The Drugs Controller General of India (DCGI) gave permission to Pune Serum Institute of India (SII) to resume its phase two and three clinical trials of the Oxford Covid-19 vaccine candidate in the country.
DCGI VG Somani, in a letter to SII, has 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 said as reported by news agency ANI.
The DCGI has also asked SII to submit the details of the medication used as per protocol for the management of the adverse events.
The Pune-based firm has also 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.
The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ”an unexplained illness” in a participant in the study.
AstraZeneca has already resumed trials in the UK for the vaccine.
SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, was granted permission by India’s top drugs regulator in August to conduct a phase 2/3 clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.