J&J pauses COVID vaccine trials due to patient’s ‘unexplained illness’

Johnson & Johnson said last night in a statement: “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians…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. SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo…A study pause, in which recruitment or dosing is paused by the study sponsor, is a standard component of a clinical trial protocol. 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.”
Shares of Johnson & Johnson are down 2.4% to $148.19 in premarket trading.

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