New twist in Valneva’s turbulent journey. After receiving the British green light in mid-April for its anti-Covid vaccine, that of the European Medicines Agency (EMA) seemed imminent. A dramatic turn of events, the Franco-Austrian laboratory announced on Monday that it had received from the European Commission “a notice of intent to terminate the agreement to supply its candidate whole-virus inactivated vaccine against COVID-19, VLA2001”. The stock market reacted violently, and the price of the company specializing in vaccines collapsed by 20%.
The contract signed by Valneva with Europe in fact gives Brussels the right to terminate it if VLA2001 has not received marketing authorization from the EMA by April 30, 2022 at the latest. day, he still has not received the precious sesame.
Deadline June 13
Under the terms of the contract, Valneva has 30 days from May 13, 2022 to obtain an authorization from the EMA or to propose a plan to remedy the situation in an acceptable manner.
The company explains that it “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 those member states who still wish to obtain the vaccine”.
If the Commission finally terminates the contract at the end of the current process, Valneva would not be required to return the installments received. The laboratory has spent or committed the full amount of these deposits and the contract does not require reimbursement of these payments in this case.
“Following discussions with the commission and the member states concerned, Valneva will reconsider its financial forecasts for the 2022 financial year,” the company said.
Since mRNA vaccines are a world first having sparked a barrage of “antivax” accusing them of side effects, the traditional vaccine developed by Valneva can find its place in the landscape, by being better accepted by part of the opinion. public refractory to innovative vaccines, argues Valneva.
“We continue to receive messages from Europeans who are looking for a more traditional vaccine solution. We have started a dialogue with member states that are interested in our inactivated approach. Valneva continues to believe that its vaccine candidate VLA2001 can still make an important contribution to the fight against COVID-19,” said CEO Thomas Lingelbach.
The best solution would be for the laboratory based in Saint-Herblain (Loire-Atlantique) to obtain the green light from the EMA before the deadline of June 13. He responded on May 2 to a new list of questions from the EMA’s Committee for Medicinal Products for Human Use. If his answers are accepted, he could obtain a positive opinion from the Committee for Medicinal Products for Human Use by June at the latest.
He has some references to support him: in addition to a conditional marketing authorization in the United Kingdom, his vaccine has already had authorizations for emergency use in Bahrain on February 28, 2022 and then in the United Arab Emirates on May 13. 2022.