Wednesday, November 24, 2021
Valneva SE, a specialty vaccine company, today announced that it has signed an Advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over two years. The agreement follows the announcement made earlier this month that the EC had approved the APA.
Under the terms of the agreement following final review of the volumes by each of the European Union (EU) Member States, Valneva expects to deliver 24.3 million doses during the second and third quarters of 2022, subject to approval of VLA2001 by the European Medicines Agency (EMA). The EC has the option to increase this initial firm purchase order up to a total of 60 million doses, the remainder of which would be delivered in 2023.
Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We are extremely pleased that the European Commission and the Member States have completed this purchase agreement and are eager to help address the ongoing pandemic. We continue to receive messages from people across the world requesting access to an inactivated vaccine. Our Phase 3 results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate can make an important contribution to the global fight against the COVID-19 pandemic.”
Franck Grimaud, Chief Business Officer of Valneva, commented, “I would like to express my thanks to the EC teams and the EU Member States who have placed VLA2001 orders. We are looking forward to getting the rolling review with EMA underway now that the rapporteurs have been appointed. The latest COVID-19 wave in Europe underlines the need for an alternative vaccine and we have some vaccine inventory ready to be used as soon as we receive EMA approval. Confirmation of the EC agreement will also allow us to optimize our manufacturing strategy for VLA2001.”
Valneva reported positive Phase 3 results for VLA2001 in October 2021. VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against the active comparator vaccine, AstraZeneca’s AZD1222, as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile.