Strange Illness in Participant Halts COVID-19 Vaccine Trials by J&J
On Monday, Johnson & Johnson stated that it had halted (for time being) its COVID-19 vaccine candidate clinical trials. This happened after an unexplained illness occurred in a study participant, delaying one of the biggest profile efforts to curb the global pandemic.
“Such Pauses are Normal”
The illness developed in the participant is being reviewed and studied by an independent data and safety monitoring board along with the clinical and safety physicians of the company, according to the statement.
J&J, on Tuesday morning, stated that such halts are normal in trials of this scale, which can consist of tens of thousands of people. It stated that the “study pause” in providing doses of the vaccine candidate was different from a “regulatory hold” needed by health authorities. The current scenario is a pause.
However, J&J’s move is similar to one by AstraZeneca Plc. In September, AstraZeneca also put a hold on late-stage trials of its experimental coronavirus vaccine, made with the support of University of Oxford, due to an unexplained illness in a UK study participant.
Trials in the UK, South Africa, Brazil, and India are again on track. However, the U.S. trial is still paused due to a pending regulatory review.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, stated via an email that “Everybody is on the alert because of what happened with AstraZeneca.” The professor also added that it could take a week to accumulate information.
“It would have to be a serious adverse event. If it was 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,” he said.
Last month, J&J stated that its experimental COVID-19 vaccine generated a strong immune response in defense with the novel coronavirus in an early-to-mid stage clinical trial. After which the company started a final 60,000-person trial, whose results had been anticipated by the end of this year or early 2021.
Johnson & Johnson refused to explain the illness because of privacy reasons. However, the company said that some participants in studies receive placebos. J&J also said that it was not always evident whether a person suffering a serious adverse event during a clinical trial got a placebo or real treatment.