Human trials of Covaxin, the first indigenous vaccine against the coronavirus, will soon begin at All India Institute of Medical Sciences in Delhi Director Randeep Guleria said, NDTV reported. Researchers would need at least three months to get the first set of data. The ethics committee of the AIIMS in Delhi on Saturday gave the institute the approval to start the human trial, following which the medical institute began enrolling volunteers on Monday.
Human trials of the vaccine began at the Redkar Hospital in Goa, Chief Minister Pramod Sawant announced on Twitter.
The news came as India reported its biggest single-day jump in coronavirus infections and deaths. With 40,425 new cases, India’s total count went up to 11,18,043. The toll rose by 681 to 27,497.
The first phase of the trials will include 375 volunteers between the age group 18 and 55 and without a history of coronavirus and other co-morbid health conditions, while the second phase would involve 750 individuals in the 12-65 age group and the third phase would have a larger sample size. They would be injected with inactivated Sars-CoV-2 so that their bodies produce antibodies to fight Covid-19.
“It [starting trials] is heartening because it’s an indigenous vaccine; making a new vaccine is an achievement,” Guleria said. “Even if a vaccine is first developed somewhere else in the world, India will be mass producing it. We are good at it.”
Guleria said that it would be difficult to predict when the vaccine would be ready and dismissed reports of community transmission in India. He claimed that there was only local transmission in some places. So far, officials in Kerala and West Bengal have admitted that there is community transmission in some parts of their states. Those in Delhi, meanwhile, have said that the source of many infections is not known, which could mean that there is either local or community transmission in the Capital.
Sanjay Rai, professor at the Centre for Community Medicine at AIIMS and the doctor who would be overseeing the trials, said men and women would be recruited but the women cannot be pregnant. Rai said their priority was to ensure safety and added that the virus’ mutation would decide the effectiveness of the vaccine. Healthcare workers and people who belong to vulnerable groups would be on the priority list for the vaccine, he added.
AIIMS Delhi is among the 12 facilities chosen by the Indian Council for Medical Research for the first two phases of Covaxin trials. Covaxin was the first indigenous vaccine to get permission for human trials by the Drug Controller General of India, on June 29. It has been jointly developed by a Hyderabad-based private firm Bharat Biotech, the Indian Council for Medical Research and the National Institute of Virology.
Last month, ICMR had directed trial sites for Covaxin to fast-track necessary approvals and said that it planned to launch the vaccine for public use by August 15. The top medical body’s deadline was called unrealistic and unscientific by health experts. ICMR had defended its deadline, saying that it was in accordance with global norms to fast-track vaccine development.
India’s second vaccine candidate – Gujarat-based pharmaceutical giant Zydus Cadila’s ZyCoV – also entered the human trials stage earlier this week. The clinical trials of ZyCoV will be conducted across multiple sites in India with over 1,000 subjects.