News: Three volunteers were administered Covaxin.
During phase-1, 3 volunteers were administered Covaxin at the Post Graduate Institute of Medical Sciences (PGIMS) in Rohtak.
Volunteers were administered the vaccine after health checks to ensure proper liver function and the absence of infection.
After 2 hours of administered vaccine, no major complications were observed.
Volunteers will be given the 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.
The vaccine will be tested on over 1,100 people in two phases.
The entire process might take six months and the final assessment on safety and the level of production of antibodies would be made by a safety board.
Covaxin is India’s first indigenous vaccine. Its development has reached Clinical trials- phase -1 stage.
Vaccine developed by: Hyderabad based Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.
Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune.
It is an “inactivated” vaccine i.e. it is a killed virus with no potential to infect or replicate, once injected into the body.
What are the phases of vaccine development?
Phase 1- It involves a basic understanding of the virus to identify the structure of proteins and genetics that make up the virus. It provides a basis for developing diagnostics kits and potential treatment options.
Phase-2– It involves the identification of vaccine candidates by isolating the live virus before inactivating or weakening that can be used for immunity development.
Phase -3 – Pre-clinical testing: It involves testing of the vaccine on animals before starting clinical trials on human.
Phase -4 – Clinical trials: It involves testing on humans. There are 3 phases of clinical trials
- Phase I of a clinical trial only indicates what is the ideal dose required to administer in the next stage, it provides evidence of the vaccine’s ability to generate an immune response and its safety. It involves a small number of participants in the trial.
- In phase II, the age range of participants is expanded to see if there is variation in the immune response between older people and children and it also assesses the time period for which antibodies last to provide immunity against the virus.
- Phase-III involves a very large group of people to investigate its efficiency among large population groups.
Phase- 5: It involves regulatory approval before the mass production of a vaccine starts.
Phase -6: It involves the production of Vaccine.