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Coronavirus: India’s first mRNA Covid-19 vaccine to get emergency use authorisation soon
The Gemcovac-19 shot has been tested on 4,000 people
The Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for India’s first mRNA Covid-19 vaccine.
The Drugs Controller General of India (DCGI) is expected to give Emergency Use Authorisation to Gennova’s mRNA vaccine any time soon.
The SEC under India’s drug regulator found data submitted by Gennova Biopharmaceuticals satisfactory in the Friday meeting, sources told ANI on Tuesday.
The company submitted the data in April and provided additional data in May.
Earlier in May, Gennova released a statement to ANI regarding updates on submitting phase 3 data.
“Gennova is in communications with the regulatory agency and submitting all necessary data and information required for the product approval,” said Gennova’s spokesperson.
“Product development using innovative technologies like mRNA, a fourth-generation vaccine platform stable at 2 to 8°C, is a challenging journey during pandemic times,” the spokesperson further said.
The company has conducted phase 2 and phase 3 data trials on 4,000 participants to evaluate vaccine safety, immunogenicity and tolerability.
The vaccine - GEMCOVAC-19 - is the country’s first home-grown mRNA Covid-19 vaccine.
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