France's Leading COVID-19 Vaccine Candidate Begins Bilateral Negotiations

Valneva SE today announced it is now focusing on bilateral country discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

Saint-Herblain, France -based Valneva previously announced the advanced stage of its discussions 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, CEO of Valneva, stated in a press release issued on April 20, 2021, “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.”

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

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 to make regulatory licensure submissions in the autumn of 2021.

The VLA2001 vaccine candidate is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018.

This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has shown a shift of the immune response towards Th1.

Valneva is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need.