MUMBAI, Nov. 16 (Xinhua) -- Indian biotech company Bharat Biotech has commenced phase III clinical trials for the COVID-19 vaccine involving 26,000 volunteers across the country, the company said in a statement on Monday.

This is India's first Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in the country approved by the drug regulator, the statement said.

Volunteers will randomly receive two intramuscular injections approximately over 28 days apart. The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group, the statement said.

The proposed novel vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology.

India has reported 130,070 deaths due to COVID-19 and currently has 465,478 active cases with over 8.2 million patients discharged till date, as per the official government data.