Valneva Switches Focus to Bilateral Discussions to Supply its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001

Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, announced it is now focusing on bilateral discussions, on a country by country basis, to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

This follows the recent announcement on April 6, 2021 of positive initial results from the Phase 1/2 clinical trial of VLA2001.

Valneva previously announced the advanced stage of its discussions, which started in the third quarter of 2020, with the EC on January 12, 2021. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 2025, of which 100 million doses have already been ordered.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We’ve committed significant time and effort to try to meet the needs of the central EC procurement process. Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement. We are therefore now focusing our efforts on those European Union member states, and interested parties outside the EU, who would like to include our inactivated approach within their vaccination strategy. We are convinced that VLA2001 has an important role to play in the future, including boosters or potential modifications to the vaccine to address variants.”

Valneva has the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe and  is preparing a pivotal, comparative immunogenicity Phase 3 clinical trial expected to commence by  the end of April 2021 with the aim of making regulatory licensure submissions in the autumn of 2021.