Seqirus Cell-based Influenza Vaccine Nears European Approval

MAIDENHEAD, England, October 19, 2018 /PRNewswire/ --

Seqirus, a global leader in influenza prevention, today announced that its cell-based quadrivalent influenza vaccine (QIVc) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for use in people aged 9 years and above. Subject to final approval by the European Commission, Seqirus plans to launch the vaccine as FLUCELVAX TETRA^[1] in Europe for the 2019/20 influenza season.

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QIVc was first licensed in the US in 2016 and offers protection against four influenza virus strains -A(H3N2), A(H1N1) and two B virus strains.^[2] The vaccine is produced using innovative cell-based technology, which means it avoids egg-adapted changes associated with traditional manufacturing methods.^[3] QIVc may therefore offer a closer match to circulating viruses than traditional egg-based influenza vaccines, with the potential to provide better protection in some seasons.^[4]

"We are delighted to receive this positive opinion, which takes us one step closer to bringing this truly innovative technology to Europe," said Gordon Naylor, President of Seqirus. "We stand ready to work with health authorities and immunization providers to make the new vaccine available as quickly as possible, helping to reduce the significant number of influenza-related deaths and hospitalizations in the region."

In June this year, the US FDA presented data showing cell-based influenza vaccines to be associated with better hospital outcomes than standard influenza vaccine options during the 2017/18 season.^[5] Seqirus has worked with scientific partners to generate additional real-world data from this same period and will be releasing these data in the coming weeks. Increased availability of cell-based vaccines in future seasons in the US and Europe will provide further opportunities to study their effectiveness.

Seqirus produces QIVc at its state-of-the-art facility in North Carolina, US, which was built in partnership with the US Government to help combat influenza threats.^[6] The company has been able to rapidly scale-up production making it the largest cell-based vaccine producer in the world. It is supplying more than 20 million doses of QIVc in the US this season and has the capacity to meet increased demand as well as expand access to the vaccine to Europe. QIVc will complement Seqirus' portfolio in Europe, which includes an adjuvanted influenza vaccine for adults aged 65 years and above.

The European Commission is due to consider the CHMP recommendation to grant marketing authorization for QIVc by the end of this year.

About Seasonal Influenza

Seasonal influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. The European Centre for Disease Prevention and Control (ECDC) estimates that 15,000 - 70,000 people in Europe die from influenza-related complications each year, and encourages annual vaccination as the most effective way to prevent influenza.

About Seqirus

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.

Seqirus was established on 31 July 2015 following CSL's acquisition of the Novartis influenza vaccines business. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza and a transcontinental partner in pandemic preparedness.

Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.

For more information visit http://www.seqirus.com and http://www.csl.com.

References

1. Data on File. Summit, NJ: Seqirus USA Inc; 2018.
2. FLUCELVAX QUADRIVALENT (Influenza Vaccine) [package insert]. Summit, NJ: Seqirus USA Inc; 2018.
3. Rajaram S., Van Boxmeer J., Leav B., et al. (2018). Retrospective evaluation of mismatch from egg-based isolation of influenza strains compared to cell-based isolation and the possible implications for vaccine effectiveness. Presented at IDWeek 2018, October 2018.
4. Centres for Disease Control (CDC). Cell-Based Flu Vaccines. November 2016. https://www.cdc.gov/flu/protect/vaccine/cell-based.htm Accessed October 2018.
5. Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices (ACIP) Presentation Slides: June 2018 Meeting. https://www.cdc.gov/vaccines/acip/meetings/slides-2018-06.html Accessed October 2018.
6. This project 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 numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I

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