EMA is reviewing Valneva’s new corona vaccine

Status: 02.12.2021 3:24 p.m.

The European Medicines Agency EMA wants to accelerate the testing of the corona vaccine from the French pharmaceutical company Valneva. It has a special feature compared to the previously approved vaccines.

The European Medicines Agency (EMA) has started accelerated testing of the corona vaccine VLA2001 from the French pharmaceutical company Valneva. The examination takes place as a so-called rolling process, said the Amsterdam-based EU authority. With this approach, the agency’s experts can review data from ongoing studies as soon as they are available. As usual, there is no waiting until all data from the clinical studies are available.

Convincing also for vaccination skeptics?

The dead vaccine contains components of the coronavirus that have been killed for immunization. This means that it uses a technology similar to that of classic flu vaccines and therefore does not have to be stored in ultra-low freezers.

No dead vaccine against Corona has yet been approved in the EU. BioNTech / Pfizer and Moderna funds are manufactured using the novel mRNA technology, AstraZeneca and Johnson & Johnson funds are vector vaccines. Traditional dead vaccines arouse interest from people like the German national soccer player Joshua Kimmich who have reservations about immunization with mRNA vaccines or vector vaccines.

Encouraging interim results

In October, Valneva announced the first “positive” results from the phase three clinical trial with the vaccine. The agent was more effective than the vaccine from the British company AstraZeneca and “generally well tolerated,” it said.

The EMA did not provide a timeframe for a possible approval of the vaccine. Once enough data is available, the company can submit a formal application for marketing authorization to the EMA.

Up to 60 million cans

Last month, the EU Commission had already signed a contract for the purchase of almost 27 million cans of VLA2001 in 2022. The contract also includes the ability to adapt the vaccine to new variants of the coronavirus and purchase up to 33 million additional doses in 2023.

In contrast, the British government had terminated a supply contract with Valneva in September. One reason for this decision was that the vaccine was not expected to be approved by the local regulatory authority.

Novavax is a little further ahead

Another corona vaccine could come from Novavax. The US pharmaceutical company applied for approval for its vaccine Nuvaxovid in mid-November.

In addition to the two vaccines mentioned, the EMA is currently also testing Sputnik from Russia and Sinovac from China in a rolling process.


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