WASHINGTON: Johnson & Johnson said on Monday it had temporarily paused its Covid-19 vaccine candidate clinical trials because of an unexplained illness during a study participant, delaying one of the absolute best profile efforts to contain the worldwide pandemic.
The participant’s illness is being reviewed and evaluated by an independent data and safety monitoring board also because of the company’s clinical and safety physicians, the company said during a press release.
J&J, which reports quarterly financial results on Tuesday morning, said that such pauses are normal in big trials, which can include tens of thousands of people. It said the “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” required by health authorities. this case could also be an interruption.
However, J&J’s move follows a uniform one by AstraZeneca. In September, AstraZeneca paused late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, because of an unexplained illness during a UK study participant.
While trials within the united kingdom, Brazil, South Africa, and India have resumed, the US trial remains on hold pending a regulatory review.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of medicine, said by email that “Everybody is on the alert thanks to what happened with AstraZeneca,” adding that it could take hebdomadally to gather information.
“It would wish to be a big adverse event. If it had been something like prostate cancer, uncontrolled diabetes, or an attack – they might not stop it for any of those reasons. this is often likely to be a neurological event,” he said.
Last month, J&J said its experimental Covid-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, following which the company began a final 60,000-person trial, whose results had been expected by the highest of this year or early 2021.
Johnson & Johnson declined to elaborate on the illness because of privacy concerns. It did say that some participants in studies get placebos, and it had been not always clear whether a private suffering a big adverse event during a clinical trial received a placebo or the treatment.
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