29.05.2021 06:39:54
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CureVac Says COVID-19 Vaccine Passed First Analysis
(RTTNews) - CureVac N.V. (CVAC) said that the independent Data Safety Monitoring Board or DSMB has confirmed that the pivotal Phase 2b/3 study, dubbed as HERALD, for the company's first-generation COVID-19 vaccine candidate, CVnCoV, has passed a first interim analysis at 59 adjudicated COVID-19 cases.
The DSMB confirmed that there were no safety concerns for CVnCoV. The trial will continue to collect sufficient data in order to conduct statistically significant efficacy analysis.
The HERALD trial is conducted in an environment characterized by the spread of multiple virus strains. COVID-19 cases within the trial are currently being sequenced to provide critical complementary data to the efficacy readout.
The HERALD study has enrolled about 40,000 participants in ten countries in Latin America and Europe. The primary objective of the HERALD study is to demonstrate the efficacy of a two-dose administration of 12µg of CVnCoV in preventing COVID-19 infection of any severity in participants without prior exposure to SARS-CoV-2.
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