On Feb. 19, 2021, Johnson & Johnson announced that Janssen-Cilag had submitted for Emergency Use Listing (EUL) to the World Health Organization (WHO) for the investigational single-dose Janssen COVID-19 vaccine candidate.

The data package delivered included interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The Company’s rolling submission of clinical data to WHO was completed.

The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and UN procurement agencies. The EUL process expedites access to such products in many countries around the world and is also a prerequisite to supply vaccines to the new COVAX Facility, a global mechanism for pooled procurement and distribution of COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

In December 2020, the Company entered into an agreement in principle with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility. The Company and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Janssen vaccine to COVAX through 2022.

The Company filed for Emergency Use Authorization (EUA) in the United States on February 4, 2021 and submitted a Conditional Marketing Authorisation Application (cMAA) in the European Union on February 15, 2021. In addition, rolling submissions for the investigational single-dose COVID-19 vaccine have been initiated in several countries worldwide.