2 min read.Updated: 17 Jul 2020, 04:15 PM IST Written By Anulekha Ray
Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune
ICMR has selected 12 sites to conduct the clinical trials of Covaxin
As the novel coronavirus continues to spread around the world, scientists and researchers are scrambling to develop a vaccine to protect millions of people from infection. The human trial of Covaxin, India's first vaccine candidate against novel coronavirus infection, started last week. All India Institute of Medical Sciences in Patna and Post-Graduate Institute of Medical Sciences in Rohtak have begun the clinical trial of the COVID-19 vaccine candidate. The vaccine 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 I and II human clinical trials.
Here are the things that we know so far about India's first indigenous COVID-19 vaccine candidate:
1) 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.
2) “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.
3) Covaxin underwent pre-clinical testing on animals to see if it is safe. "Results from these studies have been promising and show extensive safety and effective immune responses," the company earlier said.
4) 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.
5) According to several reports, the first dose of the vaccine has been administered to the study participants. They will be given he second dose after an interval of 14 days. Once their schedule is complete, the volunteers will be examined thoroughly for any after-effects of the vaccine.
6) The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received ICMR’s letter. Only institutes with clinical pharmacology departments were selected for the trials of Covaxin.
7) Covaxin will be tested on over 1,100 people in two phases. Bharat Biotech has planned to enroll 375 people in the first phase of clinical trials. Depending on the results of the first trial, the company has a plan to enroll 750 people in the second phase of trial.
8) The human trial of India's first vaccine candidate has initiated in Rohtak’s Post-Graduate Institute of Medical Sciences today. "Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse efforts," said Anil Vij, health minister of Haryana.
9) "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," said Bill Gates.
10) "From India's perspective, we have two vaccine candidates. We are trying all out efforts to fast-rack it and it is the moral duty that there should not be a delay not even by a day for regulatory clearances for these vaccines so that we can break the transmission of the virus as soon as possible," said ICMR Director General Balram Bhargava.
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