Benzinga | Mar 22, 2021 10:15AM EDT

CureVac Expands Late-Stage Trials Of COVID-19 Vaccine Candidate

CureVac BV (NASDAQ: CVAC) plans to expand and further specify the protocols of its ongoing late-stage clinical trials with CVnCoV, its COVID-19 vaccine candidate.

* CVnCoV efficacy is currently being evaluated in the pivotal HERALD Phase 2b/3 trial in Europe and Latin America. New virus variants in the countries where the study is conducted support the need for further analysis to determine the vaccine candidate's efficacy 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 vaccine efficacy objective. The study initially aimed to evaluate the safety, reactogenicity, and immunogenicity of CVnCoV in adults.

* The expanded analysis is expected to collect relevant efficacy data, which includes the important group of approximately 270 participants above the age of 60, treated with 12?g of CVnCoV.

* Data readouts from both clinical trials are expected in the second quarter of 2021.

* The company also reaffirms its intention to file for formal marketing authorization within the second quarter of 2021.

* Price Action: CVAC shares are trading 0.26% lower at $95.39 in market hours on the last check Monday.