COVID-19: DCGI clears India's indigenous mRNA vaccine for phase 2/3 clinical trials

Under India's COVID-19 vaccination expansion strategy, Drug Controller General of India (DCGI) on Tuesday gave approval to India's first mRNA-based vaccine against COVID-19 to test its efficacy furr in  2nd & 3rd phase trials, as it was found safe and effective in phase 1 trials.

India’s  first mRNA based vaccine

DGCI gave a green nod to Gennova Biopharmaceuticals Ltd's COVID-19 vaccine. This is India's first indigenously developed mRNA vaccine. Gennova Biopharmaceuticals is a part of   Emcure group of companies and is based in Pune.  biotechnology company has been working on nation’s first mRNA-based Covid-19 vaccine, since last year and has cleared safety protocols in  first phase of trials.

company submitted Phase I study's interim clinical results to Central Drugs Standard Control Organisation (CDSCO), India's National Regulatory Authority (NRA).  update has just arrived days after DGCA gave clearance to Zydus Cila's DNA-based vaccine--ZyCoV-D. This will provide a boost to India's ongoing vaccination strategy to inoculate  maximum population as early as possible, in order to abate future COVID-19  waves. 
 

Zydus Cila's vaccine gets DCGI nod for EUA

Zydus Cila received Emergency Use Authorization (EUA) by  Drugs Controller General of India (DCGI) for its COVID vaccine ZyCoV-D on Friday. vaccine from Ahmedab-based pharmaceutical company is now world’s first and India’s indigenously developed DNA-based vaccine for humans including children and ults 12 years and above.

"Zydus Cila receives approval for Emergency Use Authorization from DCGI  for ZyCoV-D today. World’s first and India’s indigenously developed DNA based vaccine for COVID-19 to be ministered in humans including children and ults 12 yrs and above," Ministry of Science & Technology announced. Developed in partnership with Centre's Department of Biotechnology under ‘Mission COVID Suraksha’, ZyCoV-D has been supported under COVID-19 Research Consortia through National Biopharma Mission for Preclinical studies. 

Genetic Vaccines

Genetic Vaccines come under category of vaccines being produced using modern technology. Genetic vaccines induce genetic material needed to create COVID-19 immunization in host. mRNA and DNA vaccines are or names for m. se vaccines contain genetic elements that code for pathogen antigens (specific proteins). Human cells take up DNA/ mRNA and create proteins based on genetic information in plasmid (mRNA/ DNA) that y have taken up. se genes in coronavirus vaccine code for S-protein or Spike protein, which forms coronavirus's outer layer. 

Image: ANI