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Adult emergency use of the indigenous mRNA Covid vaccine is approved by DCGI: Report

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Published By:
Peeyush Ghalot
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Published On:
02-07-2022
(Image Courtesy: - PAHO)

The mRNA Covid-19 vaccine, manufactured by Gennova Biopharmaceuticals in Pune, has received approval from the Drugs Controller General of India (DCGI) for restricted use in emergency conditions for recipients older than 18 years of age. For the first time ever, even when stored at 2 to 8 degrees Celsius, this vaccine maintains its stability. India's first mRNA vaccine has been recommended for Emergency Use Authorization (EUA) by the Subject Expert Committee (SEC). The Gennova Biopharmaceuticals data was deemed "sufficient" by the Subject Expert Committee of India's medicines regulator. Data was provided by the firm in April. Later, in May, they provided further new information. In order to have the product approved, Gennova is in contact with the regulatory body and has provided the relevant data and information. A difficult road during pandemic times is product development employing cutting-edge technology like mRNA, a fourth-generation vaccination platform that is stable at 2-8 degrees Celsius. The business tested the safety, immugenicity, and tolerability of the vaccines on 4000 volunteers throughout phases 2 and 3. The Union Government is dedicated to stepping up and broadening the Covid-19 immunisation programme nationwide. On January 16, 2021, the countrywide Covid-19 immunisation programme began. On June 21, 2021, the second phase of the Covid-19 immunisation programme went into effect. The availability of additional vaccinations, early notification of vaccine availability to States and UTs for improved planning by them, and simplifying the vaccine supply chain have all increased the vaccination campaign. The Government of India has been assisting the States and UTs by giving them free Covid-19 vaccinations as part of the national immunisation push. The Union Government would purchase and provide (free of charge) to States and UTs 75% of the vaccinations being manufactured by the country's vaccine producers as part of the next phase of the Covid-19 immunisation push.

Reference: - https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dcgi-approves-indigenous-mrna-covid-jab-for-emergency-use-in-18-yrs-above-covovax-for-7-11-yrs/articleshow/92527829.cms?from=mdrn