The Drugs Controller General of India (DCGI) has given permission to the Pune-based Serum Institute of India (SII) to resume the clinical trial of the Oxford/AstraZeneca COVID-19 vaccine in the country.
The DCGI has revoked its earlier order of suspending recruitment of any new volunteer for the Phase 2/3 clinical trial.
The DCGI has asked SII to submit details of medication used in accordance with the protocol for the management of adverse events.
Besides, the drug regulating body of the country has told the Serum Institute to take extra care during screening, provide additional information in informed consent, and closely monitor participants for any adverse events during follow-up of the study.
Last week, pharma giant AstraZeneca and the University of Oxford resumed the clinical trial of its COVID-19 vaccine AZD 1222 in the UK, following the confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.
The human trials in the UK resumed few days after getting paused after a participant reported illness.
In India, Serum Institute is conducting Phase 2/3 human trials for the COVID-19 vaccine developed by the University of Oxford and AstraZeneca.
Consequently, the DCGI also directed SII to suspend the trial until further notice. The DCGI had issued a show-cause notice to SII on September 9 for not informing it about AstraZeneca pausing clinical trials of the vaccine candidate in other countries. On September 11, the DCGI directed the SII to suspend any new recruitment in Phase 2/3 clinical trials till further orders.
Yesterday, SII submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, to the DCGI, requesting to restart enrolment in the clinical trial.
According to Tuesday's order issued by the DCGI, the DSMB, UK, recommended the investigators to recommence all immunisation in their clinical trials, subject to certain conditions. DSMB, India, has also recommended continuing the study and enrolment of the remaining participants in the clinical trial as per protocol subject to certain conditions.
The SII has submitted a revised participant information sheet, revised informed consent form, and an additional safety monitoring plan for the evolved participants.
The Pune-based firm on Tuesday submitted a summary of safety follow-up of seven days post first vaccination. SII assured that no serious adverse events were experienced by any of the participants until the date of the reporting. The reported adverse events were stated to be mild, resolved on their own, it added.
University of Oxford/AstraZeneca's potential coronavirus vaccine is among the frontrunners in the race towards a safe and effective vaccine that could put a dent in the global pandemic. The company launched its late-stage trials at the end of August. Officials from the World Health Organisation had previously hailed AstraZeneca's vaccine candidate as one of the most promising candidates, which are currently in development.
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