In the absence of an agreement with the EU, the Valneva laboratory turns to country-by-country discussions



The laboratory is preparing a phase 3 study, the last before a possible authorization, which should start at the end of April – Viennareport / Sipa USA / SIPA

The laboratory believes that discussions with the EU have not made “significant progress”. Valneva – which announced at the beginning of April positive initial results for the first phase of its clinical study on its potential vaccine -, indicates that as a result, it will no longer give “priority to the centralized supply discussions currently underway with the European Commission “.

“We have spent a lot of time and effort trying to meet the demands of the centralized purchasing process of the European Commission,” said Thomas Lingelbach, CEO of the group, quoted in the statement, who regrets the absence of agreement with the EU. “We are now focusing our efforts on EU member states and stakeholders outside the EU who wish to include our inactivated approach in their vaccination strategy,” he continues.

Agreement with the United Kingdom

The European Union announced on January 12 that it had concluded “exploratory talks” with Valneva and considered purchasing up to 60 million doses. But no final agreement has been reached to date, even as vaccine supplies have suffered delays, exposing the EU to criticism for an immunization campaign less advanced than in its British neighbor in particular.

So far, vaccines from Moderna, Pfizer-BioNTech and AstraZeneca are available in the EU. The European Medicines Agency also estimated on Tuesday that the Johnson & Johnson vaccine, on which many countries rely to speed up immunization campaigns, can be used, due to a favorable benefit / risk ratio.

In the case of Valneva, based in Nantes, the United Kingdom, for its part, made an agreement in July 2020, before signing a partnership last September for a potential of 190 million doses purchased, for a maximum value. of 1.4 billion euros. The country has already ordered 100 million doses for 2021-2022, recalls Valneva in its press release Wednesday.

Phase 3 study

“The UK responded first, probably largely because we were already there, and also because they believed in our inactivated vaccine straight away. They were the first to react and to make a structured offer of assistance to us, ”explained Franck Grimaud, the managing director, at the beginning of February.

Valneva is developing a vaccine that uses the well-known inactivated virus technology, a process that creates an immune response in patients by injecting them with a virus deprived of its ability to harm. The laboratory is preparing a phase 3 study, the last before a possible authorization, which should start at the end of April, and hopes to put it on the market this fall.



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