India’s first candidate vaccine for COVID-19 is Covaxin, and the DGCI has approved it for phase 1 and 2 human clinical trials.
Covaxin, the first vaccine candidate developed in India, has been approved by the Drug Controller General of India (DCGI) for phase 1 and 2 human clinical trials scheduled to take place across the country in July 2020.
It is developed by Bharat Biotech International (BBIL) in Hyderabad, in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).NIV collected the virus from an asymptomatic COVID-19 patient and transferred it to BBIL in May. The firm then used the collected virus on developing an inactivated vaccine that uses the dead virus.
Covaxin underwent pre-clinical testing on animals like guinea pigs and mice before approaching CDSCO for human clinical trials.The first phase is for a small group of individuals that will try to find what dosage of the vaccine is safe for use, whether it is effective in building their immunity to the virus, and whether there are any side effects. The second phase is for a larger group comprising hundreds of people for whom the vaccine is intended, based on age and sex.
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