Seqirus’ cell-based influenza vaccine receives CHMP support

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Seqirus announces that their cell-based influenza vaccine has received a CHMP positive opinon.

Seqirus, a global leader in influenza prevention, has 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® TETRA1 in Europe for the 2019/20 influenza season.

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.

In July of this year Seqirus collaborated with the Human Vaccines Project to advance influenza vaccine research

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. The vaccine is produced using innovative cell-based technology, which means it avoids egg-adapted changes associated with traditional manufacturing methods. 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.

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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. 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 a cell-based influenza vaccine in future seasons in the US and Europe will provide further opportunities to study their effectiveness.

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

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