Govt panel accepts Covaxin phase-3 trial data

June 22, 2021 21:34

An expert panel of the country's central drugs authority has reviewed and accepted the phase-3 trial data of Bharat Biotech's COVID-19 vaccine Covaxin, sources said on Tuesday.

According to the data submitted by the Hyderabad-based firm, the indigenously developed vaccine has shown 77.8 per cent efficacy in the trial conducted on 25,800 subjects, they said.

The firm had submitted the results of its phase-3 trial efficacy data of Covaxin to the Drugs Controller General of India (DCGI) over the weekend, they added.

The COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday reviewed the data and accepted it.

Their recommendations have been sent to the DCGI now, a source said.

Bharat Biotech is also expected to attend a 'pre-submission' meeting on July 23 with the World Health Organisation (WHO), which will take the vaccine-maker closer to a WHO Emergency Use Listing (EUL).

Though the meeting will not be a detailed review on the product, the vaccine-maker will have an opportunity to submit a summary on the overall quality of the jab, according to the WHO.

The information was provided on the WHO website in the Status of COVID-19 Vaccines within WHO EUL-PQ evaluation process document. Covaxin is one of the three vaccines approved by the DGCI for emergency use and is being deployed in India's COVID-19 vaccination programme. -- PTI

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