COVID-19 vaccine: Serum Institute gets nod to resume trial in India
DCGI gave nod to Pune based Serum Institute of India (SII) to resume its phase two and three clinical trials of the Oxford COVID-19 vaccine candidate in India
The Drugs Controller General of India (DCGI) gave nod to Pune based Serum Institute of India (SII) to resume its phase two and three clinical trials of the Oxford COVID-19 vaccine candidate in India.
The DCGI, however, put definite conditions like taking extra care during screening, giving additional information in consent and close monitoring for adverse actions during follow-up of the study which have to be ‘scrupulously’ followed by Serum.
The letter as reported by ANI reads, "You (SII) may recommence the clinical trial dated August 2, 2020, as recommended by the Data Safety Monitoring Board (DSMB), India as per already approved protocol and the provisions laid down under New Drugs and Clinical Trials Rules, 2019 subject to the conditions mentioned which are to be scrupulously followed such as extra care during screening, additional information in the informed consent and close monitoring for similar events during the study follow-up.”
Serum has also been asked to submit to the DCGI's office details of medication used in agreement with the protocol for management. The DCGI in last week ordered Serum Institute of India to suspend any new recruitment in phase two and three clinical trial of the Oxford vaccine candidate till further orders in the wake of AstraZeneca halting the clinical trials in other nations because of "an unexplained illness" in a participant in the study.
On Saturday, British-Swedish pharma company AstraZeneca and the University of Oxford said clinical trials for their COVID-19 vaccine have restarted in the UK after the Medicines Health Regulatory Authority's (MHRA) cleared that the trials were safe.