The debate over the agreement is still ongoing: EMA approves first dead vaccine against Covid

The debate on the agreement is still ongoing
The EMA has approved the first dead vaccine against Covid

The first inactivated vaccine is about to enter the EU market: the European Medicines Agency recommends a vaccine from Valneva for people aged 18 to 50. The manufacturer recently questioned whether the substance could be manufactured at all.

The sixth Covid-19 vaccine is launched in the European Union. The European Medicines Agency (EMA) has given the green vaccine from the Franco-Austrian biotechnology company Valneva. The relevant EMA committee recommended that the vaccine be used as primary vaccination in people aged 18 to 50 years. After a long wait, Valnev can now expect EU approval for her vaccine. The final decision rests with the European Commission, but its approval is considered a formality. Valneva’s shares on the Paris Stock Exchange rose 22 percent. It would be the sixth approved Covid-19 vaccine in the European Union and the first so-called dead vaccine.

Valneva
Valneva 14.36

The vaccine contains inactivated Sars-CoV-2 virus and two enhancers. It is a classic technology that has been tested for decades and is used in most influenza vaccines and many childhood vaccines. mRNA vaccines from Biontech / Pfizer and Moderna, two protein vector vaccines from Astrazeneca and Johnson & Johnson and Novavax are already on the market.

“We hope that the European Commission and its Member States will recognize the potential benefits of an inactivated vaccine and place a meaningful order because we have clear evidence that Europeans want more traditional vaccine technology,” said Valneva CEO Thomas Lingelbach. For Europeans over the age of 18 who have not yet been vaccinated, the company wants to “offer a new opportunity”.

Valneva recently questioned the future of her vaccine after the European Commission announced she could terminate the vaccine pre-purchase agreement due to delays in the approval process. Also because there is now a surplus of vaccines in Europe, Valneva said she indicated she wanted to change the deal to a much smaller number of doses. However, according to Lingelbach, these are not enough to maintain the company’s vaccination program. According to Valnev, the company’s proposal for a modified contract will continue to be discussed by the Commission and the Member States.

In fact, the agreement approved by the Commission at the end of 2021 stipulates that Member States can buy almost 27 million doses of the vaccine this year. It also stipulates that the vaccine will be adapted to the new variants and that Member States may then order up to 33 million additional doses in 2023. However, the precondition was the approval of the EU market by 30 April. This was delayed because the EMA requested more information about the vaccine. The Authority now came to the unanimous conclusion that the vaccine data “are reliable and meet EU criteria for efficacy, safety and quality”.

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