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 to meet today 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.
The company also 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.
Phase II/III trials on children - on 525 "healthy volunteers" between two and 18 years old - began this month amid some concerns a third wave could affect kids, and the need to eventually expand vaccination to all sections of the population.
In March Bharat Biotech released a "first interim analysis" of Phase III results that indicated "81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose."
Covaxin was cleared for emergency use last year while still in clinical trials; it was given "restricted use in emergency situation in public interest", which raised questions and was also seen as contributing to vaccine hesitancy that marked the early stages of India's vaccination drive.
On Monday - the first day of a renewed push by the government to vaccinate eligible beneficiaries - over 86 lakh doses were administered across the country - a single-day record.
Prime Minister Narendra Modi called the numbers "gladdening".
Apart from Covaxin, the AstraZeneca-Oxford University vaccine (made and sold in India as Covishield) and Russia's Sputnik V are the only other shots available at this time. The government has said it is working with US pharma giants Pfizer and Moderna for use of their vaccines as well.
With input from ANI