On Dec. 17, 2020, Johnson & Johnson announced that the large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) of the investigational Janssen COVID-19 single-dose vaccine candidate was fully enrolled with approximately 45,000 participants.

Given the high incidence of COVID-19 among the general population in the countries where the trial was conducted, this number of participants was sufficient to generate the data needed to determine the efficacy and safety of the Companyﾒs investigational COVID-19 vaccine candidate.