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J&J applies for EUA of its COVID-19 vaccine in India

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TIMESOFINDIA.COM    07 August 2021

Johnson & Johnson has sought Emergency Use Authorization (EUA) of its single-dose COVID vaccine in India, said the company on Friday.

The company’s India spokesperson said that the company applied for EUA on August 5, 2021 for its single-dose COVID-19 vaccine to the Government of India.

A statement by the company said that this is a major milestone that will enable bringing the single-dose vaccine to India, and the rest of the world, by collaborating with Biological E Limited.

It said that Biological E will play a significant role in the vaccine’s global supply chain network, and assist with the supply of the vaccine through extensive collaborations and partnerships with governments, health authorities and organizations like Gavi and the Covax Facility.

The EUA submission is based on data obtained from the Phase 3 ENSEMBLE clinical trial, which showed that the vaccine was 85% effective in preventing severe disease, and protected against COVID-19 related hospitalization and death, starting 28 days following vaccination.

Source: ET Healthworld

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