The US-based multinational corporation Johnson & Johnson (J&J) said that due to an unexplained illness in a study participant, it has temporarily paused its COVID-19 vaccine candidate clinical trials, slowing one of the highest profile efforts to contain the worldwide pandemic.
The illness of the participant is examined and assessed by an independent data and safety control board as well as the clinical and safety physicians of the company, the company said in a statement.
J&J said that in large trials, which can involve tens of thousands of individuals, such pauses are common. It claimed that the “study pause” was different from a “regulatory hold” mandated by health authorities in giving doses of the vaccine candidate. The current case is a “study pause.”
J&J’s move follows a similar one by UK-based AstraZeneca Plc. In September, due to an unexplained illness in a UK study participant, AstraZeneca halted late-stage trials of its experimental coronavirus vaccine, developed together with the University of Oxford.
Although its trials have resumed in the UK, Brazil, South Africa and India, the US trial is still on hold as a regulatory review is pending.
Experts on infectious diseases say that, “Everybody is on the alert because of what happened with AstraZeneca,” adding that it could take a week to gather information.
“It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack – they wouldn’t stop it for any of those reasons. This is likely to be a neurological event,” they said.
Last month, in an early to mid-stage clinical trial following which the company conducted a final 60,000-person trials, the results of which were anticipated by the end of this year or early 2021, J&J announced that its experimental COVID-19 vaccine developed a powerful immune response against the novel coronavirus.
The vaccine from Johnson & Johnson stands out from the rest because it is the first one that might potentially be a single-shot vaccine. Moderna Inc, Pfizer Inc and AstraZeneca vaccines all need two shots separated by several weeks.
Because of privacy concerns, Johnson & Johnson refused to reveal more about the illness of the study participant. It was believed that some research participants were given placebo (a control used in drug testing) and it was not always clear if the study participant suffering from the severe adverse effect was given the placebo or COVID-19 vaccine under the clinical trial.
Reports suggest that the online system used to enroll patients in the study had been closed and the data and safety monitoring board would be convened.
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