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Human trial of Covaxin begins at Rohtak PGIMS
Covaxin has been developed by the Hyderabad-based pharmaceutical company Bharat Biotech in collaboration with National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR)
Haryana health minister Anil Vij on Friday announced that human trials to fight coronavirus with Covaxin — the country’s foremost vaccine candidate for Covid-19 — have started at the Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.
“Three subjects were enrolled for this purpose today (Friday). All three have tolerated the vaccine very well. There were no adverse effects,” he tweeted.
Covaxin has been developed by the Hyderabad-based pharmaceutical company Bharat Biotech in collaboration with National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR). The Drug Controller General of India (DCGI) earlier approved the biotech company to initiate the phase 1 and 2 human clinical trials.
PGIMS has become the second facility in India after All India Institute of Medical Sciences (AIIMS), Patna, to begin the human trials.
Dr Savita Verma, principal investigator of the trial, said they had administered the first dose of vaccine (0.5ml) to three volunteers on Friday.
“These volunteers were kept under observation for three hours. They tolerated the vaccine very well. Later, the volunteers were sent back home and a team of doctors will now examine their health everyday. PGIMS, along with three other medical institutes, will conduct human trials on 50 volunteers in the first phase. The second phase will commence 14 days later after seeing the result of the vaccine in these volunteers,” she added.
Dr Verma said 17 individuals have undergone rigorous medical scrutiny so far to check whether they have been previously infected with the virus or suffered from any liver, lungs or kidney ailments and any other infectious diseases.
“Three of these volunteers, who were found eligible, were administered the vaccine today and the report of 13 is awaited,” she added.
Co-investigator Dr Ramesh Verma said, “If any of these volunteers experiences adverse effects, Bharat Biotech will compensate them. We urge more volunteers to register themselves for the human trials,” Dr Verma added.
