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Seqirus secures first cell-based quadrivalent influenza vaccine approval in Europe

Published on 14/01/19 at 12:14pm

Seqirus has made it known that its new cell-based seasonal influenza vaccine Flucelvax Tetra has been approved by the European Commission for patients over the age of nine, making it the first cell-based quadrivalent influenza vaccine (QIVc) available in Europe.

The EC’s decision on the vaccine was made “on the basis of immunogenicity and safety” compared to a cell-based trivalent vaccine. So far, there have been no randomised clinical trials directly comparing the effectiveness of QIVc to standard egg-based quadrivalent vaccines (QIVe), but, at the Canadian Immunisation Conference (CIC) in December 2018, Seqirus presented data harvested from 1.3 million medical records which suggested that QIVc was 36.2% more effective at preventing influenza-like illness in patients older than four.

“This real-world study, along with other emerging evidence, indicates that cell-based influenza vaccines may result in better influenza-related outcomes compared to standard egg-based vaccine options in some seasons, particularly those seasons characterised by egg-adapted changes,” remarked Dr Russell Basser, Senior Vice President of Research and Development at Seqirus. “We are greatly encouraged by the data and look forward to working with academic partners to generate additional data in future seasons.”

This data was drawn from just one flu season, 2017-18, but it has been noted that this season was one of the worst in recent years due to the prevalence of the H3N2 virus. Egg-based vaccines have been shown in research to succumb to changes in the virus which can ultimately cause them to offer less protection than cell-based vaccines.

The company noted that such benefits of QIVc were recognised by the Canadian Immunisation Conference (CIC) in December 2018 in its guidance for the 2019-20 influenza season, which asserted that such a vaccine would be suitable for patients aged over 65, and those under that age in at-risk groups.

 “The burden and impact of influenza remains an important global healthcare concern and ensuring we have effective vaccines is a public health imperative,” added Seqirus President Gordon Naylor. “As a company on the front line of influenza protection, we are pleased to make our cell-based technology available in Europe to help reduce deaths and severe illness caused by influenza.”

Matt Fellows

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