Bharat Biotech has submitted data from phase 3 trials of its vaccine (Covaxin) to the Drugs Controller General of India (DCGI). The Hyderabad-based drugmaker has developed India’s only indigenous shot against the coronavirus disease (Covid-19), Covaxin.

A senior government official stated, “We have received the data from phase 3 trials.”

As per reports, the Subject Expert Committee (SEC) is likely to meet on Tuesday to review the phase 3 data.

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The reported development comes amid a controversy over data from the third stage trials of Covaxin which Bharat Biotech had earlier said that it would make public in June. It announced later that the data would, in fact, be made public in July, a delay of about a month from the originally announced timeline.

On June 9, company had said, “It is critical to understand, and further emphasise the phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier, COVAXIN phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for COVAXIN.”

Bharat Biotech’s Covaxin is among three vaccines being used in the nationwide drive against Covid-19. In January, it was granted approval by the DCGI, along with the Oxford University-AstraZeneca shot which is being manufactured locally by the Pune-based Serum Institute of India (SII) as Covishield. In April, the third vaccine, Russia’s Sputnik V, was granted emergency use authorisation (EUA).

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The vaccination drive in India against the coronavirus disease began on January 16. But, doubts have been raised on Covaxin’s efficacy as the vaccine was granted EUA without the completion of its third stage trials. Interim data was released by Bharat Biotech in April. It showed that the shot was 78% effective against symptomatic disease and 100% against serious illness.

Last week, Bharat Biotech refuted rumours that it had submitted phase 3 data to the World Health Organization’s (WHO) for the global health body’s approval. It called such reports “incorrect and lacking any evidence.” Recent reports claimed that WHO would review Bharat Biotech’s application on June 23.

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The company is also expected to hold a ‘pre-submission’ meeting on Wednesday with the World Health Organization for international emergency use listing (EUL.  Before final submission for approval, a ‘pre-submission’ meeting will provide an opportunity to receive guidance from WHO authorities. EULs involve rigorous assessment of clinical trial data. They also involve data on safety, efficacy and quality and cover a risk management plan.

An EUL from WHO will allow Bharat Biotech to export its vaccines. This will enable easier international travel for Indian citizens vaccinated with Covaxin. The vaccine is not yet recognised as a valid Covid-19 vaccine by foreign governments.