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Home>>India>>Johnson & Johnson’s single-dose COVID-19 vaccine gets emergency use nod in India
India

Johnson & Johnson’s single-dose COVID-19 vaccine gets emergency use nod in India

international media news
August 8, 2021 285 Views0

Johnson & Johnson’s single-dose COVID-19 vaccine has been given approval for emergency use in India, Union Health Minister Mansukh Mandviya said on Saturday.

Announcing the news on Twitter, the Union Health Minister said India now has five emergency use authorization (EUA) vaccines, adding that this will further boost nation’s collective fight against coromnavirus.

“India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation’s collective fight against #COVID-19,” Mandviya said in a tweet.

In a statement, Johnson & Johnson India said this was an important step forward in accelerating the availability of its COVID-19 vaccine to help end the pandemic.

“We are pleased to announce that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India, to prevent COVID in individuals 18 years of age and older,”Johnson & Johnson India spokesperson said.

“This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our 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,” the spokesperson added.

The global healthcare major had on Friday said that it had applied for EUA of its single-dose COVID-19 vaccine in India.

The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated that 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, a Johnson & Johnson India spokesperson had said in a statement.

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