Johnson & Johnson COVID vaccine trials paused after unexplained illness in volunteer!
Galatta | Oct 13, 2020, 04:18 pm
The entire world is returning to a semblance of normalcy however this is not because the COVID-19 Novel Corona Virus Pandemic has been eradicated but more so because the economy cannot withstand anymore lockdowns! People are being advised to go about their day-to-day work with all safety precautions mandated by healthcare professionals. Though Russia announced the registering of the world's first COVID-19 vaccine Sputnik V, it has not been accepted entirely by the medical fraternity as the vaccine did not go through all the required clinical trials. Meanwhile, there are about 15 other vaccine candidates which are in the last stage of trials and are expected to be ready for manufacturing soon. Now, there has been a setback in the clinical trials of the vaccine candidate being developed by Johnson & Johnson!
A statement from the company revealed that it has temporarily halted its COVID-19 vaccine trial after one of the volunteers participating in them, developed an unexplained illness! The statement read, "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." This means that the enrollment for participating in the 60,000 patient clinical trials has also been closed till the independent patient safety committee is convened. Johnson & Johnson also added that Serious Adverse Events (SAEs) like accidents or illnesses are "an expected part of any clinical study, especially large studies". As per company guidelines, the clinical trials will be paused till it is determined as to whether the SAEs caused was due to the vaccine candidate, before resuming the trials!
The ENSEMBLE Phase 3 trials for J&J's vaccine candidate began in late September with the aim of enrolling up to 60,000 volunteers across more than 200 sites in the US and other parts of the world. This vaccine candidate is being jointly developed by J&J and the US National Institute of Health (NIH), which is providing the funding. The pre-clinical testing of this vaccine candidate on Rhesus Macaque monkeys showed it to provide complete or near-complete protection against the virus infection in the lungs and nose. J&J received around 1.45 billion dollars as funding from the United States for this project, under the Operation Warp Speed. The start of these clinical trials made J&J the fourth US company and tenth overall in the world to do so. Earlier, AstraZeneca too faced a similar issue when they had to stop their clinical trials following one of their volunteers developing some unexplained complications. Trials have since resumed in Japan and other places but not yet in the USA.