The UK government and Valneva were in a €1.4bn ($1.65bn) five-year deal: to not only supply the UK with up to 190 million doses of the French company's COVID-19 vaccine candidate once authorized; but also to boost manufacturing capacity at the company's Livingston site in Scotland. Clinical trials are also under way with government agencies in the UK.
But today Valneva announced today that it has received a termination notice from the UK government for its supply agreement for its COVID-19 vaccine candidate, VLA2001.
Under the contract, the UK government retained the right to cancel. But while it says that Valneva is ‘in breach of its obligations under the supply agreement’, the company denies this. No further details have been given on the nature of the alleged breaches.
The vaccine partnership had included:
- Creation of a 'major UK facility' with government investment in Livingston
- 60 million doses supplied to the UK in 2021 with options for another 130 million doses between 2022 and 2025
- Co-funding of clincial trials
- The deal was set out in September
Brand new vaccine manufacturing facility 'near completion'
Valneva’s vaccine is the only whole virus inactivated adjuvanted candidate against COVID-19 in clinical trials in Europe. It champions a ‘tried and tested’ approach with the vaccine, thanks to the use of tech that has been in use for decades, as well as the vaccine’s ability to be stored and distributed at standard cold chain temperatures (2 to 8°C).
The vaccine commenced rolling submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) just three weeks ago. It appears the company will continue to follow this path: reiterating today that initial approval could be received late this year.
A Phase 3 trial, Cov-Compare, is continuing via government agency, Public Health England, with results expected to be available early in Q4.
However, the company has not commented on what will happen at its Livingston facility in Scotland: which had been ramping up capacity in order to meet the UK order.
Commercial production started in January 2021 in order to meet vaccine supply orders. Three weeks ago a spokesperson told BioPharma-Reporter that the brand new state-of-the-art vaccine manufacturing facility, as part of its partnership with the UK Government, was ‘nearing completion’. A manufacturing recruitment day had been held earlier this month as the company sought to fill 200 new jobs at the site.
In a statement announcing the contract termination this morning, the company said: “Valneva has worked tirelessly, and to its best efforts, on the collaboration with HMG [the UK government] including investing significant resources and effort to respond to HMG’s requests for variant-derived vaccines.
“Valneva continues to be committed to the development of VLA2001 and will increase its efforts with other potential customers to ensure that its inactivated vaccine can be used in the fight against the pandemic.”
Such other supply deals could include one with the EU. Initial talks failed to reach an agreement: but the potential of a deal is now back on the table.
Valneva has not yet started a review process with the European Medicines Agency to authorize a vaccine in the bloc.