The contract signed between the European Commission and the group gave the Commission the right to terminate it if the vaccine developed by Valneva, called VLA2001, had not received marketing authorization from the Agency Medicines European Union (EMA), no later than April 30, 2022, recalls Valneva.
“Under the terms of the contract, Valneva has 30 days from May 13, 2022 to obtain marketing authorization or propose a plan to remedy the situation in an acceptable manner,” Valneva said.
The group "will work together with the European Commission and the member states participating in the agreement to agree on such a plan and make VLA2001 available to member states wishing to obtain the vaccine", he adds.
At the end of April, Valneva had received a new list of questions from the EMA.
In Monday's statement, the group's chief executive, Thomas Lingelbach, said he "answered these questions on May 2" and "believes that his submission provides sufficient answers to the remaining questions".
If the EMA "accepts these answers", Valneva "could obtain a positive opinion no later than June 2022".
He describes the decision of the European Commission as "regrettable", "especially since we continue to receive messages from Europeans who are looking for a more traditional vaccine solution".
Valneva's vaccine is based on an inactivated virus.
Compared to the anti-Covid vaccines authorized in the EU, it is a more traditional technology than the Pfizer/BioNTech or Moderna vaccines, with messenger RNA, and, to a lesser extent than those of AstraZeneca and Johnson & Johnson, with viral vector, or that of Novavax, with recombinant protein.
© 2022 AFP