Setback: Johnson and Johnson halts Covid vaccine trial over unexplained illness in participant
The participant's illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company's clinical and safety physicians, Johnson and Johnson said in a statement.
Advertisement
Washington: Johnson & Johnson (JnJ) said on Monday it had temporarily paused its Covid-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the highest-profile efforts to contain the global pandemic.
The participant's illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company's clinical and safety physicians, the company said in a statement.
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. The current case is a pause.
However, J&J's move follows a similar one by AstraZeneca. In September, AstraZeneca paused late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, due to an unexplained illness in a UK study participant.
While trials in the UK, Brazil, South Africa, and India have resumed, the US trial is still 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 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," 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 kicked off a final 60,000-person trial, whose results had been expected by the end of this year or early 2021.
Johnson & Johnson declined to elaborate on the illness due to privacy concerns. It did say that some participants in studies get placebos, and it was not always clear whether a person suffering a serious adverse event in a clinical trial received a placebo or the treatment.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.