The Lokmanya Tilak General Hospital, also known as Sion Hospital, will soon start phase-3 clinical trials of India’s indigenous Covid-19 vaccine—COVAXINTM. As many as 1,000 volunteers between the age of 18 and 60 years will participate in the trial.
Currently, King Edward Memorial (KEM) and BYL Nair hospitals are running clinical trials on the Oxford-AstraZeneca Covid-19 vaccine— Covishield.
The Indian Council of Medical Research (ICMR) selected Sion Hospital for the trial of COVAXINTM, a proposal for which has been submitted to the ethics committee of the hospital for the final approval.
Dr NT Awad, head of pulmonary medicine at the hospital, said, “We have been selected for the third phase of the national trial. We are really proud that our hospital has been selected for the first indigenous Covid-19 vaccine. The volunteers will be followed up for 12 months as per rules.”
As per the official website of Bharat Biotech, the vaccine is developed in a BSL-3 (Bio-Safety Level 3) high-containment facility. The vaccine received Drugs Controller General of India (DCGI) approval for phase I and II human clinical trials, which commenced across India in July.
“After successful completion of the interim analysis from phase 1 and 2 clinical trials of COVAXINTM, Bharat Biotech received DCGI approval for phase-3 clinical trials in 26,000 participants in over 25 centres across India,” read the website.
The trial will be conducted on 1,000 volunteers, of which 20% will have co-morbidities, while 5% will comprise health workers. “The remaining 75% will be healthy volunteers. All volunteers will have to undergo RT-PCR and antibody tests before being qualified for the trial,” said Dr Awad. The third phase will have two stages. After 28 days of the first vaccination, the volunteers will be given the second vial. “Every month, we will follow up on them. If any of them develop any symptoms of Covid-19, they will be immediately tested for the virus,” added Dr Awad.
Nair Hospital gives vaccine to another 48 volunteers
As HT reported earlier, Nair Hospital has sought ICMR approval to conduct trials of Covishield vaccine on additional volunteers. After the hospital was granted permission, another 48 volunteers have been given the vaccine till November 1.
“So far, 148 people have participated in the trial. Earlier, it was 100 volunteers, but later, after getting approval of ICMR, we added 48 more individuals,” said Suresh Kakani, additional municipal commissioner, Brihanmumbai Municipal Corporation.
