The AIIMS Ethics Committee has approved human clinical trials of the indigenously developed COVID-19 vaccine candidate Covaxin.
The All India Institute of Medical Sciences (AIIMS) Ethics Committee on Saturday approved human clinical trials of the indigenously developed COVID-19 vaccine candidate Covaxin. The trials will be conducted by AIIMS Delhi from Monday on 100 healthy volunteers aged between 18 and 55.
"Today, we got approval from AIIMS Ethics Committee for starting the human clinical trial of the indigenously developed Covaxin. We are launching the enrollment process from Monday. We are going to select healthy participants with no comorbidities and without a history of COVID-19. The age group of the study population is 18 to 55 years. This would be a randomised, double-blind, placebo-controlled clinical trial," Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said.
The volunteers will be kept under observation for a period of nearly 150 days.
Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The Phase 1 clinical trial for Covaxin has been initiated across the country from July 15 onwards, and this is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers across the country.
AIIMS has also set up a dedicated email and phone number for the volunteers to register themselves for this project. The volunteers will have to undergo tests, which include COVID-19 test and also tests for other comorbidities. If found healthy, they will be administered the vaccine.
According to a senior official, recently the ethics committee has given a go-ahead for human trials for the vaccine, and AIIMS will begin registering volunteers as per the procedure.
"After administering the vaccine, we will follow up with the volunteers through phone calls. They will be kept under observation for nearly 150 days," added Rai. Volunteers willing to register for human trials can email at ctaiims.covid19@gmail.com.
On Friday, Haryana Health Minister Anil Vij had said that human trial of a vaccine against novel coronavirus has begun at the Post Graduate Institute of Medical Sciences in Rohtak. "Three subjects have enrolled for the trial and tolerated the vaccine very well. There were no adverse effects," he said.
The SARS-CoV-2 strain was isolated in NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3A (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO), and the Ministry of Health & Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
(With agency inputs)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
 "coronavirus vaccine")
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}
)
){kind=small}
){kind=small}
)
)
)
)
)
){kind=small}
){kind=small}
){kind=small}
){kind=small}
){kind=small}