Valneva Switches Focus to Bilateral Discussions to Supply its Inactivated, Adjuvanted COVID-19 Vaccine Candidate VLA2001
Saint-Herblain (France), April 20, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today 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 VLA20011.
Valneva previously announced the advanced stage of its discussions, which started in the third quarter of 2020, with the EC on January 12, 20212. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 20253, 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.
About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease
SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The virus, which causes a disease named COVID-19, has never before been found in humans. Since this outbreak was first reported, the virus has caused millions of deaths globally4. It has been declared a pandemic by the World Health Organization (WHO).