(Reuters) – Johnson and Johnson JNJ.N said on Monday that it had temporarily suspended clinical trials of a candidate for the COVID-19 vaccine due to unexplained disease in a study participant, postponing one of the most important efforts to curb the global pandemic.
J&J, which reported quarterly financial results on Tuesday morning, said such breaks were normal in large trials, which could involve tens of thousands of people. It states that the “pause in the study” when giving doses to the vaccine candidate is different from the “regulatory detention” required by the health authorities. The current case is a pause.
However, J & J’s move is similar to that of AstraZeneca Plc. In September, AstraZeneca AZN.L paused the late stages of his experimental coronavirus vaccine, developed with the University of Oxford, due to an unexplained illness of a participant in a British study.
While trials in the United Kingdom, Brazil, South Africa and India have resumed, trials in the United States are still pending regulatory scrutiny.
Dr William Schaffner, a professor of infectious diseases at Vanderbilt University School of Medicine, said in an email that “Everyone is on the lookout for what happened to AstraZeneca”, adding that it could take a week to gather information.
“It simply came to our notice then. If it was something like prostate cancer, uncontrolled diabetes or a heart attack – they would not stop it for any of these reasons. This is likely to be a neurological event, “he said.
Last month, J&J said its experimental vaccine, COVID-19, elicited a strong immune response against the new coronavirus in an early-to-intermediate clinical trial, after which the company launched a final study of 60,000 people expected later this year or early. of 2021.
Johnson & Johnson declined to give details about the disease due to privacy concerns. He says some study participants received a placebo, and it was not always clear whether a person suffering from a serious adverse event in a clinical trial had received a placebo or treatment.
Stat News reported here about the break earlier in the day, citing a document sent to outside researchers stating that a “pause rule” had been followed, the online system used to enroll patients in the study was closed and the data and safety board will be convened.
Report by Ayanti Bera in Bengaluru, Deena Beasley from Los Angeles and Peter Henderson from Oakland; Edited by Rashmi Eich