Covaxin, the coronavirus vaccine from Hyderabad-based Bharat Biotech, has been recommended for "restricted use in emergency situation in public interest" by a government-appointed panel, which submitted its findings to the Drugs Controller General of India on Saturday evening.
The DCGI will take the final call on approving of the vaccine. The national regulator is scheduled to address the media at 11 am Sunday.
The recommendation comes despite the lack of efficacy data at this time. Covaxin has completed only two of three trial phases; the third - which tests for efficacy and which the company has called "the largest... ever conducted in India" - began in November.
Vaccine efficacy data is the result of combined analysis of all three phases.
However, Dr Savita Verma, a pharmacology professor from Haryana's PGIMS who is part of the team working on the vaccine, told NDTV that "good efficacy was shown" in the earlier trial phases.
"We have very robust Phase I and II results, in which good efficacy was shown. We are at present carrying out Phase III trials... have to recruit around 25,800 participants. As of now we have approximately 22,000 across India... we expect interim results by March," Dr Verma said.
Dr Verma also said that around 10 million doses of Covaxin are ready at this point.
Interim findings of Phase I trials showed Covaxin induces an immune response and registers no serious side effects. Phase II trial data showed "tolerable safety outcomes" and suggested antibodies may persist for six to 12 months.
Restricted use approval is normally only granted if there is sufficient evidence to suggest the drug is both safe and effective.
The recommendation comes a day after the panel sent another drug - Covishield, developed by AstraZeneca and Oxford University, and manufactured by Pune's Serum Institute - for approval. The vaccine will "protect 95 per cent of (its) patients", Pascal Soriot, AstraZeneca CEO, said last week.
Serum Institute CEO Adar Poonawalla said the "majority of the first 50 million doses will go to India".
A third vaccine - developed by American pharma giant Pfizer - had also applied for emergency fuse authorisation and is currently being reviewed by the panel. Sources, however, have said that the company has yet to present its data before the panel.
The Pfizer vaccine has already been rolled out in the UK, the US and some other countries.
The government on Saturday conducted a day-long trial run of the vaccine delivery system to check for potential problems once a vaccine is made available. The Health Ministry said dry runs were held in 116 districts, with nearly one lakh personnel undergoing necessary training.
The Health Minister, Dr Harsh Vardhan, said this morning that there should be no misconceptions about the safety of the coronavirus vaccines that India plans to use. He also reiterated that there was no evidence to suggest the vaccines could not protect against mutated strains of the virus.
Dr Vardhan also said that around three crore frontline workers, including doctors, nurses and essential services like the police, will be first in line to be vaccinated.
With input from PTI