GEMCOVAC®-OM, a first-time -in-India mRNA booster vaccine, specifically designed to protect patients from the Omicron variant of the COVID-19 virus.
The vaccines received Emergency Use Authorization EUA on June 19, 2023, from the office of the DCG I .
It is a “made-in-India vaccine, using mRNA platform technology for the first time in India.
GEMCOVAC®-OM is a lyophilized vaccine that is stable at 2-8 °C and could be distributed through the existing refrigeration cold chain and does not require ultra-low temperature storage conditions, a prerequisite for other approved mRNA vaccines in the world. The additional feature of this vaccine is that it is administered via the intradermal route using a device called Tropis, developed by the US-based company Pharmajet. This is a needle-free device, and it has been used on millions of children for polio vaccination and has demonstrated an increased preference for this route of vaccine delivery.
Omicron-specific vaccine GEMCOVAC®-OM has been assessed for its safety and immunogenicity when administered as a booster to participants who have received two doses of COVISHIELD™ or COVAXIN® as their primary vaccination.
The vaccine is approved for patients in the age group of 18 years and older. Given the long-after effects of COVID-19 infection caused by the circulating Omicron virus variant, the scientific evidence overwhelmingly favors giving booster doses, particularly to the vulnerable population segment consisting of older patients, immune-compromised patients, and patients suffering from co-morbidities.
USP: Only mRNA-based Omicron-specific booster dose available in India
Only mRNA vaccine stable at 2 - 8 C - readily deployable through existing cold chain supply chain pan India.
Needle-free intradermal delivery.
Pandemic-Ready rapid development technology