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GEMCOVAC-OM is a thermostable, self-amplifying mRNA (samRNA) vaccine developed by Gennova Biopharmaceuticals for the prevention of COVID-19 caused by the SARS-CoV-2 Omicron variant. The vaccine encodes the spike protein of the Omicron BA.1 lineage. Unlike first-generation mRNA vaccines that require ultra-cold storage, GEMCOVAC-OM is lyophilized and stable at standard refrigeration temperatures (2-8°C), significantly lowering the logistical barriers for distribution in diverse climates. It is administered intradermally using the Tropis needle-free injection system. In June 2023, the Drug Controller General of India (DCGI) granted Emergency Use Authorization for GEMCOVAC-OM as a booster dose in adults who have completed primary vaccination with COVISHIELD or COVAXIN.
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