Bharat Biotech on Tuesday submitted Phase III trial data for the Covaxin coronavirus vaccine to the DCGI (Drug Controller General of India).
The drug regulator’s SEC (subject expert committee) is expected to meet later today – likely around noon – to discuss the results. The data has not yet been fully published in a recognised, peer-reviewed journal.
Hyderabad-based Bharat Biotech is also expected to hold a ‘pre-submission’ meeting 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. EULs involve rigorous assessment of clinical trial data – as well as data on safety, efficacy and quality – and a risk management plan.
Emergency use approval from WHO will allow Bharat Biotech to export its vaccines and enable easier international travel for Indian citizens vaccinated with Covaxin, which is not yet recognised as a valid COVID-19 vaccine by foreign governments.
In March Bharat Biotech released a “first interim analysis” of Phase III trial results, and said it: “… demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose.”