Covishield and Covaxin gets green signal from the government for market supply

The Covid vaccines Covishield and Covaxin received regular market approval from an expert panel of India's central drug authority. A vaccine's market authorization label indicates that it can be used without reservations or constraints.

Both SII and Bharat Biotech acknowledged this, and the topic expert committee has given their permission (SEC).

"SEC has recommended for upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population, DCGI will evaluate the recommendations and give its decision," CDSCO (Central Drugs Standard Control Organization) also confirmed on Twitter.

An official source said, "The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) which reviewed SII and Bharat Biotech's application for the second time on Wednesday has recommended granting regular market approval to Covishield and Covaxin subject to certain conditions."

According to a person familiar with the marketing of these vaccines, they will be provided at Cowin-registered clinics and hospitals. The clinic/hospital will enter details in Cowin at the time of administration.

The Drugs Controller General of India (DCGI) had received applications from Serum Institute of India (SII) and Bharat Biotech requesting regular market authorization for their respective Covid-19 vaccines Covishield and Covaxin.

On October 25, SII's director of government and regulatory relations, Prakash Kumar Singh, filed an application with the DCGI.

DCGI had requested additional data and documentation from the Pune-based firm, to which Singh recently responded with additional data and information.

Singh is said to have remarked in the response that, in addition to the successful completion of the Phase 2/3 clinical research in India, more than 100 crore doses of the Covishield vaccine have been administered to the people of this country around the world.

He further said, "Such a large-scale vaccination with Covishield and containment of Covid-19 infection is in itself a testimony of the safety and efficacy of the vaccine." 

V Krishna Mohan, a full-time director at the Hyderabad-based company, provided detailed information on chemistry, production, and controls, as well as pre-clinical and clinical data, in an application to the DCGI a few weeks ago, requesting normal market authorization for Covaxin.

According to Mohan's application, Bharat Biotech International Limited (BBIL) accepted the challenge to develop, produce, and clinically evaluate a vaccine (Covaxin) based on SARS-CoV-2 strains obtained from COVID-19 patients in India.

On January 3, Covaxin and Covishield received Emergency Use Authorization (EUA).