“CVnCoV demonstrated an interim vaccine efficacy of 47 percent against Covid-19 disease of any severity and did not meet prespecified statistical success criteria,” CureVac said in a statement.
The company blamed the “unprecedented context of at least 13 variants circulating within the study population subset assessed” for the disappointing result, as well as varying responses across different age groups.
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CureVac said it had communicated the results of the Phase 2b/3 study of 40,000 people in 10 countries to the European Medicines Agency (EMA) and is expecting to conduct a final analysis in the next few weeks.
“While we were hoping for a stronger interim outcome… demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” said CureVac CEO Franz-Werner Haas, adding that the “overall vaccine efficacy may change”.
The setback for CureVac comes on top of delays as its late-stage trial was slowed by the wait for enough participants to catch Covid.
CureVac initially expected to seek European approval for its jab in the second quarter, with Germany pencilling in 1.4 million doses by end-June, but regulatory authorisation is now not expected to come before August.
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Like the highly effective vaccines developed by faster rivals BioNTech/Pfizer and Moderna, CureVac’s shot is based on novel mRNA technology.
The German firm, founded in 2000 by mRNA pioneer Ingmar Hoerr, announced in interim results late May that independent analysis “found no safety concerns” with its vaccine.
Despite being a laggard in the vaccine race, CureVac believes it has advantages over its mRNA competitors.
CureVac’s product can be stored at standard refrigerator temperature, unlike the first-generation Pfizer and Moderna vaccines which require super-cold freezers.
CureVac’s vaccine also needs a lower dosage, allowing for faster and cheaper mass production.
The European Union has secured up to 405 million doses of the CureVac vaccine.