Serum Institute of India (SII) on September 15 received the Drugs Controller General of India (DCGI) nod to resume clinical trial of the Oxford AstraZeneca COVID-19 vaccine candidate in India. The earlier order suspending new recruitment for phase 2 and 3 trial was revoked.
The DCGI had on September 11 directed SII to suspend new recruitment in phase two and three clinical trials of the Oxford COVID-19 vaccine candidate after pharma giant AstraZeneca paused the clinical trials in other countries because of ”an unexplained illness” in a participant in the study.
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AstraZeneca, in a statement on September 8, had said that the COVID-19 vaccine candidate, being developed by AstraZeneca and the University of Oxford, have been put on temporary hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
The trials were resumed on September 12 after the Medicines Health Regulatory Authority’s (MHRA) confirmed that the trials were safe.
However, as per a Reuters report, the vaccine trial remains on hold in the United States pending a US investigation into a serious side effect in Britain.
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While allowing SII to resume trials, the DCGI has put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which has to be “scrupulously” followed by SII.
SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for the management of adverse events.
Also read: AstraZeneca COVID-19 vaccine trial in US on hold until at least midweek: Sources
SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on September 15 submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial.
According to the order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions.
Also Read: WHO praises AstraZeneca COVID-19 vaccine trial pause
According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants.
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, news agency PTI reported.
“In view of the above, I Dr VG 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. 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 order said.
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