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ZyCov-D vaccine, the world’s first DNA vaccine

  • Category
    Science & Technology
  • Published
    14th Jul, 2021

Ahmedabad-based ZydusCadila has applied to Central Drugs Standard Control Organisation (CDSCO), the national drugs regulator, seeking emergency use authorisation (EUA) for ZyCov-D, its Covid-19 vaccine.

Context

Ahmedabad-based ZydusCadila has applied to Central Drugs Standard Control Organisation (CDSCO), the national drugs regulator, seeking emergency use authorisation (EUA) for ZyCov-D, its Covid-19 vaccine.

  • If approved by the regulator, ZyCov-D will be the world’s first DNA vaccineagainst infection with SARS-CoV-2.

About

About the ZyCov-D vaccine or DNA vaccine

  • ZyCov-D is a “plasmid DNA”. These DNA are engineered to show the desired results.
  • The plasmids used in the vaccine are coded with the instructions to make the spike protein of SARS-CoV-2.

Plasmid

  • plasmid is a small, circular, double-stranded DNA molecule that is distinct from a cell's chromosomal DNA. 
  • Plasmids naturally exist in bacterial cells, and they also occur in some eukaryotes.
  • Often, the genes carried in plasmids provide bacteria with genetic advantages, such as antibiotic resistance.
  • Vaccination gives the code to cells in the recipient’s body, so they can begin making the spiky outer layer of the virus.
  • The immune system is expected to recognize this as a threat and develop antibodies in response.
  • ZyCov-D will be given in three doses, with an interval of 28 days between the first and second and second and third shots.
  • No needle is used to deliver the vaccine, instead, a spring-powered device delivers the shot.
  • ZyCov-D has been developed with the support of the central government’s Department of Biotechnology and the Indian Council of Medical Research (ICMR).

Safety concerns

  • Safety concerns to integrate into cellular DNA or cause auto-immune diseases.

Emergency Use Authorization

  • In the current pandemic situation, it may not be possible to have all the evidence that a drug regulator would normally require for approving a drug, vaccine, device or test.
  • When there is a declared emergency, the regulator, in India’s case the DCGI, can take a call whether it is worth releasing a drug or vaccine that is not fully tested for efficacy and safety.
  • If there is evidence to suggest it may benefit patients, then the regulator is well within its rights to issue an emergency use authorisation to a medical product to make it widely available for use.

Vaccines approved under the EUA

  • The process for using the EUA is less clearly spelt out in India, but the DGCI has also been issuing EUAs based on clinical trial data.
  • In January, the DCGI approved the first two vaccines
    • Covishield, produced by Pune-based Serum Institute of India under licensing agreement from AstraZeneca
    • Covaxin, manufactured by Bharat Biotech
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