Johnson & Johnson said on Monday, October 12 that they have temporarily stopped its Covid-19 vaccine trial because one of its study participants developed an unexplained sickness.
"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," the company said in a statement.
As per the statement issued by Johnson & Johnson, the company is reviewing the cause of the participant’s illness. The company said they would evaluate and find the reason behind the occurrence of this illness by its in-house physicians and a safety monitoring panel.
Referring to the participant’s privacy, J & J has not revealed the details about the illness. The company also said that they were “learning more” and it is “important to have all the facts before we share additional information.”
The online enrollment system for 60,000 patient clinical trials has been closed while the independent patient safety committee is being assembled.
J&J said that serious adverse events are "an expected part of any clinical study, especially large studies." According to the company’s guidelines, they are allowed to pause a study to determine if the SAE was related to the drug in question and whether or when to resume study.
In a statement, J & J said, “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.”
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In late September, J&J started recruiting participants for its Phase 3 trial for which they enrolled up to 60,000 volunteers across more than 200 locations in the US and around the world, including countries like Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
In September, AstraZeneca also paused several trials of its COVID-19 vaccine globally, named as AZD1222, after an unexplained sickness occurred in a study participant. Likely, most trails have resumed in October.