the contract between Valneva and the European Union threatened

This is a situation that has a bit of deja vu for Valneva. The Franco-Austrian laboratory, based in Saint-Herblain (Loire-Atlantique), on the outskirts of Nantes, announced on Monday May 16 that it had received from the European Commission “a notice of intent to terminate the supply agreement » of its vaccine against Covid-19. A new disappointment for biotech, whose vaccine candidate has still not obtained the green light from the European Medicines Agency (EMA).

Bad luck does indeed seem to pursue the laboratory. The pharmaceutical group’s announcement recalls a similar communication eight months ago. This Monday, September 13, 2021, the laboratory then explained that it had been informed by the British government of the cancellation of its contract, relating to the delivery of 100 million doses in the United Kingdom. A very unpleasant surprise for Valneva, which saw in this agreement a springboard to move the company up a gear.

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History could repeat itself. The agreement signed with the European Commission, which provides for the purchase of 60 million doses of vaccines – of which almost 36 million are optional – gives the Brussels authority the right to put an end to it, because the vaccine developed by the biotech did not receive the approval of the AEM before April 30, 2022. If this exit door does indeed exist, no final decision has however yet been taken by the European executive. “Under the terms of the contract, Valneva has thirty days from May 13, 2022 to obtain marketing authorization or propose a plan to remedy the situation in an acceptable manner. »explains the Franco-Austrian laboratory, which, in the event of cancellation, will nevertheless not be required to reimburse the deposits received (approximately 30% of the total sum).

Convince Member States

The pharmaceutical laboratory, which has already started production of its bottles, hoped to receive marketing authorization on the Old Continent before May. Especially since, in the meantime, the company had obtained the green light from the British health authority, whose regulatory requirements are similar. But the MEA asked him, at the end of April, for additional data to be able to make a decision, postponing, once again, the potential arrival of the inactivated virus vaccine from Nantes on the European market.

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Coincidence of the calendar, the European health authority announced, Monday, May 16, the holding, this week, of the monthly session of its Committee for Medicinal Products for Human Use, the body responsible for evaluating applications for authorization of new medicines. . But Valneva’s vaccine was not on the agenda for talks over the next few days, leaving little hope now that the lab will get approval on time. The next meeting is scheduled to begin June 20, shortly after the 30-day deadline.

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