On Monday (US Time), Johnson & Johnson, in a statement, confirmed that it had stopped the clinical trials for the experimental one-shot Covid-19 vaccine as a study volunteer got an ‘unexplained illness’. J&J was in the third phase of the trial. The J&J vaccine candidate JNJ-78436735, developed by Janssen Pharmaceutical Companies, had entered phase 3 trials in September.
The aim was to enrol around 60,000 people in the US and other countries for testing the vaccine. J&J is developing the vaccine in association with Beth Israel Deaconess Medical Center in Boston.
In the press release, the company said, “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.” It did not release more information on the illness, stating the privacy of the subject.
It further added,” Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians. The illness and side effects are considered to be a part of any clinical trial. There are guidelines that the company has to follow to monitor such incidents.
The company said the guidelines “ensure our studies may be paused if an unexpected serious adverse event 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.” It is a regulatory hold that any drug company has to follow in case of any incident.
The vaccine candidate being developed by Johnson and Johnson is one of the most advanced Covid-19 shots. The closest competitors for J&J are AstraZeneca, Moderna Inc., and Pfizer Inc. As per the company officials, the results of phase 3 trials will be available by the end of 2020 or in the early months of 2021. Based on the results, the vaccine may get a green signal from the authorities in 2021.
The side effects during clinical trials
During any clinical trial, side effects from the drug or the vaccine are common. Sometimes, the side effects do not have any link to the drug or the vaccine. However, if the independent safety experts find a link, the experimental vaccine may be derailed for safety reasons. J&J said they had paused the trial to access the illness occurred in the subject and to find if there is any link between the vaccine and the illness.
The similar case with AstraZeneca’s trials
In September, AstraZeneca, one of the leading drug companies in developing the Covid-19 vaccine, paused its last-stage trials for the coronavirus vaccine. The University of Oxford is developing it, with India’s Serum Institute Pune roped in as the leading manufacturer. The reason stated in the company’s statement was an unexplained illness in a study participant from the UK. As per the reports, the trials in the UK, Brazil, South Africa, and India have resumed while in the US, they are still under review by the regulatory authorities.