Serum Institute of India gets DCGI permission to restart phase 2, 3 trials of coronavirus COVID-19 vaccine
The Serum Institute of India (SII) is all set to restart its phase two and three clinical trials for the COVID-19 vaccine after getting the nod from the Drugs Controller General of India (DCGI).
According to ANI, the SII had sought permission from the DGCI to restart the re-enrollment procedure for COVID-19 vaccine which is being developed by AstraZeneca and Oxford University following the Data Safety Monitoring Board (DSMB) recommendations.
“You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the DSMB, India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up,” the DCGI said in its letter to the Serum Institute.
On September 8, AstraZeneca had announced that it “voluntarily paused” the phase 3 clinical human trials of its vaccine candidate ‘Covishield’ after one of the volunteers got ill.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow a review of safety data by an independent committee,” the pharma major had said in a statement.
The vaccine trial was put on hold in the US, Brazil and the United Kingdom but the trials have now resumed in the UK.
According to reports, the DSMB has allowed Serum Institute to restart the vaccine trials on three conditions: first, all relevant participant information must be recorded. Second, the additional safety monitory plans must be devised by SII for volunteers participating in trials and lastly the contact numbers of all participants must be recorded in case of an emergency.