The Subject Expert Committee (SEC) approved Emergency Use Authorisation (EUA) for India’s first mRNA COVID-19 vaccine during a meeting on Friday, sources informed ANI on Tuesday. The Drugs Controller General of India (DCGI) is anticipated to grant Gennova’s mRNA vaccine Emergency Use Authorization soon.
In the Friday meeting, the SEC, India’s drug regulator, judged Gennova Biopharmaceuticals’ evidence sufficient, according to sources.
The corporation supplied data in April and updated it in May.
Earlier in May, Gennova provided an update to ANI on the status of phase 3 data submission.
“Gennova is in discussion with the regulatory authorities and has submitted the relevant data and information for product approval,” stated a spokesman for the company.
“During pandemic times, product development employing novel technologies like mRNA, a fourth-generation vaccine platform stable at 2 to 8 degrees Celsius, is a tough path,” the representative added.
On 4000 people, the business performed phase 2 and phase 3 data trials to assess vaccination safety, immunogenicity, and tolerability.
The vaccine, GEMCOVAC-19, is the country’s first indigenous mRNA COVID-19 vaccine and is widely regarded as a game changer in the healthcare business.