Login With Google
Covaxin got approval for human clinical trials
Why is it in News?
- India’s drug regulator, the Central Drugs Standard Control Organization allowed to conduct human clinical trials for ‘Covaxin’
More on News
- It is developed by Bharat Biotech India and ICMR’s National Institute of Virology
- It is a ‘inactivated’ vaccine i.e. made up using dead covid-19 virus
- 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,
- vaccine is tested on animals like guinea pigs and mice to see if it is safe, before the firm approached CDSCO for approvals
- stages of testing
(1) It will follow 4 stages testing
(2) Pre-clinical testing where it is tested on guinea pigs and mice – before human trials
(3) Phase I – sill be conducted on a small group of individuals, tries to find what dosage of the vaccine is safe for use
(4) Phase II - It 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.
(5) Phase III - studies conducted on thousands of patients
- Other vaccines
(1) AstraZeneca - University of Oxford is already at phase III trials. Serum Institute has an agreement to manufacture this vaccine.
(2) Moderna - is also close to beginning phase III trials for its LNP-encapsulated mRNA vaccine candidate with the National Institute of Allergy and Infectious Diseases.