On Sept. 23, 2020, Johnson & Johnson announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies.

The initiation of the ENSEMBLE trial followed positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. ENSEMBLE planned to enroll up to 60,000 volunteers across three continents to study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.