Serum Institute of India has received Indian regulatory approval to resume local clinical trials of AstraZeneca's potential COVID-19 vaccine, a reports said on Wednesday (16).
The Drugs Controller General of India (DGCI), however, put in place certain "conditions" such as taking extra care during screening, providing additional information in consent forms and close monitoring for adverse events during follow-up of the study, which have to be "scrupulously" followed by the institute.
SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
According to the order, the institute submitted revised participant information sheets, informed consent forms and additional safety monitoring plan for the trials.
The Pune-based firm also submitted a summary of safety follow-up of seven days post first vaccination, stating that no serious adverse events -- except those stated to have been mild, resolved on their own and did not have any sequela -- were experienced by any of the subjects till the date of the reporting.
The DCGI had directed Serum to suspend any new recruitment in the phase II and III clinical trials 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.
On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine had resumed in the UK after the Medicines Health Regulatory Authority's green signal.
Trials resumed in Brazil and South Africa, too, but remained on hold in the US.
