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Johnson & Johnson said on October 12 it has temporarily paused clinical trials of its own COVID-19 vaccine candidate because of an unexplained illness in a research participant. In a statement, the company said that the participant’s illness has been reviewed and assessed by an independent data and safety monitoring board, and its clinical and security doctors.
J&J did not reveal details about the participant’s illness citing privacy. The company also said that they were”learning more” and it’s”important to have all the facts before we discuss additional details.”
A serious adverse event, or SAE, isn’t rare in clinical trials, J&J said in its announcement. “The amount of SAEs can reasonably be anticipated to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it’s not always immediately apparent if or not a participant received a study treatment or a placebo.”
Earlier in the afternoon, Stat News had reported that the pause citing a record sent to outside researchers conducting the clinical trial, which said that a”pausing rule” was met, the online system used to enrol patients in the study was closed and the data and safety monitoring board could be convened.
In September, AstraZeneca had paused several worldwide trials of its COVID-19 vaccine candidate, AZD1222, after an unexplained illness in a study participant. The majority of these trials resumed earlier this month.
