Covid-19: Valneva’s vaccine approved by the European Medicines Agency



A sixth vaccine against Covid-19 and approved by health authorities could soon see the light of day on the European market. The European Medicines Agency (EMA) approved on Thursday June 23 the coronavirus vaccine from the Franco-Austrian biotech company 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.

Limited ability to fight variants

“The EMA has recommended the granting of a marketing authorization for the vaccine” Valneva for people “aged 18 to 50”said the European regulator. “After a thorough assessment, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded by consensus that the data on the vaccine were robust and met EU criteria for efficacy, safety and efficacy. quality “he added.

The data showed that the vaccine triggers the production of higher levels of antibodies against the original strain of Covid-19 for patients aged 18 to 50, said the EMA, which is headquartered in Amsterdam. However, it was not possible to draw a conclusion on the ability of the vaccine to trigger the production of antibodies in people over 50 years of age.

The data is also “limited” on the ability of the vaccine to protect against variants of concern, including Omicron subvariants, which are currently the dominant strains in many EU countries.

Side effects seen with the vaccine were generally mild and resolved within a few days after vaccination, and included fatigue, headache, muscle aches and nausea. The European Commission will now speed up the decision-making process to grant a marketing authorization decision.

Disappointments

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.

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 try to remedy the situation in an acceptable way and 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.

The serum was approved in the UK in April, and is authorized in the United Arab Emirates and the Kingdom of Bahrain, the only country where it is currently marketed.

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