CureVac Final Data from Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection in Age Group of 18 to 60
- Unique pivotal study conducted in 10 countries in fast changing variant environment; 15 COVID-19 variant strains present for efficacy analysis; original strain almost completely absent
- Statistical success criteria for primary endpoint met on basis of 228 adjudicated cases
- Vaccine efficacy of 48% against COVID-19 of any severity across all age groups and 15 variants
- Significant vaccine efficacy demonstrated in participants aged 18 to 60 and across all 15 variants:
- Efficacy of 53% against disease of any severity
- Efficacy of 77% against moderate and severe disease
- Full protection against hospitalization or death
- CureVac in ongoing dialogue with EMA; continuing regulatory submission
CureVac N.V., a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced results from the final analysis of its 40,000 subject international pivotal Phase 2b/3 study (the HERALD study) of the first-generation COVID-19 vaccine candidate, CVnCoV. In the unprecedented context of 15 strains circulating within the study population at the time of final analysis, CVnCoV demonstrated an overall vaccine efficacy of 48% (vaccine 83 vs. 145 placebo) against COVID-19 disease of any severity, including single non-respiratory mild symptoms. Significant protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% (vaccine 71 vs. 136 placebo) against disease of any severity and across all 15 identified strains; protection against moderate to severe disease was calculated to be 77% (9 vaccine vs. 36 placebo). In the same age group, CVnCoV provided 100% protection (vaccine 0 vs. 6 placebo) against hospitalization or death. In participants above 60 years, who represented 9% of the analysed cases, the available data did not enable a statistically significant determination of efficacy. The data confirm the favorable safety profile of CVnCoV in all age groups. The study will continue to complete follow-up analyses for trial participants. Available data have been communicated to the European Medicines Agency (EMA).