Serum Institute Gets DCGI Nod To Resume Clinical Trial Of Oxford COVID-19 Vaccine
Serum Institute of India has been given a clear chit by the Drugs Controller General of India to restart clinical trials of the vaccine candidate.
The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by Serum Institute of India (SII).
The Serum Institute is working with 5 international companies to develop the coronavirus vaccine. These companies also include AstraZeneca and Novavax.
There are in total 17 trial sites, out of which four are in Pune, of which three had been involved in administering the Covishield vaccine dose as the initial part of phase II clinical study.
Meanwhile, British-Swedish biopharmaceutical giant Astra Zeneca and the University of Oxford said clinical trials for their vaccine candidate had resumed in the U.K. after the Medicines Health Regulatory Authority confirmed that the trials were safe.
India reported more than 90,000 cases of coronavirus in the last 24 hours. Also, 82,961 COVID patients were cured and discharged from home/facility isolation and hospitals in the last 24 hours and with this the total recovered cases stand at 39,42,360. In the last 24 hours.