GEMCOVAC-OM

• India’s first indigenous mRNA vaccine for the Omicron variant, GEMCOVAC-OM, developed by Pune-based Gennova Biopharmaceuticals Ltd, was approved under emergency use guidelines by the Drug Controller General of India
• It is a mRNA COVID-19 booster vaccine.
• It is a lyophilized (freeze dried) vaccine, stable at 2- 8 °C, is delivered using a device called Tropis.
  • Tropis use the technology that propels liquid at high pressure to deliver vaccines through the skin without utilising needles.
• Clinical trials and approval of new drugs/vaccines are governed by the New Drugs and Clinical Trial Rules 2019 under the provisions of the Drugs and Cosmetics Act, 1940.
• Central Drugs Standard Control Organisation (CDSCO) headed by the DCGI is the authority to grant approval of Vaccine.
• Vaccine Testing and subsequent approval involves preclinical phase (without testing on humans) and three phases of human clinical trials.

ABOUT MRNA VACCINE

• It is type of vaccine that use messenger RNA (mRNA) molecules to provide instructions to the body’s cells for producing a protein that triggers an immune response against a pathogen.
  • Messenger RNA is a type of RNA that is necessary for protein production.
• Once the mRNA is injected into the body, the cells read the instructions and produces the protein.
• This then stimulates the immune system to recognize and mount a response against the targeted pathogen.
• mRNA from vaccines does not enter the nucleus and does not alter DNA.