Valneva SE is now focusing on 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 VLA20011. Read more here.
 
Valneva previously announced the advanced stage of its discussions with the EC on January 12, 2021. In September 2020, Valneva entered 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 begin by the end of April 2021 with the aim of making regulatory licensure submissions in the autumn of 2021.

PHASE III Trial
The Phase 3 trial “Cov-Compare”, (VLA2001-301), will compare Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, against AstraZeneca’s conditionally approved vaccine, Vaxzevria, in a comparative immunogenicity trial.

Approximately 4,000 participants will receive two doses of either vaccine. The primary endpoint of Cov-Compare will be to determine the immune response of SARS-CoV-2-specific neutralizing antibodies two weeks after completion of a two-dose immunization schedule administered in a four-week interval. The trial will be conducted in the U.K. and is supported by the National Institute for Health Research.