With the rising number of novel coronavirus cases increasing at a pace of daily highs in the country for the past few days, India’s first indigenous Covid-19 vaccine Covaxin got a nod from the AIIMS Ethics Committee on Saturday to start human trials from Monday.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin. In phase I, the vaccine would be tested on 375 volunteers and a maximum of 100 of them would be from AIIMS.
Moreover, human dosing of the vaccine developed by Bharat Biotech India (BBIL) in collaboration with ICMR’s National Institute of Virology (NIV) also 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 said in a statement on Friday.
The biotech company had got the nod for human clinical trials from the Drugs Controller General of India (DCGI) earlier this month.
Here are the major updates that we know about India’s first indigenous COVID-19 vaccine candidate so far:
1) The AIIMS Ethics Committee gave its nod for a human clinical trial to begin from tomorrow. “Healthy volunteers having no co-morbid conditions and without a history of Covid-19, aged more than 18 years and less than 55 years, would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial,” Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said. Anybody willing to participate in the trial can send an email to Ctaiims.firstname.lastname@example.org or an SMS to or call on 7428847499, he said.
2) The human trials of Covaxin has begun at the All India Institute of Medical Sciences, Patna. AIIMS-Patna chose 10 volunteers to start the human trial of Covaxin.
3) 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.
4) The trials have so far started in AIIMS, Patna, and some more sites. Earlier, Haryana’s health minister Anil Vij tweeted that human trial with Bharat Biotech’s coronavirus vaccine ‘Covaxin’ started at PGIMS Rohtak as well.“Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse efforts,” Vij tweeted.
5)The human clinical trials for Covaxin had been initiated across the country with 375 volunteers, sources from Bharat Biotech said on Friday.
6) Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune. Bharat Biotech developed an “inactivated” vaccine at its high-containment facility at Genome Valley in Hyderabad.
7) “Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” said the company.
8) On Thursday, Microsoft co-founder and philanthropist Bill Gates claimed the Indian pharmaceutical industry will be able to produce Covid-19 vaccines not just for the country but also for the entire world. “India has a lot of capacity there — with the drug and vaccine companies that are huge suppliers to the entire world. You know, more vaccines are made in India than anywhere — starting with Serum Institute, that’s the largest,” he said.
9) Drug firm Zydus Cadila also said it has started human clinical trials of its COVID-19 vaccine candidate ZyCoV-D. In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it said in a regulatory filing.
10) The DCGI has permitted two vaccines — one developed by the Bharat Biotech International Limited in collaboration with the ICMR and another one by Zydas Cadila Healthcare Ltd to go in for phase I and II human clinical trials.
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