On 5th August 2021 Johnson & Johnson Pvt. Ltd applied for Emergency Use Authorization (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. 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 EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our 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.
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.