Johnson & Johnson Submits to WHO for Emergency-Use Listing of Covid-19-Vaccine Candidate
February 19 2021 - 7:24AM
Dow Jones News
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)
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