What Happened: The pharmaceutical company reportedly told the researchers conducting the trial that the “pausing rule” has been met.
Johnson & Johnson has stopped enrolling new participants for the study and an independent committee will now probe the safety of the trial participants, according to Stat.
“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the New Brunswick, New Jersey-based company said.
It isn’t immediately clear whether the participant was administered the COVID-19 vaccine or a placebo. According to the company, serious adverse events "are not uncommon in clinical trials," and "can reasonably be expected to increase in trials involving large numbers of participants."
Why It Matters: Johnson & Johnson announced the initiation of the Phase 3 trial of its COVID-19 vaccine in late September, saying, the first batch of participants was already dosed.
The company ultimately intended to enroll up to 60,000 participants across three continents in the study.
Johnson & Johnson reported positive interim data from early-stage clinical trials.
The clinical trials of AstraZeneca plc’s AZN coronavirus vaccine candidate also remain paused in the United States after a participant developed symptoms related to a serious neurological disorder.
Moderna Inc. MRNA and Pfizer Inc. PFE/BioNTech SE — ADR BNTX also have their COVID-19 vaccine candidates in the Phase 3 clinical trial stage.
Experts have suggested vaccine trials getting paused is usually an encouraging sign. The pharmaceutical companies’ “first obligation is to the participants in the trial,” Johns Hopkins bioethicist Ruth Faden told Stat in an interview last month.
Price Action: Johnson & Johnson shares traded 0.26% higher at $152.24 in the after-market session Monday.
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