Global healthcare company Johnson & Johnson has confirmed that it has applied for emergency use authorisation (EUA) of its single-dose COVID-19 vaccine in India.
The company in a statement released on Friday said that on August 5, Johnson & Johnson Pvt. Ltd applied for EUA of its single-dose COVID-19 vaccine to the government of India.
“This is an important milestone that paves the way to bringing our single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E. Limited,” it said.
“Biological E will be an important part of its global supply chain network, helping to supply 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 further noted that the EUA submission was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that the 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.
“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,” said the company.
