New Delhi: Global healthcare major Johnson & Johnson on Friday stated it has requested for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine in India.
On Monday, the company had mentioned that it remained committed to bringing its single-dose COVID-19 vaccine to India and looks forward to proceeding discussions with the Indian government.
“On August 5, 2021 Johnson & Johnson Pvt Ltd requested for EUA of its single-dose COVID-19 antibody from the government of India,” a Johnson & Johnson India representative said in a statement.
This is an crucial milestone that shows the way for bringing the company’s single-dose COVID-19 vaccine to the citizens of India, and the rest of the planet, through an association with Biological E Limited, the statement added.
“Biological E will be a crucial part of our global supply chain network, aiding to supply our Johnson & Johnson COVID-19 vaccine through the extensive cooperation and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility,” the statement said.
The EUA compliance is based on topline efficacy and safety report from the Phase 3 ENSEMBLE clinical tests, which illustrate that company’s single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and indicatec protection against COVID-19 related hospitalisation and death, starting 28 days after vaccination, it added.
“We look forward to settling our discussions with the government of India to ramp up availability of our COVID-19 vaccine to help conclude the pandemic,” the statement said.
India detailed 44,643 new coronavirus diseases taking the total tally of COVID-19 cases to 3,18,56,757, while the active cases logged an increase for the third consecutive day, according to the Union Health Ministry report updated on Friday. The casualty toll reached 4,26,754 with 464 fresh mortalities.
