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(Reuters) – Johnson & Johnson said it had temporarily halted its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the most high-profile efforts to contain the global pandemic.
The participant’s illness is being reviewed and evaluated by an independent safety and data monitoring board, as well as the company’s safety and clinical physicians, the company said https://www.jnj.com/our-company/ johnson-johnson-temporarily-pauses-all-doses-in-our-clinical-trial-vaccine-candidates-janssen-covid-19-in a statement.
J&J, which reports quarterly financial results Tuesday morning, said such pauses are normal for large trials, which can include tens of thousands of people. He said the “study pause” to administer doses of the candidate vaccine was different from a “regulatory suspension” required by health authorities. The current case is a pause.
However, the J&J move follows a similar one from AstraZeneca. In September, the British group halted late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, due to an unexplained illness in a British study participant.
Both candidates are based on an adenovirus, a harmless modified virus that instructs human cells to make vaccine proteins, and both are part of the US government’s Operation Warp Speed program to support vaccine development. .
“This could be a second case of adenoviral vaccine to raise safety concerns,” said Bryan Garnier analyst Olga Smolentseva.
J&J became the fourth Warp-Speed participant to enter the final stage of human testing on September 22, with the goal of enrolling 60,000 volunteers in the United States and abroad. While Astra testing in Britain, Brazil, South Africa and India have resumed, the US trial is still on hold, pending regulatory review.
Dr. William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine, said by email that “everyone is on the lookout for 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. It’s likely a neurological event,” he said. . Last month, J&J said its experimental COVID-19 vaccine produced a strong immune response against the new coronavirus in an early to mid-stage clinical trial. This prompted the company to begin full-scale testing, with results expected by the end of this year or early 2021.
J&J declined to elaborate on the illness due to privacy concerns. He said that some study participants receive placebos, and it was not always clear whether a person who suffered a serious adverse event in a clinical trial received a placebo or the treatment.
Stat News reported https://www.statnews.com/2020/10/12/johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_medium= social & utm_source = twitter & utm_campaign = twitter_organic the pause at the beginning of the day citing a document sent to external researchers, which indicated that a “pause rule” had been met, the online system used to enroll patients in the study was had closed and the Data and Security Monitoring Board would be convened.
(Reporting by Ayanti Bera in Bengaluru, Deena Beasley in Los Angeles, Peter Henderson in Oakland, Ludwig Burger in Frankfurt; Edited by Rashmi Aich and Louise Heavens)
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