Indian firm Bharat Biotech has initiated the Phase III human clinical trial of the anti-Covid-19 vaccine candidate, Covaxin, at the AIIMS.
The company is developing Covaxin in partnership with the Indian Council of Medical Research (ICMR).
Bharat Biotech received approval to conduct the clinical trials of Covaxin from the Drugs Controller General of India (DCGI).
The randomised, double-blind, placebo-controlled, multi-centre trial will enrol around 28,500 adult participants in 25 sites across ten states in the country, PTI reported.
The trial participants will receive a 0.5ml intramuscular injection of the vaccine candidate on day 0 and day 28.
Initially, AIIMS Neurosciences Centre chief Dr M V Padma Srivastava, as well as three other volunteers received the first dose of Covaxin.
They were observed for two hours and will be followed up for the next few days.
In the coming few days, approximately 15,000 volunteers at the AIIMS will receive the vaccine.
Srivastava told the news agency: “Covaxin is the first indigenously-developed anti-coronavirus vaccine and on top of that, my institute is participating in the trial.
“I am honoured to be the first volunteer to receive the shot. I am happy to be a part of such a great cause. I am perfectly fine and I’m working.”
The latest development is backed by the safety and immunogenicity data from Phase I and II trials submitted to the central drug regulator.
While seeking approval for the Phase III trial, Bharat Biotech said that the vaccine was well-tolerated in all dose groups and no serious adverse events were observed in the previous trials.
Apart from Covaxin, four other vaccines are being trialled in India.
In August, Bharat Biotech reported that Covaxin demonstrated an encouraging safety profile in a Phase I trial.