Valneva, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.
Valneva’s vaccine candidate is based on a proven approach and will leverage the Company’s existing manufacturing platform being used for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine. VLA2001 entered Phase 1/2 clinical studies in December 2020 and Valneva expects to report initial safety and immunogenicity data in April 2021. Upon analysis of the data, Valneva will select the best dose and commence the second part of the Phase 1/2 clinical development. If clinical development is successful, an initial approval may be granted in the second half of 2021.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “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. We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic. We are deeply committed to providing broad access to our inactivated SARS-CoV-2 vaccine candidate and, as we proceed with clinical development, we will simultaneously continue working with partners, including the European Commission and the UK Government, to help us reach that goal. We increasingly see wider recognition that our vaccine will be one that the world cannot do without.”
In September 2020, Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its inactivated vaccine candidate, VLA2001. Under the partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021.