A clinical trial of the fourth Covid vaccine Novavax, known as Covovax in India, has begun at the civic-run KEM hospital in Parel last week. The trial is being conducted by the Indian Council of Medical Research (ICMR) at 20 hospitals across the country, of which KEM is one of them. Besides KEM, seven more hospitals have been selected to carry out trials in the state.
Covovax is the second vaccine being made by Serum Institute of India (SII). The first was Oxford-AstraZeneca vaccine that was produced in India by SII as Covishield.
Dr. Hemant Deshmukh, dean of KEM hospital, said the ethics committee of the hospital has given a nod to carry out clinical trials of Covovax. Around 80 to 100 volunteers have been selected based on the criteria prepared by the ethics committee, which includes patients who will be tested for Covid before being a part of the trial.
So far, Covovax has shown 100% protection against moderate to severe impact of the virus. Overall, there was a 90.4% efficacy in the phase 3 trial.
“Two days ago, we started the clinical trials of the Covovax that has an efficacy of 90.4% in the phase 3 trial. We have around 80 volunteers for the trial but we cannot comment more,” said Dr Deshmukh.
As per the Clinical Trial Registry issued on June 29, the nation-wide clinical trial will be conducted on 1,600 volunteers across 20 hospitals, which means 80 volunteers from each hospital. Moreover two shots will be administered to volunteers, while the second jab will be given after 22 days. Also, the written consent has been taken from participants.
As reported, SII plans to apply for permission from the Drug Controller and General of India (DCGI) to conduct a clinical trial of the same among children.
