(Reuters) – Johnson & Johnson JNJ.N On Monday, it said it had temporarily halted its COVID-19 vaccine candidate clinical trials due to an unexplained disease in a study participant, delaying one of the highest-profile efforts to include the global epidemic.
The participant’s disease is reviewed and evaluated by an independent data and safety monitoring board, as well as by the company’s clinical and safety physicians, the company said here in a statement.
J&J, which reported quarterly financial results on Tuesday morning, said such stagnation is common in large trials that may involve tens of thousands of people. It stated that the “study stagnation” in giving the vaccine candidate dose was different from the “regulatory hold” required by health officials. The present case is a break.
However, the move to Jammu and Kashmir is similar to that by AstraZeneca plc. In September, AstraZeneca AZN.L Developed with the University of Oxford, due to an unexplained disease in a UK study participant, stopped the end-stage trials of his experimental coronavirus vaccine.
Although tests have resumed in Britain, Brazil, South Africa and India, the US trial is still pending a regulatory review.
A professor of infectious diseases at Vanderbilt University School of Medicine, Drs. William Scheffner said by email that “everyone is on alert with what happened to AstraZeneca,” adding that it could take a week to gather information.
“This will 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. It is likely to be a neurological event, ”he said.
Last month, J&J stated that its experimental COVID-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid-stage clinical trial, after which the company closed the final 60,000-person trial , The results of which were expected later this year or early 2021.
Johnson & Johnson elaborated on the illness due to privacy concerns. It stated that some participants in the study received placibos, and it was not always clear whether a person suffering a serious adverse event in the clinical trial received the placebo or treatment.
Earlier in the day, State News reported the researchers citing a document sent to outside researchers, stating that the “stagnation rule” had been met, to be used to recruit patients to the study The Vala online system was shut down and a data and security monitoring board would be called.
Reporting by Ayanti Berra in Bengaluru, Dina Beazley in Los Angeles and Peter Henderson in Oakland; Editing by Rashmi Aich