Johnson & Johnson’s single-dose vaccine approved in India for emergency use


The global healthcare major Johnson & Johnson announced on August 6, 2021, that it has applied for the Emergency Use Authorization (EUA) of its single-dose Coronavirus vaccine in India.

Earlier, the company had mentioned that it remained committed to bringing its single-dose vaccine to India and also looks forward to the ongoing discussions with the Government of India.

Johnson& Johnson in an official statement stated that the company looks forward to concluding its discussion with the Indian Government in order to accelerate the availability of its single-dose vaccine to help the pandemic.

Johnson & Johnson collaborates with Biological E:

A spokesperson of Johnson & Johnson said in a statement that on August 5, 2021, the company has applied for the Emergency Use Authorization of its single-dose COVID-19 vaccine to the Indian Government.

The statement further added that this will be an important milestone that will pave 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 Hyderabad-based Biological E Limited.

Biological E will be a significant part of Johnson & Johnson’s global supply chain network, helping to supply the COVID-19 vaccine through the extensive collaborations and partnerships that the company has with governments, health authorities, and organisations such as the COVAX facility and GAVI.

EUA submission in India:

The Emergency Use Authorization submission is based on the topline efficacy and safety data from the phase 3 ENSEMBLE clinical trial. It demonstrated that the company’s single-shot vaccine was 85% effective in preventing severe disease across all the regions studied.

The trial showed the protection against the COVID-19 related deaths and hospitalization, beginning 28 days after the vaccination.

COVID-19 cases in India:

According to the Health Ministry on August 6, 2021, the country recorded 44,643 new COVID-19 cases, taking the total tally to 3,18,56,757, while the active COVID cases registered an increase for the third consecutive day.

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