J&J applies for EUA of COVID-19 vaccine in India
(Sourced from PTI)
Global healthcare major Johnson & Johnson on Friday said that it has applied for Emergency Use Authorization (EUA) 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 regarding this.
"This is an important milestone that paves the way for bringing the company's single-dose vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited," a Johnson & Johnson India spokesperson said in a statement. "Biological E will be an important part of our global supply chain network," the statement said.
"Biological E will help to supply our Johnson & Johnson COVID-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities, and organizations 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," the statement further added.
"The Phase 3 ENSEMBLE clinical trial demonstrated that the company's single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization 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," the statement said.
India recorded 44,643 new coronavirus infections taking the total tally of COVID-19 cases to 3,18,56,757, while active cases registered an increase for the third consecutive day, according to Union Health Ministry data updated on Friday. The death toll climbed to 4,26,754 with 464 fresh fatalities.
