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Home / News / India /  India's first COVID-19 vaccine trial at AIIMS Delhi: 30-year-old gets shot, no side effects so far. Key points

Covaxin, India's first COVID-19 vaccine candidates today has started its human trial at All India Institutes of Medical Sciences (AIIMS), Delhi. Over 2,000 volunteers have enrolled for the first phase of human clinical trial of Covaxin. India's COVID-19 vaccine has started the human trial on July 15. 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). AIIMS-Delhi is is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II trial.

1) A Delhi resident took the first dose of India's COVID-19 vaccine at AIIMS. "The first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm. No immediate side-effects have been observed so far. He was under observation for two hours and will be monitored for the next seven days," Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said.

The first volunteer was screened two days ago, according to reports by the news agency PTI.

2) In phase I, the vaccine will be tested on 375 volunteers. The second phase of trial will be conducted on 750 volunteers. For phase I trial, healthy people who are between 18-55 years old and do not have any co-morbid conditions will be selected. For phase II trial, people aged between 12-65 will be enrolled.

3) "In the first phase we see the safety of the vaccine which is of primary importance and the dose range is also calculated," said AIIMS Director Dr Randeep Guleria.

2) 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.

4) There are three formulations of the COVID-19 vaccine candidate. Each subject will be given any one of the formulation in two doses two weeks apart. The first 50 will get the lowest strength dose of the vaccine. If it is found to be safe in them, then it will be given to another 50 patients in high doses, Dr Rai told PTI.

5) The human trials of coronavirus vaccine have initiate at Goa's Redkar Hospital this week, confirmed state chief minister Pramod Sawant. "Human trials of Covaxin, an indigenously developed vaccine for COVID-19, has begun at Redkar Hospital in Goa. This is a testimony of India's immense potential in healthcare innovation. My best wishes to the entire team working on Covaxin," Sawant earlier tweeted.

6) The trial has also started at Nizams Institute of Medical Sciences, Hyderbad; Post-Graduate Institute (PGI) of Medical Sciences in Rohtak; AIIMS Patna; Institute of Medical Sciences and SUM (IMS & SUM) Hospital in Bhubaneswar among others.

7) The Drug Controller General of India (DCGI) earlier approved two vaccines — one developed by the Bharat Biotech and another one by ZydusCadila to go in for the first and second phase of human clinical trials.

8) At least seven Indian pharmaceutical companies are working on the coronavirus vaccine India. These firms are Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E.

9) On how Covaxin works, Bharat Biotech said, “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."

10) India has a fantastic "vaccine capability" and it would play a crucial role in the partnerships the UK is building on COVID-19 vaccine development and manufacturing, the new British High Commissioner earlier said.



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