In August the European Commission and Valneva signed an amendment to the Advance Purchase Agreement, with the Commission now purchasing 1.25 million doses in 2022 (a previous agreement in November 2021 had covered up to 24.3 million doses in 2022 with up to 60 million across two years).
Manufacture in Germany
VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine to receive marketing authorization in Europe for use as primary vaccination in people from 18 to 50 years of age.
The vaccine has also been granted conditional marketing authorization in the UK and emergency use authorization in the United Arab Emirates and Kingdom of Bahrain. Valneva currently has agreements to supply VLA2001 to certain EU Member States and the Kingdom of Bahrain.
However, the mega order from the EU (created last year after Valenva’s initial 2020 contract with the UK was dropped) ran into trouble in May with a delay in the authorization of the vaccine. While the vaccine has since been given the green light, the EU order has been cut to a fraction of its original size.
As per the commercial manufacturing services agreement signed in November 2021, IDT Biologika produced VLA2001 bulk vaccine at its Biosafety Level 3 facilities in Dessau-Roßlau, Germany, and Valneva bought the batches that were manufactured so far by IDT.
In light of the reduced European Commission order, Valneva has suspended manufacturing of the vaccine and, as compensation, will pay IDT up to €36.2m ($35.8m) in cash and the equivalent of €4.5m ($4.46m) in kind, in the form of specified equipment purchased by Valneva.
Valneva has started to deliver doses of VLA2001 to the European Member States who ordered the vaccine and is retaining inventory for potential additional supply to these Member States should demand increase.
Meanwhile, it is continuing discussions with other governments around the world, with the aim to deploy approximately eight to ten million doses of remaining inventory into international markets in the next six to twelve months.