New Delhi (NVI): The Drugs Controller General of India (DCGI) gave permission to Pune-based Serum Institute of India (SII) to resume its phase two and three clinical trials for the Oxford COVID-19 vaccine in the country.
This development comes after the pharmaceutical company submitted the recommendations of the Data Safety Monitoring Board (DSMB), UK and DSMB India and requested permission to restart enrolment in the subject clinical trial.
In a letter to SII, DCGI VG Somani, said that the institute’s reply has been carefully examined as also the recommendations of the DSMB in India and in UK.
“You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the Data Safety Monitoring Board (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 letter read.
The DCGI has also asked institute to submit the details of the medication used as per protocol for the management of the adverse events.
In addition to this, Pune-based firm submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale.
AstraZeneca, had earlier paused the ongoing trial of COVID-19 vaccine as a volunteer had developed an unexplained illness.
Reportedly, the vaccine trial was put on hold in the US, Brazil and the United Kingdom but the trials have now resumed in the UK.
On September 11, the DCGI directed Serum Institute to suspend any new recruitment in the phase 2 and 3 clinical trial of the Oxford COVID-19 vaccine candidate till further order.
Earlier in August, the Serum Institute of India, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, was granted permission by India’s top drugs regulator to conduct a phase 2 and 3 clinical trial of COVID-19 vaccine at various clinical trial sites in India to determine its safety and immune response.