Bharat Biotech gained an edge in the race among a few entities in the country and several more globally to ready a vaccine for COVID-19 when the Drug Controller General of India (DCGI) cleared its product for human clinical trials.
What is ‘Covaxin’?
- Covaxin is a vaccine candidate to developed by BBIL against the novel coronavirus (Covid-19) in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).
- As part of this collaboration, NIV isolated a strain of the virus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May. The firm then used it to work on developing an “inactivated” vaccine–a vaccine that uses a the dead virus–at its high containment facility in Hyderabad.
- 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.
What does the approval mean for India?
- The Drug Controller General of India, who heads CDSCO, has given Bharat Biotech approvals to begin testing its vaccines on humans through phase I and II clinical trials.
- This brings India a step closer to finalising a domestically developed Covid-19 vaccine for its population–a positive sign at a time when the country’s cases continue to surge, especially in the national capital.
- The first phase, usually conducted on a small group of individuals, tries 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 conducted on a larger group comprising hundreds of persons fitting the description of those for whom the vaccine is intended using characteristics like age and sex. This phase tests how effective the vaccine is on the population group being studied.