The Tübingen vaccine manufacturer CureVac has to cope with a severe setback.
As the company, which has been listed on the Nasdaq since last year, announced on Wednesday evening, the corona vaccine did not meet “statistical success criteria” in a second interim analysis of 134 cases.
However, the approval-relevant review with around 40,000 test subjects should be continued, it said.
The stock market price dropped by more than half in after-hours US trading on Wednesday.
Ilka Kopplin
Editor in business.
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According to this, the vaccine, which, like the vaccines from competitors BioNTech and Moderna, is based on mRNA technology, was only 47 percent effective against Covid-19 disease of any severity in a “previously unprecedented environment with at least 13 variants” it in the message. Initial analyzes have shown that the effectiveness depends on the age group examined and the virus strains.
Recently, doubts about the vaccine had increased, as the Tübingen biotech company actually wanted to get the vaccine approved in the second quarter.
In the spring, the company had to adapt the study protocol due to the large number of variants.
A few days ago, Berlin circles around Federal Health Minister Jens Spahn (CDU) said that the vaccine would not come before August.
This news had already sent the share price plummeting back then.
Just a case with the original virus variant
“We had hoped for stronger results in the interim analysis, but we saw that it is a challenge to achieve a high level of effectiveness with this unprecedented range of variants. We will continue the study with at least 80 more cases until the final analysis. The final effectiveness could still change, ”said CEO Franz-Werner Haas.
The study will be carried out in ten countries in Latin America and Europe. In the second interim analysis, 134 cases were examined that occurred at least two weeks after the second vaccination, it said. According to the company, 124 of these were sequenced in order to identify the variants that triggered the respective infection. Accordingly, only one case was the original virus. More than half of the cases were caused by so-called "Variants of Concern". Most of the remaining cases therefore existed in less researched variants such as Lambda or C.37, which first appeared in Peru, and B.1.621, which first appeared in Colombia. An effectiveness was registered in younger study participants,while no conclusions could be drawn about the effectiveness of participants older than 60 years. The data have now been transmitted to the European Medicines Agency (EMA).
Competitors were quicker to develop
About a year ago, the German state invested around 300 million euros in the Tübingen-based company.
In late summer, the company was listed on the New York technology exchange Nasdaq.
But while the competitors Moderna and BioNTech with their partner Pfizer received their first approvals in important markets around six months ago, CureVac only started the approval-relevant study at the end of last year.
In the past few months, several vaccines have been approved and inoculated millions of times around the world.
At the same time, however, other virus variants emerged that increasingly supplanted the original virus for which the CureVac vaccine and its study protocol were designed.
CEO Haas said: "Due to the varied environment, it also shows that the development of second-generation vaccines is very important, as new variants keep emerging." The Tübingen-based company is working on a second generation of a corona vaccine candidate in a partnership with the British company - Swedish pharmaceutical company Glaxo-Smith-Kline (GSK). A clinical study is expected to begin in the third quarter and the market launch is planned for the coming year, subject to the approval of the authorities.