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.
CureVac N.V., 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.