India’s first mRNA COVID-19 vaccine gets Emergency Use Authorization

29 June 2022 | News

It is a two dose vaccine to be administered intramuscularly at 28 days apart

image credit- shutterstock

image credit- shutterstock

Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, has announced that its mRNA vaccine – GEMCOVAC-19 - has received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI).

GEMCOVAC-19 is the very first mRNA vaccine developed in India and only third mRNA vaccine to be approved for COVID-19 in the world. 

Gennova’s GEMCOVAC-19 has reached the primary end point of the Phase III clinical trial. The clinical data was evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic.

Gennova Biopharmaceuticals aims to produce around 40 - 50 lakhs of doses per month and this capacity can be quickly doubled.

Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of pandemic.


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