Bharat Biotech’s COVID-19 vaccine has been approved for human trials, making it India’s first domestic candidate to get the green light from the government’s drug regulator as cases surge in a country with more than 1.3 billion people.
The Drug Controller General of India has approved the company’s application to conduct a Phase I and II clinical trial of Covaxin, which was developed along with the Indian Council of Medical Research’s National Institute of Virology, the company said in a statement on Monday.
Human clinical trials are scheduled to start across the country in July for the vaccine, which was developed and manufactured in Bharat Biotech’s facility at Genome Valley in Hyderabad, India.
India, which lags only the United States, Brazil and Russia in total cases, reported close to 20,000 new infections on Monday, according to data from the country’s federal Ministry of Health.
More than 16,000 people have died from the disease since the first case in India in January – low when compared with countries with similar numbers of cases.
But experts fear hospitals in the densely populated nation will be unable to cope with a steep rise in cases.
No vaccine has yet been approved for commercial use against the illness caused by the new coronavirus, but over a dozen vaccines from more than 100 candidates globally are being tested on humans.
China’s military received the approval to use a COVID-19 vaccine candidate developed by its research unit and CanSino Biologics after clinical trials proved it was safe and showed some efficacy, the company said on Monday.