Johnson & Johnson, a US-based giant pharmaceutical company that recently announced its development on the COVID-19 vaccine has temporarily paused its vaccine trial after a participant became ill.
The company informed about 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”
Further, in its statement, it stated, “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”
Adverse Effects Not Uncommon In Clinical Trials
They respect the ill participant’s privacy, the company said in a statement, and also stated that that they are working more on it to learn about this participant’s illness, and it’s important to have all the facts before they share additional information. Adverse and serious 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.
As many trials are placebo-controlled further, it is not always immediately apparent whether a participant received a study treatment or a placebo.
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2nd Vaccine Trial To Be Paused
According to a report the vaccine is being developed by the company’s Janssen arm. However, the company did not mention what the illness was. The 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.
In September, Johnson’s Phase 3 trial was started and is one of the six COVID-19 vaccines being tested in the US. One of four is the most advanced and is in the 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
Last month, the AstraZeneca’s vaccine trial was paused because of a neurological complication in a volunteer in the UK. While the trial resumed in the UK and other countries but it remains paused in the US as it is being probed by the Food and Drug Administration investigators.
A spokesperson for AstraZeneca, a frontrunner in the race for a COVID -19 vaccines said, “standard review process triggered a pause to vaccination to allow a 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.”