Mumbai's Sion Hospital soon to begin anti COVID vaccine phase 3 trial
By MYBRANDBOOK
Sion Hospital will soon commence phase 3 clinical trial of India’s indigenous anti Covid-19 vaccine-COVAXINTM. As many as 1,000 volunteers between the age of 18 and 60 years will participate in the trial.
Currently 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 which has been submitted to the ethics committee of the hospital for 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 the official website of Bharat Biotech reads, the vaccine is developed in a BSL-3 (Biosafety Level 3) high-containment facility. Drugs Controller General of India (DCGI) has given their approval to the vaccine and also to the 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 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.
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