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Risky business:
researchers at
Curevac
Photo: ANDREAS GEBERT / REUTERS
Serious setback for Curevac. The corona vaccine candidate CVnCoV missed the statistical targets in a second interim analysis. The Tübingen-based company announced this in a mandatory announcement on Thursday night. "In a previously unprecedented environment with at least 13 variants within the subset of study participants examined in this interim analysis, CVnCoV achieved a preliminary effectiveness of 47 percent against COVID-19 disease of any severity and thus did not meet the specified statistical success criteria." The CureVac share traded in the USA collapsed in after-hours trading by more than 50 percent.
Curevac boss
Franz-Werner Haas
(51) and his predecessor, Curevac founder
Ingmar Hoerr
(53), recently had to put off investors and the public again and again. While competitors such as Biontech or Moderna, whose products are also based on mRNA technology, have long been on the market, Curevac has so far not even been able to complete the necessary study for approval. The interim results now presented are part of the study design.
According to the mandatory notification, Curevac carried out the study together with Bayer in ten countries. The basis was around 40,000 subjects. The data from 134 test subjects were included in the second interim result that has now been presented - such small numbers are typical in the study designs. One problem: Due to the rapid mutation of the virus strains, the original virus variant is hardly available, according to the company. Initial analyzes have shown that the effectiveness depends on the age group examined and the strain of the virus, it said. The
"We had hoped for stronger results in the interim analysis, but we saw that with this unprecedented range of variants it is a challenge to achieve high effectiveness," said Haas.
He still wants to continue the study until the final analysis.
"The final effectiveness could still change," said the CEO.
"The diverse environment also shows that the development of second generation vaccines is very important as new variants keep emerging."
Curevac has submitted the data to the European approval authority EMA.
According to the company, the Data Safety Monitoring Board (DSMB) has confirmed a good safety profile.
An initial interim analysis did not reveal any safety concerns.