DCGI expert panel meet today to review the Phase III data of Bharat Biotech's Covaxin - KEY EXPECTATIONS

The Subject Expert Committee (SEC) under the drug regulator will meet on Tuesday, June 22 to review the Phase III data of Bharat Biotech's Covaxin.

"Subject Expert Committee to meet today to review the Phase 3 data of Bharat Biotech's COVAXIN: Govt sources," ANI tweeted.

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The meeting is happening before Bharat Biotech's pre-submission meeting on Wednesday with the World Health Organization (WHO), for the approval for their Covid vaccine named 'Covaxin', as per a report by ANI.

The Hyderabad-based Covid vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend, according to government sources, as per ANI.

Subject Expert Committee to meet today to review the Phase 3 data of Bharat Biotech's COVAXIN: Govt sources

— ANI (@ANI) June 22, 2021

"We have received the data from the phase III trials," a senior government official confirmed.

Bharat Biotech's Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine have been questioned various times and that is what makes the data crucial which will ascertain the efficacy of the vaccine.

The vaccine has been developed by the company in association with the Indian Council of Medical Research (ICMR).

Union Health Ministry, Dr V K Paul, who is a member (Health) NITI Aayog and also the head of the Covid task force of the country, had earlier said that the company would be submitting the data within seven to eight days.

Bharat Biotech had in May informed that an emergency use listing (EUL) application had been submitted to WHO, with regulatory approvals expected between July and September.