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Press Release

October 13, 2020
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Johnson & Johnson halts COVID-19 vaccine trials due to ‘unexplained illness’

Source:

Press Release

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Johnson & Johnson said it has temporarily paused dosing for all of its COVID-19 vaccine trials — including a phase 3 trial that began last month — because of an “unexplained illness” in a study participant.

The phase 3 trial, which began enrolling volunteers in September, is testing the efficacy of a single-dose candidate for the virus.

In a press release, Johnson & Johnson said the participant’s illness is being reviewed and evaluated by physicians and the study’s data safety and monitoring board.

“We must respect this participant’s privacy,” the company said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

Johnson & Johnson noted the “significant distinction” between a sponsor pausing a study and a regulatory hold, which is initiated by a regulatory authority such as the FDA.

“A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol,” the company said. “As noted in the ENSEMBLE study protocol, Johnson & Johnson has robust mechanisms in place to protect the safety of participants in its clinical trials. While the company informs all study investigators, we typically do not communicate study pauses publicly.”

In September, AstraZeneca also halted a COVID-19 vaccine trial because of an adverse reaction in a participant. In a recent interview, Paul A. Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told Healio that pauses in vaccine trials can be “a good thing” because it shows that sponsors are being careful.

“You want to be very careful about safety issues,” Offit said.