Curevac withdraws first Covid vaccine from approval process

The Tübingen biotech company Curevac is stopping its first Covid vaccine and withdrawing the vaccine from the approval process.

The company now wants to lead the way with a new, modified vaccine.

Will it work this time?

Tübingen - A few months after the publication of the comparatively weak effectiveness of its first Covid vaccine, the Tübingen biotech company Curevac wants to realign itself. CEO Franz-Werner Haas announced on Tuesday that the vaccine CVnCoV would be withdrawn from the approval process at the European Medicines Agency (EMA).

According to Haas, the company and its British partner GlaxoSmithKline (GSK) want to focus on developing further, better Covid-19 vaccines. Among other things, these should offer longer-lasting protection against new variants in a single vaccination. “We see that with CVnCoV we can no longer be part of the first wave of pandemic vaccines. But we have a firm intention to work with our partner to lead the way in the development of a new, improved second generation vaccine, ”said Haas.

It is assumed that the first vaccine would have been approved by the EMA in the second quarter of 2022 at the earliest, said Haas. However, there was no formal application for approval for the vaccine CVnCoV, CVnCoV was still in the so-called rolling process for approval. The EMA announced on Tuesday that it has now terminated this process of reviewing continuously submitted data about the vaccine following notification from Curevac.

In late June, Curevac announced that its first-generation CVnCoV vaccine was less effective than some other vaccines.

At the beginning of July, the biotech company assumed that the EMA would approve the vaccine despite its low effectiveness.

According to a final analysis, the Curevac preparation had shown an effectiveness of 48 percent against Covid 19 disease across all age groups.

This makes it significantly less effective overall than some other vaccines.

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As before, approval from the Medicines Agency EMA is still pending.

Consequences are now being drawn.

Curevac downsizes production network for Covid-19 vaccine

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According to Haas, the pre-produced cans will be destroyed. He didn't want to say how many there are. As a direct consequence of the end of the withdrawal, the preliminary contract with the European Commission, in which CVnCoV was provided for acute pandemic needs, said Haas. He does not assume that advance payments from the EU amounting to 450 million euros will have to be repaid. At that time it was assumed that the development of a vaccine required certain investments. "There was no advance payment for the cans to be delivered."

We are in talks with the federal government, which has shares in Curevac. Last year, the federal government invested 300 million euros in Curevac through the KfW development bank and, according to KfW, holds a 16 percent share. Haas was unable to comment on further contracts or possible repayments. "That would be too early". Curevac is examining to what extent the commitments made in this context can also be transferred to the second-generation vaccine candidates.

Curevac and GSK anticipate that they will enter clinical development in the next few months.

According to Haas, the goal is to achieve regulatory approval for an improved Covid-19 vaccine to be ready for the market in 2022.

Compared to the first vaccine, CV2CoV showed up to ten times higher immunogenicity in animal models.

dpa