Valneva SE announced this week that it will no longer prioritize centralized discussions with the European Commission regarding the distribution of its inactivated, adjuvanted COVID-19 vaccine candidate VLA2001 but instead move to bilateral, country-by-country discussions.
“We’ve committed significant time and effort to try to meet the needs of the central EC procurement process,” Thomas Lingelbach, CEO of Valneva, said. “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.”
To date, VLA2001 is the only inactivated vaccine candidate for COVID-19 in European clinical trials. Earlier this month, positive results came from a phase 1/2 clinical trial, and a phase three clinical trial is expected to begin by the end of April.
While Valneva began advanced discussions with the EC in January, they have not advanced to the company’s satisfaction. A separate collaboration with the UK government, announced in September 2020, will see up to 190 million doses of VLA2001 provided through 2025. The candidate is expected to be submitted for regulatory licensure in Europe in the autumn.