In a major development, AIIMS Delhi will begin human trials of India’s first indigenous Covid-19 vaccine, Covaxin, from next week on 100 healthy volunteers aged between 18 and 55.
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).
According to Bharat Biotech, 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.
Sanjay Rai, Professor of Community Medicine and Principal Investigator of Covid-19 vaccine trial at AIIMS, said, “We will begin human trials of India’s first indigenous vaccine, Covaxin, on 100 healthy volunteers aged between 18 and 55 years. We will ensure that none of the volunteers have any comorbidities. AIIMS will conduct trials on 100 volunteers out of a total of 375 persons.”
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 firstname.lastname@example.org.
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.