Johnson & Johnson Submits to WHO for Emergency-Use Listing of Covid-19-Vaccine Candidate

By Michael Dabaie

Johnson & Johnson said Janssen-Cilag International NV submitted for emergency-use listing to the World Health Organization for the investigational single-dose Janssen Covid-19-vaccine candidate.

The data package delivered Friday includes interim efficacy and safety results from the Phase 3 ENSEMBLE clinical trial. The company's rolling submission of clinical data to WHO is now complete, Johnson & Johnson said.

The EUL procedure streamlines the process by which new or unlicensed products can be assessed for use during public health emergencies by governments and U.N. procurement agencies, the company said.

The EUL process expedites access to such products in many countries 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, Johnson & Johnson said.

Johnson & Johnson filed for emergency-use authorization in the U.S. on Feb. 4 and submitted a conditional marketing authorization application in the European Union on Feb. 15. In addition, rolling submissions for the investigational single-dose Covid-19 vaccine have been initiated in several countries worldwide, Johnson & Johnson said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

February 19, 2021 08:09 ET (13:09 GMT)

Johnson and Johnson (NYSE:JNJ)
Historical Stock Chart
From Mar 2024 to Apr 2024