CureVac’s First-Generation COVID-19 Vaccine Candidate, CVnCoV, Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation

01-Jun-2021 - Germany

CureVac N.V. announced that the independent Data Safety Monitoring Board (DSMB) has confirmed that the pivotal Phase 2b/3 study (HERALD) for CureVac’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. As a standard procedure within a blinded trial, CureVac has no access to trial data. 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 approximately 40,000 participants in ten countries in Latin America and Europe. Of those participants, approximately 75% were enrolled in Latin America and 25% in 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.

https://www.bionity.com/en/news/1171281/curevacs-first-generation-covid-19-vaccine-candidate-cvncov-continues-toward-phase-2b-3-efficacy-readout-in-variant-rich-environment-following-dsmb-recommendation.html