Coronavirus update: Johnson & Johnson has applied for emergency use authorisation of its single-dose Covid 19 vaccine in India.
''On August 5, 2021, Johnson & Johnson Pvt Ltd applied for EUA of its single-dose coronavirus vaccine to the Government of India,'' a Johnson & Johnson India spokesperson said in a statement.
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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 the company's single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against coronavirus-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 the availability of our Covid 19 vaccine to help end the pandemic,'' the statement said.
Meanwhile, 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.