India’s most promising vaccine for the novel coronavirus which is currently under development at the Serum Institute of India has been asked to put on hold following issues with patient safety after the test jab, ANI reported.
The DGCI of India – India’s drug regulator – has asked the world’s biggest vaccine maker by volume to ramp up its safety monitoring on patient subjects who have already been injected with the experimental vaccine developed by the Oxford University and AstraZeneca.
The ongoing phase 2 and phase 3 clinical trial must be stopped DGCI Dr. VG Somani said. India’s drug regulator earlier issued a show-cause notice to the pharma giant for not stopping the trial following the overseas suspension of the trial by Astra.
“We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on the same,” the institute wrote in a Twitter statement on Sep 10.
The Serum vaccine being essentially the same Oxford x Astra version was also halted by the institute after the complication arose in one of the patients.
As per the report, DGCI has also demanded a detailed report on the reasons why Astra Zeneca suspended the vaccine trial in the key overseas market.
It must be noted, the surfacing of unexplained illnesses, though not very common in vaccine trials, it is not unexpected as well. Experts have opined, halting a vaccine trial midway because of an unexpected side-effect does not mean the vaccine is not safe.
Rather, it indicates, the makers are undergoing a robust process in the clinical trial.
“These sorts of things happen occasionally in other clinical trials too. We just don’t hear about it,” says Nigel William Crawford (Associate Professor, Murdoch Children’s Research Institute) and Jim Buttery ( Professor of Paediatric Epidemiology, Monash University) writing in The Conversation.
“There’s perhaps never been so much attention on a single clinical trial as there is on the trial of this and other potential COVID-19 vaccines.”