The Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for India`s first mRNA COVID-19 vaccine, sources told ANI on Tuesday. 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, people in the know told ANI. The company submitted data in April and provided additional data in May. Earlier in May, Gennova had released a statement to ANI regarding updates on submitting phase 3 data.
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"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 degrees Celcius, is a challenging journey during pandemic times," the spokesperson further said.
The company has conducted phase 2 and phase 3 data trials on 4000 participants to evaluate vaccine safety, immunogenicity and tolerability. The vaccine - GEMCOVAC-19 - is the country`s first homegrown mRNA COVID- 19 vaccine and is seen as a game-changer for the healthcare industry.
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