- The volunteer’s ailment is under evaluation by an independent data and safety monitoring board.
- J&J followed an indistinguishable step like AstraZeneca.
- During the analysis of clinical trials, some volunteers get placebos.
THD NewsDesk, Mumbai: On Monday, Johnson & Johnson stated that it had briefly paused its COVID-19 vaccines candidate clinical trials because of a baffling illness in a volunteer. Due to this, one of the most substantial efforts to fight the global pandemic is being delayed.
The company averred in a statement, the volunteer’s ailment is under evaluation by an independent data and safety monitoring board and the company’s clinical and safety physicians.
On Tuesday, J&J informed about quarterly financial results, and such pauses are standard in trials, which include a large number of volunteers. They also stated, “study pause” in offering doses of the vaccine candidate was distinct from “regulatory hold” needed by health authorities. The current case is at a halt.
J&J followed an indistinguishable step like AstraZeneca. In September, AstraZeneca ceased its clinical trials of the coronavirus vaccine, developed by the University Of Oxford. The UK’s clinical trials underwent a similar situation of unexplained illness in a study volunteer, which led the clinical trials to a standstill.
India, SouthAfrica, UK, and Brazil recommenced their trials. The US is waiting for a regulatory review to resume.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, stated in an email that “Everybody is on the alert because of what happened with AstraZeneca.” He added that it could take a week to collect all the data.
He further added, “It would have to be a serious adverse event. If it were 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.”
Last Month, J&J said it’s experimental of COVID-19 manifested a vigorous immune response against the coronavirus in an early to mid-stage clinical trial. Subsequently, the company will reveal the results of a final 60,000 volunteer trials, either by the year-end or early 2021.
Johnson and Johnson dismissed to explain the illness due to privacy reasons. During the clinical trial analysis, some volunteers get placebos; it is obscure that either the person suffering from a grave clinical trial received a placebo or the treatment.
Source- Times Of India