Hyderabad-based vaccine maker Bharat Biotech has submitted data from Phase III trials of its Covaxin coronavirus vaccine to the Drugs Controller General of India (DCGI), news agency ANI reported.
“We’ve received the data from phase 3 trials,” ANI quoted a senior government official as saying. The drug regulator’s SEC (subject expert committee) is expected to meet around noon to review the data. Notably, Bharat Biotech’s trial results have not yet been fully published in a recognised, peer-reviewed journal.
The drug-maker is likely to hold a ‘pre-submission’ meeting on Wednesday with the World Health Organization for international emergency use listing (EUL) of its vaccine. A ‘pre-submission’ meeting will provide an opportunity to receive guidance from WHO authorities before final submission.
Covaxin, India’s only indigenous shot against the coronavirus disease, is among three vaccines being used in the nationwide drive against Covid-19. In January, the drug regulator approved the use of Covaxin along with Covishield, the Oxford University-AstraZeneca shot which is being manufactured locally by the Pune-based Serum Institute of India (SII). A third vaccine, Russia’s Sputnik V, was granted emergency use authorisation (EUA) in April.
Earlier this month, the company announced that it would publish the trial data in July and will also apply for a full licence. The company told news agency ANI “it is critical to understand that Phase III data will first be submitted to CDSCO (the Central Drugs Standard Control Organisation)… followed by peer-reviewed journals with a timeline of approximately three months for publication.
The vaccination drive against the coronavirus disease began on January 16. However, since the beginning, doubts have been raised on Covaxin’s efficacy as the vaccine was granted EUA without the completion of its third stage trials. Interim data released by Bharat Biotech in April showed that the shot was 78% effective against symptomatic disease and 100% against serious illness.
Covaxin has been under scrutiny for not publishing the data from phase three trials with critics raising doubt at its efficacy. Interim data released by Bharat Biotech in April showed that the shot was 78% effective against symptomatic disease and 100% against serious illness.