Valneva wins approval from European Commission to supply Covid-19 vaccines

12 November 2021

Valneva, a specialty vaccine company and member of Atlanpole Biotherapies, announced that the European Commission (“EC”) has approved an agreement pursuant to which Valneva would supply up to 60 million doses of VLA2001, its inactivated COVID-19 vaccine candidate, over two years including approximately 27 million doses in 2022.

Under the current terms of the agreement, the EC has the option to increase its initial purchase, in 2022, of VLA2001 up to a total of 60 million doses by the end of 2023. The agreement will be completed following final review, including volumes required, by each of the European Union Member States. Today’s announcement follows the conclusion of advanced exploratory talks with the European Commission that began in January 2021. Delivery of the vaccine is currently expected to begin in April 2022, subject to approval by the European Medicines Agency (EMA) human medicines committee (CHMP), which is expected to start a rolling review of VLA2001 shortly.

Thomas Lingelbach, Chief Executive Officer of Valneva, said, “We are grateful to the European Commission for its support and are eager to help address the ongoing pandemic. We continue to receive messages from people across the world who are waiting for an inactivated vaccine. We are deeply committed to bringing an alternative vaccine solution to the market as quickly as possible and continue to work tirelessly to achieve that. Our Phase 3 results confirmed the advantages often associated with inactivated vaccines and we continue to believe that our differentiated vaccine candidate could 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 respective teams in the EC and across Valneva who have worked assiduously on this agreement. We are looking forward to completing the agreement and getting the rolling review with EMA underway. Our recent Phase 3 data have allowed us to showcase the value of VLA2001 and we believe that other supply deals could follow this one.”

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.