The Drugs Controller General of India (DCGI) has approved two doses of Pune-based Gennova Biopharmaceuticals' mRNA Covid-19 vaccine for restricted use in emergency situations for beneficiaries aged above 18 years age group.
It is for the first time ever that this vaccine remains stable during storage even at 2-8 degrees Celsius, sources said on Tuesday.
The Subject Expert Committee (SEC) has recommended Emergency Use Authorisation (EUA) for India's first mRNA vaccine on Friday meeting, sources said to ANI.
The Subject Expert Committee under India's drug regulator has found data submitted by Gennova Biopharmaceuticals "satisfactory".
The company submitted data in the month of April. Then, they submitted more additional data in the month of May.
Earlier in the month of May, Gennova released the statement to ANI regarding updates on submitting phase 3 data which read, "Gennova is in communication with the regulatory agency and submitting all necessary data and information required for the product approval."
They also said, "Product development, using innovative technologies like mRNA, a fourth-generation vaccine platform is stable at 2-8 degrees Celsius, is a challenging journey during pandemic times."
The company has conducted phase 2 and phase 3 data trials on 4000 participants to evaluate vaccine safety, immugenicity and tolerability.
The Union Government is committed to accelerating the pace and expanding the scope of Covid-19 vaccination throughout the country. The nationwide Covid-19 vaccination started on January 16, 2021.
The new phase of universalization of Covid-19 vaccination commenced on June 21, 2021. The vaccination drive has been ramped up through the availability of more vaccines, advance visibility of vaccine availability to States and UTs for enabling better planning by them and streamlining the vaccine supply chain.
As part of the nationwide vaccination drive, the Government of India has been supporting the States and UTs by providing them with Covid-19 vaccines free of cost. In the new phase of the universalization of the Covid-19 vaccination drive, the Union Government will procure and supply (free of cost) 75 per cent of the vaccines being produced by the vaccine manufacturers in the country to States and UTs.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
You’ve hit your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →
Quarterly Starter
₹900
3 Months
₹300/Month
Smart Essential
₹2,700
1 Year
₹225/Month
Super Saver
₹3,900
2 Years
₹162/Month
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Access to Exclusive Premium Stories Online
Over 30 behind the paywall stories daily, handpicked by our editors for subscribers


Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share


Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor


Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements


Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app