Bharat Biotech submits Covaxin phase-III clinical trial data to DCGI

Hyderabad-based biotechnology company Bharat Biotech has submitted phase-III clinical trial data of its COVID-19 vaccine Covaxin to the Drugs Controller General of India (DCGI).

Covaxin is one of the three vaccines being used in India's vaccination programme against COVID-19 currently. The company has been facing questions over the delay in announcing results of phase-III trials.

"Bharat Biotech submitted Phase 3 clinical trials data of Covaxin to Drugs Controller General of India (DCGI) over the weekend," news agency ANI said quoting government sources.

Bharat Biotech submitted Phase 3 clinical trials data of COVAXIN to Drugs Controller General of India (DCGI) over the weekend: Govt sources pic.twitter.com/ggXSxQCaAc

- ANI (@ANI) June 21, 2021

Trial data for phase-III is crucial as it will provide details of the efficacy of the vaccine, which was developed in association with the Indian Council of Medical Research (ICMR). Phase-III trial data is also required for getting emergency use listing (EUL) from the World Health Organisation (WHO).

WHO has accepted Bharat Biotech's Expression of Interest (EoI) for EUL for Covaxin and scheduled a pre-submission meeting on June 23.

Earlier, the company had said it will submit the data to drug regulator, followed by peer-reviewed journals, with a timeline of three months for publication. Complete results of Covaxin's phase-III trial data will be made public during July.

In March, the vaccine maker said Covaxin demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose.

In January, DCGI had granted permission for emergency use of Covaxin based on its phase-I and phase-II clinical trial data.

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