above.
“Although adults aged 65 years and over are now being served better with newer flu vaccines, the burden of seasonal influenza in children and other at-risk groups aged under 65 years still continues to be a significant challenge for clinicians and public health experts, particularly where egg adaptation impacts vaccine effectiveness,” said Dr George Kassianos, GP and immunisation expert. We certainly need more flu vaccine options in Europe and I welcome the potential of this new cell-based vaccine.”
QIVc will complement Seqirus’ innovative portfolio in Europe, which includes an adjuvanted influenza vaccine indicated for older adults aged 65 years and above. Seqirus’ adjuvanted influenza vaccine is licensed in key markets in Europe and was recently launched in the UK for the 2018-19 season following a preferential recommendation from UK health authorities.5
References
1 Barr et al. WHO recommendations for the viruses used in the 2013-2014 Northern Hemisphere influenza vaccine: Epidemiology, antigenic and genetic characteristics of influenza A(H1N1) pdm09, A(H3N2) and B influenza viruses collected from October 2012 to January 2013. Available at: http://www.sciencedirect.com/science/article/pii/S0264410X1400187X?via%3Dihub. Last accessed January 2018
2 World Health Organization. Improving influenza vaccine virus selection, Report of the 4th WHO Informal Consultation Hong Kong. Available at http://www.who.int/influenza/resources/publications/Influenza_vaccine_virus_selection_report/en/. Last accessed: January 2018
3 Zost SJ et al. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. PNAS 2017; 114: 12578–12583. Available at http://www.pnas.org/content/pnas/114/47/12578.full.pdf
4 The North Carolina plant has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100200900101C.
5 JCVI minute June 2017 meeting. Available at http://www.nitag-resource.org/uploads/media/default/0001/04/ea8a9b08726f9733f38d83ae87b58d4de2b4f47f.pdf
