Covid-19: Valneva takes a decisive step towards the authorization of its vaccine

The Committee for Medicinal Products for Human Use, which depends on the European Medicines Agency, “recommended” the marketing authorization of Valneva’s vaccine against Covid-19, the Franco-Austrian biotech announced on Thursday, crossing thus a crucial step. This recommendation concerns the use of the Valneva vaccine in adults aged 18 to 55, adds in a press release the group, which had suspended its title on the stock market Thursday morning.

A decision expected soon in the EU

The European Commission will examine the recommendation of the Committee for Medicinal Products for Human Use and “a decision on the marketing authorization application for VLA2001 (the name of the vaccine: editor’s note) in Europe is expected soon”, adds Valneva. Nantes-based company Valneva is developing an inactivated virus vaccine, a more traditional technology than messenger RNA. This is also one of the arguments put forward by the laboratory, which believes that this vaccine could convince people who have not yet been vaccinated.

Valneva has multiplied the disappointments for this vaccine: in September 2021, the British government, which had placed an order for 100 million doses, terminated its contract, a disappointment for the company which had caused its stock price to fall. The United Kingdom, where this vaccine was also authorized in 2022, then claimed that biotech had failed in its obligations. Valneva and the UK government have since reached an amicable settlement, after months of negotiations.

Valneva calls for more orders to maintain its contract

In May, it was the turn of the European Union, with which Valneva had an agreement for 60 million doses by 2023, to let it be known that it was considering terminating this order, in a context of significant global production. In response, Valneva has proposed a plan to attempt to remedy the situation in an acceptable manner, which the European Commission must consider. Umpteenth episode in this soap opera: last Friday, the biotech called for more orders from European countries for its vaccine in order to be able to maintain this contract.

In addition to the United Kingdom, the vaccine is authorized in the United Arab Emirates and in the Kingdom of Bahrain, the only country where it is currently marketed. The European Union has, to date, approved 5 vaccines against Covid-19: those of Pfizer-BioNTech, Moderna, AstraZeneca, Johnson & Johnson and Novavax.

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