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CureVac Expands COVID-19 Vaccine Candidate Analyses To Include Phase 2b/3 Variant Specification

CureVac N.V. (CVAC) said Monday that it plans to expand and further specify the protocols of its ongoing late-stage clinical trials with its COVID-19 vaccine candidate, CvnCoV.

The company is currently evaluating CVnCoV efficacy in the pivotal HERALD Phase 2b/3 trial in Europe and Latin America.

Rapid distribution of new virus variants in the countries where the study is conducted supports the need for further analysis specification for the anticipated case-driven interim analysis. It will allow to determine efficacy of the vaccine candidate for select variants.

The company said it has ongoing discussions with the European Medicines Agency to potentially include an amendment related to select virus strains in the study.

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 trial analysis is expected to allow for collection of relevant efficacy data which includes the important group of about 270 participants above the age of 60, treated with 12µg of CVnCoV.

CureVac expects data readouts from both clinical trials in the second quarter 2021. It also reaffirms its intention to file for formal marketing authorization within the second quarter 2021.

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