The Drugs Controller General Of India on Tuesday allowed Serum Institute of India to resume clinical trials of its experimental coronavirus vaccine being developed along with pharmaceutical company AstraZeneca and the Oxford University, PTI reported. The earlier suspension order, stopping new recruitment for the Phase 2 and Phase 3 trials, has been revoked.
On September 12, AstraZeneca had announced that it has resumed the clinical trials of its vaccine in the United Kingdom after confirmation by the Medicines Health Regulatory Authority that it was safe to do so. The late-stage trials of the vaccine, one of the most advanced in development, was put on hold on September 9 after a study participant developed an unexplained illness. The company said it could not disclose further medical information. In India, Drugs Controller General of India VG Somani had asked Serum Institute for details on the suspension of trials overseas and to explain why the trials should not be suspended in the country until patient safety is verified.
The Serum Institute on Tuesday submitted the recommendations of Data and Safety Monitoring Board and requested permission to restart enrolment for the clinical trials. The DCGI has directed the vaccine maker to take extra care during screening, provide additional information and closely monitor participants for adverse events. Serum has also been asked to submit details of medication used in accordance with the protocol for management of adverse events.
According to the drugs regulator order, Serum Institute has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.
“In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019,” the order said. “You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned.”
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 study subjects till the date of the reporting, adding that mild events were resolved on their own.
AstraZeneca is one of nine companies in late-stage Phase 3 trials for their vaccine candidates. Trials of the vaccine, called AZD1222, are currently underway at different stages in Britain, the United States, Brazil, South Africa and India. As many as 17 sites in India are conducting testing for the vaccine. It is being tested on individuals between the ages of 18 and 55. The trials began on August 26.
The vaccine had produced an immune response against the coronavirus and proved to be safe in early-stage clinical trials, according to results published in medical journal The Lancet.
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