New Delhi: Drugs Controller General of India (DCGI) Dr. VG Somani has given the go-ahead to the Serum Institute of India to continue the clinical trial of the Oxford COVID-19 vaccine candidate in the nation while revoking its prior order of suspending any new enrollment for stage two and three trial.
The DCGI has, however, put certain conditions like taking additional care during screening, giving extra data in informed consent, and close monitoring for unfavorable events during follow-up of the investigation which must be "scrupulously" followed by the Serum Institute of India (SII). SII will also have to submit to the DCGI's office details of drugs used in accordance with the protocols for the management of adverse events.
On September 11, the DCGI had directed the Serum Institute of India to suspend any new enrollment in stage two and three clinical trials of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca delaying the clinical trials in different nations due to ''an unexplained illness'' in a member in the study.
British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford on September 13 said that clinical trials for their Covid 19 vaccine have continued in the UK after the Medicines Health Regulatory Authority's (MHRA) affirmed that the trials were safe.
SII has partnered with AstraZeneca for manufacturing the vaccine candidate to COVID-19. On September 15, SII submitted the recommendation of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested authorization to restart enrolment in the clinical trial.
As per Tuesday's order issued by DCGI, the DSMB, UK, suggested that the investigation recommence all immunization in their clinical trials subject to specific conditions.
DSMB, India, additionally has recommended to proceed with the study and enroll the rest of the participants in the clinical trial according to protocol subject to certain conditions.