In its communication, the DCGI has taught the company to take extra care throughout screening, supplying additional information in informed consent and close monitoring for adverse events during a follow-up of this analysis.
The SII has also been asked to submit to the DCGI’s office information of drug used in accordance with the protocol for the management of adverse events.This past Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their vaccine candidate had resumed in the U.K. after the Medicines Health Regulatory Authority verified the trials were safe. SII had previously this week submitted the recommendations of the Data and Safety Monitoring Board (DSMB), U.K. and DSMB, India, and asked permission to resume enrolment in the clinical trial.
It added that Maharashtra, Karnataka, Andhra Pradesh, Uttar Pradesh, Tamil Nadu write close to 60 percent of the active cases and 70% of the entire active cases are found in the nine most affected States/UTs.
“82,961 COVID patients were treated and discharged from home/facility hospitals and isolation in the last 24 hours and with this the total recovered instances stand at 39,42,360. In the previous 24 hours, Maharashtra (19,423) donated 23.41% of the new recoveries whereas the States of Andhra Pradesh (9628), Karnataka (7406), Uttar Pradesh (6680) and Tamil Nadu (5735) contributed 35.5percent of the new recoveries. Nearly 59 percent of their new recoveries came from these five States. 27 States/UTs are reporting a recovery rate over 70%. There are 9,95,933 active cases in the nation now,” the release stated.
AstraZeneca has resumed trials from the UK for the vaccine.
The DCGI had on September 11 led Serum Institute of India to suspend any fresh recruitment in the stage three and two clinical trial of this Oxford COVID-19 vaccine candidate till further orders at the backdrop of pharma giant AstraZeneca tripping the clinical trials in different states because of”an unexplained disease” in a participant in the analysis.
SII, that has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, was granted permission by India’s top drugs regulator in August to conduct a stage 2/3 clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) in different clinical trial sites in the country to determine its safety and immunogenicity.