New Delhi: The phase three human clinical trial of Covaxin, a candidate for the indigenously developed coronavirus vaccine, began at AIIMS here Thursday with Dr. MV Padma Srivastava, head of the main institute’s Neuroscience Center, and three others. volunteers who received the first dose.
‘Covaxin’ is being developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
Dr. Srivastava was the first to receive the vaccine, which would be administered to some 15,000 volunteers at AIIMS over the next few days, the sources said.
The first dose of 0.5 ml intramuscular injection was administered to four volunteers. They were under observation for two hours and will be monitored for the next few days, a source said.
When contacted, Dr. Srivastava said, “Covaxin is the first locally developed coronavirus vaccine and on top of that, my institute is participating in the trial. I am honored to be the first volunteer to receive the vaccine. I am happy. to be part of such a great cause. I’m perfectly fine and working. ” As part of the test application, a 0.5 ml dose would be administered on day 0 and day 28, the sources said.
The phase three, multicenter, randomized, double-blind, placebo-controlled trial would involve about 28,500 subjects 18 years of age and older. It would take place at about 25 sites in 10 states. Testing has already started on some sites.
Bharat Biotech received permission to conduct phase 3 human clinical trials of Covaxin from the Controller General of Medicines of India (DCGI). Safety and immunogenicity data from phase one and phase two trials were submitted to the central drug regulator. The Hyderabad-based company, in requesting the phase three trial, stated that the vaccine was well tolerated in all dose groups and no serious adverse events have been reported.
The most common adverse event was pain at the injection site, which resolved temporarily, the source said.
In addition, Covaxin, four other vaccines are in different phases of clinical trial in India with the Serum Institute of India conducting the phase three trial of the Oxford-Astrazeneca COVID-19 vaccine, while the vaccine developed by Zydus Cadila has completed phase two clinical. trial in the country.
Dr Reddy’s Laboratories will soon begin combined phase two and three clinical trials of the Russian COVID-19 Sputnik V vaccine in India. Additionally, Biological E. Ltd has begun the first phases 1 and 2 of human trials of its COVID-19 vaccine candidate, officials said last week.
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