Human dosing of Bharat Biotech International Ltd’s vaccine candidate ‘covaxin’ against the novel coronavirus started on Wednesday, with the vaccine being given to participants at All India Institute of Medical Sciences, Patna and Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS) at Rohtak in Haryana, a spokesperson for the company said in a statement late Friday.
“India’s First Indigenous Covid19 Vaccine Covaxin initiated phase-1 clinical trials across the country on 15th July 2020. This is a randomized, double-blind, placebo-controlled clinical trial in 375 volunteers in India,” a spokesperson for Bharat Biotech said in a statement.
AIIMS Patna was the first institute to start the trial on Wednesday and has so far vaccinated around nine people with a smaller dose to check for safety, two sources said, on condition of anonymity. After two weeks, if the vaccine is found to be safe it will be given to more people, the sources said.
Earlier today, Haryana’s health minister Anil Vij tweeted that human trial with Bharat Biotech’s coronavirus vaccine ‘Covaxin’ started at PGIMS Rohtak today.
“Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse efforts,” Vij tweeted.
PGIMS and AIIMS Patna are among the 12 institutes that have been chosen for the 1,125-participant trial of the vaccine candidate, which is jointly developed by Bharat Biotech and Indian Council of Medical Research’s National Institute of Virology in Pune. ICMR has refused to comment on the start of clinical trials.
As per the government’s clinical trial registry, some of the institutes are still awaiting approval from their ethics committee. A trial cannot resume without ethics committee approval, as per government guidelines.
The phase 1 and 2 trial is expected to be completed in 15 months, as per the government’s clinical trial registry.
Covaxin was the first indigenous vaccine candidate to receive the Drug Controller General of India V.G. Somani’s approval for a human trial.
There are about half a dozen vaccine candidates from India, with two of them getting approval for human trials and the rest in pre-clinical trials. Zydus Cadila Ltd’s vaccine is the other candidate that has received DGCI approval and will conduct a phase 1 and 2 study of 1,048 participants study. Human dosing of the vaccine candidate started earlier this week.
Bharat Biotech’s vaccine candidate has been in greater focus due to ICMR, the country’s apex biomedical research agency’s involvement, as well as due to a controversial letter written by ICMR director-general Balram Bhargava earlier this month.
In the letter, he directed the company and the principal investigators of the 12 sites to expedite the trials so as to launch the vaccine by 15 August. The letter attracted significant criticism for presuming a positive result of a clinical study and flouting other ethical norms.
The agency has since seemingly backtracked from the deadline and justified the letter by saying it was only meant to expedite the trial by removing red tapes.
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