Johnson & Johnson seeks EUA for its single-dose COVID-19 vaccine in India

On Monday, before this initial statement, the company had proclaimed its commitment and tireless efforts towards bringing forth its single-dose COVID-19 vaccine to India and is eagerly awaiting its turn for negotiations with the Indian government.

Eminent Global healthcare enterprise, Johnson & Johnson on Friday announced that it had availed for an Emergency Use Authorization (EUA) of its single-dose jab of COVID-19 vaccine in India. On Monday, before this initial statement, the company had proclaimed its commitment and tireless efforts towards bringing forth its single-dose COVID-19 vaccine to India and is eagerly awaiting its turn for negotiations with the Indian government.

“On August 5, 2021, Johnson & Johnson Pvt Ltd applied for EUA of its single-dose COVID-19 vaccine to the government of India,” a Johnson & Johnson India spokesperson asserted 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 representative added.

The statement also added a crucial note that, “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 that the company’s 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 the availability of our COVID-19 vaccine to help end the pandemic,” added the spokesperson on a note.

Adhering to the official data displayed by the Union Health Ministry, India has recorded about fresh 44,643 infected cases, echoing the total tally of COVID cases to 3,18,56,757. The death toll went on a flying high of 4,26,754 with 464 newly reported fatalities.