Global pharmaceutical giant Johnson & Johnson applied for Emergency Use Authorisation (EUA) of single-dose COVID vaccine in India, the company said in a statement, on Friday. This comes after the company, earlier this week, said that it stands committed to bringing its single-dose COVID-19 vaccine to India.

“On August 5, 2021 Johnson & Johnson Pvt Ltd applied for EUA of its single-dose COVID-19 vaccine to the government of India,” a Johnson & Johnson India spokesperson said in a statement.

“This is an important milestone that paves the way for bringing the company’s single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited,” the statement added.

“Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson COVID-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility,” the statement read.

As per the statement, the EUA submission is backed by a topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial. It demonstrated the company’s single-shot vaccine was 85% effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination.

“We look forward to concluding our discussions with the government of India to accelerate availability of our COVID-19 vaccine to help end the pandemic,” the statement said.

India, on Friday, reported 44,643 new coronavirus infections taking the total tally of COVID-19 cases to 31,856,757, while the active cases registered an increase for the third consecutive day, the Union Health Ministry data showed. The death toll climbed to 426,754 with 464 fresh fatalities.

Johnson & Johnson’s vaccine was given emergency use authorisation by the US FDA in February 2021.

After this, the European Centre for Disease Prevention and Control (ECDC) found a rare nerve nerve-degenerating disorder as one of the side-effects of the vaccine.

So far, two vaccines — COVISHIELD and indigenously developed COVAXIN — are being used in India. Meanwhile, a third vaccine Sputnik V, developed in Russia, received approval from the Indian drug regulator.