Global healthcare major Johnson & Johnson on Friday said it has applied for Emergency Use Authorization of its single-dose COVID-19 vaccine in India.
Earlier on Monday, the company had said that it remained committed to bringing its single-dose COVID-19 vaccine to India and looks forward to ongoing discussions with the Indian government.
"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 said.
The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that company's single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalisation and death, beginning 28 days after vaccination, it added.
"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 recorded 44,643 new coronavirus infections taking the total tally of COVID-19 cases to 3,18,56,757, while the active cases registered an increase for the third consecutive day, according to the Union health ministry data updated on Friday. The death toll climbed to 4,26,754 with 464 fresh fatalities.