Under the agreement announced yesterday, Valneva is set to supply the UK with 60 million doses at €470m ($558.8m) in the second half of 2021; with options for another 130 million doses between 2022 and 2025. This would take the total value of the 5-year deal up to €1.4bn ($1.66bn).
The UK government will also invest in Valneva’s Scottish manufacturing facility in Livingston to increase capabilities and hire new staff; as well as co-fund ongoing clinical trials for the vaccine candidate.
The vaccine is expected to enter the clinic by December 2020 and – if successful – hopes to gain regulatory approval in H2 2021.
Production capacity set to quadruple
Valneva’s vaccine candidate, VLA2001, uses the French company’s existing Japanese encephalitis vaccine manufacturing platform (the vaccine, Ixiaro, was approved in 2009 in the US and is also EMA approved).
The inactivated, adjuvanted, two-dose SARS-COV-2 vaccine candidate uses Valneva’s platform with the Dynavax CpG 1018 adjuvant.
Valneva is preparing to increase manufacturing capability in Scotland, with the UK Government also contributing up-front to this work (with its investment being recouped against the vaccine supply under the partnership).
“The Livingston site currently employs more than 100 people, with a quarter working directly with the virus, and the number of researchers working on the vaccine’s manufacture is expected to increase by a further 75 once production starts,” David Lawrence, CFO, Valneva, told BioPharma-Reporter.
“Upping manufacturing capacity will include a combination of expanding the existing facility and building a new one at the Livingston site. Valneva will build a total of five production lines equipped with modern, disposable cell-culture systems of about 500 L.”
Valneva will arrange COVID-19 vaccine production around its existing vaccines.
“We currently have one production line available for COVID-19 in our existing facility where we also manufacture Japanese encephalitis and Chikungunya: we are then adding two other production lines for COVID-19 in a second facility that we just acquired. This new facility will multiply our COVID-19 capacity by four to five times; from around 50 million doses per annum to over 200 million doses per annum.”
In May Pfizer partnered with Valneva to progress its vaccine candidate for Lyme disease. Valneva’s chikungunya vaccine, meanwhile, commenced Phase 3 clinical studies last week.
