The Covaxin coronavirus vaccine, made in India, began its phase three human clinical trial at AIIMS in New Delhi on Thursday with Dr. MV Padma Srivastava, head of the main institute’s Neuroscience Center, and three other volunteers who received the first dose.
AIIMS’s Dr. Srivastava was the first to receive the vaccine, which would be administered to some 15,000 volunteers at the medical institute over the next few days, the news agency reports. PTI.
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, according to the report.
Dr Srivastava said: “Covaxin is the first indigenously developed coronavirus vaccine, and in addition, my institute is participating in the trial. I am honored to be the first volunteer to receive the vaccine. I am happy to be a part of Such a great cause. I’m perfectly fine and working. “
Coronavirus vaccine route
As part of the test application, a 0.5 ml dose would be administered on day 0 and day 28, the report added.
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.
Covaxin injections arrive at Ahmedabad hospital
Earlier on Wednesday, a shipment of Covaxin, one of the coronavirus vaccine candidates, arrived at the Sola civil hospital in Gujarat for phase III clinical trials.
Sola civil hospital in Ahmedabad is one of 130 centers in India where the third phase of Covaxin clinical trials will take place, said HG Koshia, commissioner of the Gujarat Food and Drug Control Administration (FDCA).
‘Covaxin’ is being developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
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.
Meanwhile, India recorded 44,489 fresh Covid-19 infections in a 24-hour span and 524 deaths due to the infection, according to the Union Ministry of Health and Family Welfare on Thursday.
Total cases in India now stand at 92.66,706, including 86,79,138 discharges and 4,52,344 active cases. The accumulated toll of the country has reached 1,35,223.
With contributions from the agency
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