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Tags Current Affairs

Covaxin

Date: 01 July 2020 Tags: Biotechnology

Issue

India’s top drug regulator, the Central Drugs Standard Control Organisation, has allowed Bharat Biotech India (BBIL) to conduct human clinical trials for ‘Covaxin’, making it the first indigenously developed Covid-19 vaccine candidate to receive this approval.

 

Background

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.

 

Details

  • Covaxin is a vaccine candidate to be developed by BBIL against the novel coronavirus (Covid-19) in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).

  • 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 dead 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.

  • BBIL’s Covaxin then underwent pre-clinical testing, when the vaccine is tested on animals like guinea pigs and mice to see if it is safe, before the firm approached CDSCO for approvals to move on to the next stage of testing–human trials.

  • 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.

  • Other Indian firms engaged in the development of Covid-19 vaccines include Zydus Cadila, Serum Institute of India and, since earlier this month, Panacea Biotec.

 

Other potential vaccines

  • AstraZeneca, whose vaccine candidate “ChAdOx1-S” with the University of Oxford is already at phase III trials, is the frontrunner. Serum Institute has an agreement to manufacture this vaccine.

  • Moderna, which is also close to beginning phase III trials for its LNP-encapsulated mRNA vaccine candidate with the National Institute of Allergy and Infectious Diseases, is close behind.

  • Globally, Zydus Cadila’s DNA plasmid and measles vector vaccines as well as Serum’s codon deoptimised live attenuated vaccine, which it is developing with Codagenix, are still in the pre-clinical stage.

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