Pivotal Study of J&J's Covid-19 Vaccine to Resume, Company Says

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 [e-mail]

(END) Dow Jones Newswires

October 23, 2020 16:58 ET (20:58 GMT)

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