(BFM Bourse) – Slowed down by the additional questions addressed by the European Medicines Agency to Valneva, the process of examining the application for the marketing of its anti-Covid vaccine nevertheless continues to progress. This puts the company in a position to obtain or not within a few days the maintenance of an order of several tens of millions of doses.
The only certainty for Valneva about the soap opera that constitutes the proposed purchase by the European Commission of up to 60 million doses of the candidate vaccine against Covid-19 VLA2001: the outcome is near! But the future of this gigantic order is likely to be decided within a few days.
As the purchase contract signed in November 2021 allowed in the absence of approval on April 30, the European Commission has indeed notified the company of its intention to terminate the order if this approval does not succeed quickly. A sort of ultimatum giving Valneva 30 days from May 13 to obtain this marketing authorization or to propose “a plan to remedy the situation in an acceptable way”.
The complex regulatory process leading to a possible market launch has been delayed due to additional requests from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) relating to the VLA2001 dossier, to which Valneva responded.
Deadline until June 12
Giving hope to investors, the tricolor biotechnology company announced the crossing of an important step in the process in the form of the acceptance by the agency of the submission of the authorization file. In concrete terms, this means the phase of progressive data review is over to enter the formal evaluation phase. Therefore, Valneva thinks that the CHMP could deliver its opinion in June 2022. According to the calendar communicated by the agency, its committee must meet for the next time… between June 20 and 23, knowing that the deadline is short. so in principle until June 12th.
The formal decision rests with the European Commission (which in practice systematically follows the opinion of the Committee for Medicinal Products for Human Use).
“The acceptance by the EMA of the submission of the registration dossier for VLA2001 is an important step towards a marketing authorization for the product”, indicated Thomas Lingelbach, Chairman of the Management Board of Valneva, without taking the risk of prognosticating. a date. “We remain fully committed and are working together with regulatory authorities, European Union Member States and the European Commission to make more traditional and proven Covid-19 vaccination technology available to Europeans.”
A more classic inactivated virus vaccine
The firm is convinced that its vaccine can make an important contribution to the fight against the pandemic with a more traditional approach of inactivated whole virus likely to convince some people reluctant to more innovative technologies such as messenger RNA. In this context, apart from the approach undertaken at Commission level, Valneva has entered into a dialogue directly with certain Member States interested in the inactivated approach.
Furthermore, if the Commission finally terminates the contract at the end of the current process, Valneva has specified that it will not have to return the installments received.
Guillaume Bayre – ©2022 BFM Bourse
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