First mRNA COVID-19 vaccine will shortly be approved for emergency use
28 June, 2022 | Vaishali Sharma
Earlier in May, Gennova provided an update to ANI on the status of phase 3 data submission.
During a meeting on Friday, the Subject Expert Committee (SEC) accepted the Emergency Use Authorisation (EUA) for India’s first mRNA COVID-19 vaccine, sources said ANI on Tuesday. The Drugs Controller General of India (DCGI) is expected to approve Emergency Use Authorization for Gennova’s mRNA vaccine soon.
According to reports, the SEC, India’s drug regulator, deemed Gennova Biopharmaceuticals’ proof satisfactory at the meeting on Friday.
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.