The Pune-based manufacturer said that the clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO).
India’s first indigenously developed mRNA vaccine, GEMCOVAC-19, has been approved for emergency use by the Drug Controller General of India (DCGI) on Tuesday. The vaccine can be used for people who are 18 years and above. The vaccine has been developed by a Pune-based drugs manufacturer, Gennova Biopharmaceuticals.
The two-dose vaccine will be administered intramuscularly at 28 days apart. The company will sell the vaccine under the brand name GEMCOVAC-19.
“Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd., announced that its mRNA vaccine — GEMCOVAC-19 — against Covid-19 received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI),” said a statement from the vaccine manufacturer Gennova Biopharmaceuticals on Wednesday.
GEMCOVAC-19 is the first mRNA vaccine that has been developed in India. It will also be the only third mRNA vaccine to be approved for Covid-19 in the world.
The Pune-based manufacturer said that the clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic.
The company claimed that it aims to produce around 40 – 50 lakhs of doses per month and this capacity can be quickly doubled.
(With Inputs from IANS)
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