Johnson & Johnson pauses COVID-19 vaccine trial after participant falls ill

Johnson & Johnson temporarily pauses its COVID-19 vaccine trial after a participant became unwell in keeping with the pre-specified guidelines of the company.

US pharmaceutical giant Johnson & Johnson announced that it has temporarily paused its COVID-19 vaccine trial after a participant became unwell. The company communicated this via a statement saying, "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. The patient's condition was being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as internal clinical and safety physicians, it added.

"Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have pre-specified guidelines. These ensure our 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 company statement further said.

Adverse effects not uncommon in clinical trials

In the statement, the company further said that they respect the unwell participant's privacy. They also stated that they are learning more about this participant's illness, and it's important to have all the facts before they share additional information. Serious adverse events are not uncommon in clinical trials, and the number of serious adverse events 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.

2^nd vaccine trial to be paused

The vaccine is being developed by the company's Janssen arm, CNN said in a news report. The company, however, did not mention what the illness was. Trials are stopped when they pop up while doctors check to see if the illness can be linked to the vaccine or is a coincidence. Johnson's Phase 3 trial started in September and it is one of the six coronavirus vaccines being tested in the US, and one of four in the most advanced, Phase 3 stage. This is the second Phase 3 coronavirus vaccine trial to be paused in the US.

AstraZeneca's vaccine trial remains halted in the US

AstraZeneca's vaccine trial was paused last month because of a neurological complication in a volunteer in the UK. While the trial resumed in the UK and in other countries, it remains halted in the US while it is being probed by the Food and Drug Administration investigators. A spokesperson for AstraZeneca, a frontrunner in the race for a COVID -19 vaccine, said earlier in September that the company's "standard review process triggered a pause to vaccination to allow review of safety data." In a follow up statement, AstraZeneca had said that it initiated the study hold. According to a new report of that time, the nature of the adverse reaction and when it happened were not immediately known. However, the report said that the participant is expected to recover. The spokesperson of the company described the pause as "a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

(With inputs from IANS)