The countdown is on for the Franco-Austrian biotech Valneva


Will Brussels cancel its vaccine order? The biotech only has a few days left to obtain marketing authorization for its candidate vaccine from the European Medicines Agency.

VALNEVA

The countdown is on for Franco-Austrian biotech Valneva | Photo credits: Valneva

Tick-tock, tick-tock… The countdown has begun for Valneva. On May 16, the biotech announced in a press release that it had received from the European Commission “ a notice of intent to terminate the supply agreement for its inactivated whole-virus vaccine candidate against Covid-19, VLA2001 […] Valneva has 30 days from May 13, 2022 to obtain marketing authorization or to propose a plan to remedy the situation in an acceptable manner. “, added the press release. The deadline is fast approaching. What will be the outcome for Valneva? Will biotech get the Holy Grail for marketing its serum? Will it offer an alternative solution? Brussels plans to purchase 60 million doses of vaccines, including nearly 36 million as options.

Deposits not refunded

Given that no meeting of the Committee for Medicinal Products for Human Use is scheduled by June 12, we consider option 1 very unlikely. [d’autorisation de mise sur le marché]estimates the analyst of the firm Invest Securites. There therefore remains option 2, which consists of providing an acceptable remediation plan before the deadline, and to be approved by the EC and the Member States that may be interested in receiving doses of Valneva’s vaccine.. In the absence of a compromise, Brussels will be able to definitively terminate its contract with Valneva, which will however not be obliged to return the deposits received. ” There is another clause in the contract which specifies that Valneva would have the obligation to reimburse part of the upfronts incurred if a marketing authorization covering the entire adult population was not granted before June 30, 2022, and if some Member States requested it “recalls Invest Securities.

Valneva’s vaccine has already found a buyer. It has been approved in the United Arab Emirates and in Bahrain, which has ordered one million injections.


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