DCGI to receive Covaxin phase 3 trials data from Bharat Biotech

Bharat Biotech

Bharat Biotech, a Hyderabad-based pharmaceutical company that created Covaxin, India’s sole indigenous coronavirus vaccine, has submitted results from phase 3 trials to the Drugs Controller General of India (DCGI).

A top government official was quoted as saying, “We’ve received the data from phase 3 trials.” The Subject Expert Committee (SEC) is also expected to meet on Tuesday to analyse the phase 3 data, according to reports.

The results of phase 3 trials have been submitted to the Drugs Controller General of India by Bharat Biotech, a Hyderabad-based pharmaceutical business that developed Covaxin, India’s only indigenous coronavirus vaccine (DCGI).

In the nationwide campaign against Covid-19, Covaxin is one of three vaccines being deployed. The DCGI approved it in January, along with the Oxford University-AstraZeneca shot Covishield, which is produced locally by the Pune-based Serum Institute of India (SII). In April, a third vaccination, Russia’s Sputnik V, received emergency use authorization (EUA).

On January 16, a vaccination campaign against coronavirus sickness began. However, reservations about Covaxin’s efficacy have been raised as the vaccine was given EUA before the third stage studies were completed. According to preliminary data presented in April by Bharat Biotech, the shot was 78 per cent effective against symptomatic disease and 100 per cent effective against serious illness.

Bharat Biotech denied last week that it has submitted phase 3 data to the World Health Organization (WHO) for clearance, saying such assertions “incorrect and devoid of any evidence.” According to reports, the WHO will consider Bharat Biotech’s proposal on June 23.

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