Krisitn Brooks03.22.21
CureVac N.V. plans to expand and further specify the protocols of its ongoing late-stage clinical trials with its COVID-19 vaccine candidate, CVnCoV.
CVnCoV efficacy is currently being evaluated in the HERALD Phase 2b/3 trial in Europe and Latin America. New virus variants in the countries where the study is conducted supports the need for further analysis to determine efficacy of the vaccine candidate for select variants.
For its Phase 2a dose-confirmation trial in older adults in Peru and Panama, CureVac has submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate safety, reactogenicity and immunogenicity of CVnCoV in adults. Expanded analysis is expected to allow for collection of relevant efficacy data which includes the important group of approximately 270 participants above the age of 60, treated with 12μg of CVnCoV.
CureVac expects data from both trials in 2Q21. It also reaffirms its intention to file for formal marketing authorization in 2Q21.
CVnCoV efficacy is currently being evaluated in the HERALD Phase 2b/3 trial in Europe and Latin America. New virus variants in the countries where the study is conducted supports the need for further analysis to determine efficacy of the vaccine candidate for select variants.
For its Phase 2a dose-confirmation trial in older adults in Peru and Panama, CureVac has submitted a protocol amendment to include a secondary objective for vaccine efficacy. The study initially aimed to evaluate safety, reactogenicity and immunogenicity of CVnCoV in adults. Expanded analysis is expected to allow for collection of relevant efficacy data which includes the important group of approximately 270 participants above the age of 60, treated with 12μg of CVnCoV.
CureVac expects data from both trials in 2Q21. It also reaffirms its intention to file for formal marketing authorization in 2Q21.
