Debate about the contract is still ongoing: EMA allows the first dead Covid vaccine

Debate about the contract is still ongoing
EMA approves first dead Covid vaccine

The first inactivated vaccine is about to enter the market in the EU: the European Medicines Agency recommends the vaccine from the manufacturer Valneva for people between the ages of 18 and 50. The manufacturer recently questioned whether the substance could be produced at all.

A sixth Covid-19 vaccine is coming to market in the European Union. The European Medicines Agency (EMA) gave the green light for the vaccine from the French-Austrian biotech company Valneva. EMA’s competent committee recommended the vaccine for use as a primary vaccination in people aged 18 to 50 years. After a long wait, Valneva can now expect EU approval for its vaccine. The final decision rests with the European Commission, but its approval is considered a formality. Valneva shares rose 22 percent on the Paris Stock Exchange. In the European Union, it would be the sixth approved Covid-19 vaccine and the first so-called dead vaccine.

Valneva
Valneva 13.87

The vaccine contains the inactivated Sars-CoV-2 virus and two intensifiers. It is a classic technology that has been tried and tested for decades and is used in most influenza vaccines and many vaccines for childhood diseases. The mRNA vaccines from Biontech/Pfizer and Moderna, the two protein-based 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 as we have clear evidence that Europeans want a more traditional vaccine technology,” said Valneva CEO Thomas Lingelbach. The company wants to “offer a new option” to Europeans over the age of 18 who are not yet vaccinated.

Valneva recently questioned the future of its vaccine after the European Commission announced it might terminate the vaccine pre-purchase agreement due to delays in the approval process. Also because there is now an oversupply of vaccines in Europe, Valneva said she has signaled that she wants to change the agreement to a much smaller number of doses. According to Lingelbach, however, these are not sufficient to maintain the company’s vaccine program. According to Valneva, the company’s proposal for an amended contract will continue to be discussed by the Commission and member states.

The contract approved by the Commission at the end of 2021 actually provides that member states can buy almost 27 million doses of the vaccine this year. It also provides that the vaccine will be adapted to new variants and that member states can then order up to 33 million more doses in 2023. The prerequisite, however, was market approval in the EU by April 30th. This was delayed because the EMA had requested more information about the vaccine. The authority now came to the unanimous conclusion that the data on the vaccine “are robust and meet EU criteria for efficacy, safety and quality”.

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