Pivotal Study of J&J's Covid-19 Vaccine to Resume, Company Says
October 23 2020 - 5:13PM
Dow Jones News
By Peter Loftus
Johnson & Johnson said Friday it is preparing to resume a
large clinical trial of its experimental Covid-19 vaccine, saying
it has found no evidence the vaccine caused a serious medical event
in a study volunteer.
J&J had paused the trial earlier this month, citing an
unexplained illness in a person enrolled in the trial. The trial
began in September and is aiming to enroll up to 60,000 people in
the U.S. and several other countries, to test whether a single dose
safely protects people from Covid-19.
J&J said Friday an independent data safety and monitoring
board has recommended resuming recruitment of study subjects for
the trial. The New Brunswick, N.J., company consulted with U.S.
regulators and is taking steps to resume the trial. It is also in
discussion with regulators in other countries to resume testing
there.
J&J didn't provide further details about the nature of the
medical event in the study subject. The company said many possible
factors could have caused it, and no clear cause has been
identified.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
October 23, 2020 16:58 ET (20:58 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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