Johnson & Johnson suspends COVID-19 vaccine clinical trials as participant develops unexplained illness

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The company said the participant’s illness is being reviewed and evaluated by a monitoring board as well as its internal clinical and safety physicians

US pharma major Johnson & Johnson on Tuesday said that that it temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant.

Adverse events – illnesses, accidents and the like - even those that are serious, are an expected part of any clinical study, especially large studies, the company said in a statement.

“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent data safety monitoring board (DSMB) as well as our internal clinical and safety physicians,” Johnson & Johnson said.

The company said that based on the strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines.

It further said that these measures ensure its studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.

The US company said that there is no greater priority than the safety and well-being of the people it served every day around the world.

“We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards and our own high ethical and scientific principles,” Johnson & Johnson said.

The US firm said that the participant’s privacy must be respected and it is in the process of learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.

SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo, said Johnson & Johnson.

It may be recalled that British firm AstraZeneca had suspended its COVID-19 vaccine’s clinical trials last month. The British group paused late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, due to an unexplained illness in a British study participant.

As a result, in India also, where Pune-based Serum Institute of India is manufacturing AstraZeneca’s COVID-19 vaccine, the trials were suspended following a government order.

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