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India


Gennova's mRNA Covid-19 vaccine gets drug regulator's nod for phase II/III trial

Gennova's mRNA Covid-19 vaccine gets drug regulator's nod for phase II/III trial

New Delhi, Aug 24 (UNI) Pune-based biotechnology firm Gennova Biopharmaceuticals Ltd has received approval from the Drug Controller General of India (DCGI) to conduct a phase II/III trial of its Covid-19 vaccine candidate in the country, the Centre informed on Tuesday.
The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III, the union government informed.
The company had submitted interim clinical data of the Phase I study of its vaccine to the Centre's Central Drugs Standard Control Organisation (CDSCO). The Subject Expert Committee (SEC) reviewed the data and found Gennova's jab, HGCO19, safe, tolerable, and immunogenic in the study participants, as per the information shared by the officials.

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