Valneva SE and the European Commission (EC) are discussing the possibility of the specialty vaccine company supplying up to 60 million doses of its inactivated, adjuvanted COVID-19 vaccine, VLA2001, for use throughout Europe.
“Today’s announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of VLA2001,” Thomas Lingelbach, CEO of Valneva, said. “We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic.”
VLA2001 is the only inactivated vaccine candidate currently in clinical trials for use against COVID-19 in Europe. A previous agreement, announced in September 2020, guaranteed 190 million doses of the vaccine candidate for the UK government. It utilizes a manufacturing platform already being used by the U.S. Food and Drug Administration and European Medicines Agency for an approved Japanese encephalitis vaccine.
The candidate entered phase 1/2 clinical studies in December 2020 and should provide initial safety and immunogenicity data in April 2021. The data from those studies will determine the best dose for use in the second part of phase 1/2 clinical development. If clinical development is successful, Valneva estimates an initial approval could be reached within the second half of this year.