Valneva will supply up to 100 million doses of a SARS-CoV-2 vaccine candidate and is looking to expand capacity at facilities in Scotland and Sweden.
Under the terms of the deal, French vaccine firm Valneva SE will manufacture up to 100 million doses of its candidate VLA2001 as part of a UK government strategy to secure COVID-19 vaccines.
Doses will be supplied from Valneva‚Äôs production site for¬†other¬†commercially available travel vaccines and candidates in Livingston, Scotland.
‚ÄúToday‚Äôs agreement from the UK government to provide up to 100 million doses of its SARS-CoV-2 vaccine candidate is something that is feasible at the Livingston facility and we have potential to ramp up production, if needed,‚ÄĚ the company told us.¬†‚ÄúWe plan to deliver 60 million doses to UK in H2 2021 and to install approximately 200 million dose capacity thereafter.‚ÄĚ
The firm is also eying up investments in its manufacturing facility in Solna, Sweden as part of its broader COVID-19 response.
The vaccine is expected to enter clinical studies by the end of 2020 and to potentially reach regulatory approval in the second half of 2021.
Financial details have not been divulged, but the announcement came on the same day the UK government secured a deal for 30 million doses of Pfizer and BioNTech‚Äôs mRNA vaccine candidate.
JE platform and manufacture
The candidate uses the same platform as Valneva‚Äôs Japanese encephalitis (JE) vaccine, Ixiaro, approved in Austria, Canada, UK, US, France, and Nordic nations.
The vaccine platform uses an inactivated whole-virus approach where live virus is grown in cell culture and then inactivated (i.e. making it unable to replicate and infect cells) via chemical treatment.
‚ÄúThis platform operates on a highly purified Vero-cell based, inactivated, whole virus¬†technology¬†for vaccine development,‚ÄĚ the company said, before explaining how it is made:
‚ÄúVero cells are a¬†type of cell¬†culture that has been optimized for amplification of viruses. Multiple viral harvests from this cell culture system are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated.
‚ÄúEach fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified antigen content and formulated by addition of aluminum hydroxide before being further purified and packaged for shipment and use globally.‚ÄĚ