The DCGI Subject Expert Committee (SEC) accepted Covaxin's Phase 3 trial findings on Tuesday, which demonstrated 77.8% effectiveness.

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In Phase 3 trials, Bharat Biotech's Covaxin was found to be 77.8% effective, and the data was approved by a government panel.

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Wednesday, 23rd June 2021

In phase 3 trials, the Hyderabad-based biotechnology company Bharat Biotech's Covaxin showed 77.8% effectiveness. Government sources told CNN-News18 on Tuesday that the company's phase 3 trial efficacy results had been authorized by the Centre's Subject Expert Committee (SEC). The Drugs Controller General of India (DCGI) is also expected to approve Covaxin today.

Over the weekend, Bharat Biotech submitted phase-III clinical trial results for their vaccine to DCGI.

The data has yet to be published in a peer-reviewed journal with international acclaim. Bharat Biotech had previously stated that the data will be public after it was filed to the national authority and would be available in three months.

Bharat Biotech had previously stated, "It is crucial to realize that Phase 3 data will first be submitted to CDSCO (the Central Drugs Standard Control Organization)... followed by peer-reviewed journals with a timetable of about three months for publication."

Also Read: Coronavirus Status in Maharashtra: Cases Rose From a Four-Month Low on Monday to 8,470 New Infections a Day Later

On Tuesday, the SEC, a group of independent experts who advise the national drug regulator, met to review phase three data for the "made in India" Covaxin. The DCGI had granted permission for emergency use of Covaxin in January based on its phase 1 and 2 clinical trials, which included about 680 participants.

Bharat Biotech will be able to obtain a EUL (emergency use listing) from the World Health Organization when the DCGI approves Covaxin's phase 3 data (WHO). The vaccine has yet to be approved by other governments, and Bharat Biotech has faced obstacles since the US Food and Drug Administration denied emergency use of its vaccinations on June 11th.

Bharat Biotech will be able to export its vaccine thanks to the WHO's EUL, which will also make international travel easier for Indian citizens who have received Covaxin doses.


The News Talkie Bureau




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