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CUREVAC the RNA people CureVac Provides Update on Phase 2b / 3 Trial of First - Generation COVID - 19 Vaccine Candidate , CVnCoV ● ● Pivotal study conducted in 10 countries in fast changing environment of at least 29 COVID - 19 variant strains ; original strain almost completely absent At second interim analysis , statistical success criteria not met . Favorable safety profile confirmed ● Initial analyses show trend for age and variant dependent efficacy ● Results communicated to EMA , study progressing to final analysis within the next few weeks . TÜBINGEN , Germany / BOSTON , USA - June 16 , 2021 - CureVac N.V. ( Nasdaq : CVAC ) , a clinical - stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ( " mRNA " ) , today announced results of the second interim analysis of its international pivotal Phase 2b / 3 study in approximatively 40,000 subjects ( the HERALD study ) of CureVac's first generation COVID - 19 vaccine candidate , CVnCoV . In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis , CVnCoV demonstrated an interim vaccine efficacy of 47 % against COVID - 19 disease of any severity and did not meet prespecified statistical success criteria . Initial analyses suggest age and strain dependent efficacy . Available data were communicated with the European Medicines Agency ( EMA ) . The Data Safety Monitoring Board ( DSMB ) confirmed a favorable safety profile for CVnCoV . The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway . In total , 134 Covid - 19 cases were assessed in this interim analysis . Out of these cases , 124 were sequenced to identify the variant causing the infection . The outcome confirms that only one single case was attributable to the original SARS - CoV - 2 virus . More than half of the cases ( 57 % ) were caused by Variants of Concern . Most of the remaining cases were caused by other less characterised variants such as Lambda or C.37 , first identified in Peru ( 21 % ) and B.1.621 , first identified in Colombia ( 7 % ) . In this context , the interim results suggest efficacy in younger participants but did not allow to conclude on efficacy in the age group above 60 . " While we were hoping for a stronger interim outcome , we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging . As we are continuing toward the final analysis with a minimum of 80 additional cases , the overall vaccine efficacy may change , " said Dr. Franz Werner Haas , Chief Executive Officer of CureVac . " In addition , the variant - rich environment underlines the importance of developing next - generation vaccines as new virus variants continue to emerge . " The HERALD study , conducted by Curevac in conjunction with Bayer , enrolled approximately 40,000 participants in ten countries in Latin America and Europe . The second interim analysis included 134