Therapy Areas: Vaccines
Johnson & Johnson temporarily pauses COVID-19 vaccine trials due to unexplained illness in a participant
13 October 2020 -

US pharmaceutical company Johnson & Johnson (J&J) (NYSE:JNJ) temporarily paused its COVID-19 vaccine candidate clinical trials on 12 October 2020, due to an unexplained illness in a study participant, Reuters news agency reported on Tuesday.

According to a statement by J&J, 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.

J&J stated 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.

According to Reuters, J&J's pause follows a similar one by British pharmaceutical company AstraZeneca Plc (STO:AZN) (LON:AZN), which is September 2020 paused late-stage trials of its experimental COVID-19 vaccine, developed with the University of Oxford, due to an unexplained illness in a UK study participant.

While trials of the AstraZEneca vaccine in the UK, Brazil, South Africa and India have resumed, the US trial is still on hold pending a regulatory review.

J&J had said in September 2020 that its experimental COVID-19 vaccine produced a strong immune response against COVID-19 in an early-to-mid stage clinical trial, following which the company kicked off a final 60,000-person trial, results of which had been expected by the end of 2020 or early 2021.

Reuters added that Johnson & Johnson declined to elaborate about 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.



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