CureVac has reported data from the final analysis of Phase IIb/III HERALD clinical trial of its vaccine candidate, CVnCoV, which showed an overall efficacy of 48% against Covid-19 of any severity.
Last month, the company said that CVnCoV failed to meet prespecified statistical success criteria, demonstrating a 47% efficacy at the 40,000-participant trial’s second interim analysis.
The latest data revealed significant protection among subjects aged 18 to 60 years, with a 53% efficacy against any disease severity and across all 15 identified strains, the company noted.
The vaccine also had a 77% efficacy against moderate to severe Covid-19 and provided complete protection against hospitalisation or death in this age group.
Among subjects aged above 60 years, who were 9% of the analysed cases, the trial findings did not allow a statistically significant efficacy determination.
CureVac noted that the final analysis’ statistical success criteria were met based on 228 cases, which occurred a minimum of two weeks from the second dose, including 68 more adjudicated cases versus the 160 cases pre-defined according to the study protocol.
The results are said to validate the favourable safety profile of the Covid-19 vaccine in all age groups.
Meanwhile, the company will continue the trial to conclude follow-up evaluations for participants. Available results were submitted to the European Medicines Agency.
CureVac CEO Dr Franz-Werner Haas said: “In the current context of an increasingly diverse environment of Covid-19 variants, and with very little residual prevalence of the original strain, we are confident that the HERALD study offers clinically relevant data regarding the effect of emerging variants on vaccine efficacy.”
A total of 228 adjudicated Covid-19 cases were evaluated in the final analysis. In subjects aged 18 to 60 years, strain-dependent efficacy of the vaccine was nearly 42% to up to 67%, across higher incidence strains.
Of the 228 cases, 204 were sequenced to detect the variant responsible for the infection and were included in the efficacy assessment.