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COVID-19: DCGI Clears India's Indigenous MRNA Vaccine For Phase 2/3 Clinical Trials

Under India's COVID-19 vaccination expansion strategy, the Drug Controller General of India (DCGI) on Tuesday gave approval to India's first mRNA based vaccine

COVID

Image: ANI


Under India's COVID-19 vaccination expansion strategy, the Drug Controller General of India (DCGI) on Tuesday gave approval to India's first mRNA-based vaccine against COVID-19 to test its efficacy further 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. The Gennova Biopharmaceuticals is a part of the  Emcure group of companies and is based in Pune. The biotechnology company has been working on the nation’s first mRNA-based Covid-19 vaccine, since last year and has cleared the safety protocols in the first phase of trials.

 

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

Zydus Cadila's vaccine gets DCGI nod for EUA

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

"Zydus Cadila 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 administered in humans including children and adults 12 yrs and above," the Ministry of Science & Technology announced. Developed in partnership with the Centre's Department of Biotechnology under the ‘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 the category of vaccines being produced using modern technology. Genetic vaccines induce the genetic material needed to create the COVID-19 immunization in the host. mRNA and DNA vaccines are other names for them. These vaccines contain genetic elements that code for pathogen antigens (specific proteins). Human cells take up the DNA/ mRNA and create proteins based on the genetic information in the plasmid (mRNA/ DNA) that they have taken up. These genes in the coronavirus vaccine code for the S-protein or Spike protein, which forms the coronavirus's outer layer. 

Image: ANI

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