Bharat Biotech has 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 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 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. EULs involve rigorous assessment of clinical trial data – as well as data on safety, efficacy and quality – and a risk management plan.
An EUL 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.
Earlier this month the company said it would publish trial results in July and apply for a full licence. Further trials – to test for “real world effectiveness” have also been scheduled, it added.