BRIEF—Phase III trial of Janssen's COVID-19 vaccine candidate initiated

Johnson & Johnson today announced the launch of its large-scale, pivotal, multi-country Phase III trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen companies.

The initiation of the ENSEMBLE trial follows positive interim results from the Company's Phase I/IIa clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.

These results have been submitted to medRxiv and are due to be published online imminently.

Based on these results and following discussions with the US Food and Drug Administration, ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

J&J has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year.

The company anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.