Johnson & Johnson`s single-dose COVID-19 vaccine gets emergency use approval in India

Union Health Minister Mansukh Mandaviya took to his official Twitter account and wrote that India has `expanded its vaccine basket`.

New Delhi: Johnson & Johnson's single-dose COVID-19 vaccine has got approval for Emergency Use Authorisation (EUA) in India, the Union Health Minister Mansukh Mandaviya informed on Saturday (August 7, 2021). Mandaviya took to his official Twitter account and wrote that India has 'expanded 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," the Union Health Minister tweeted.

A Johnson & Johnson India spokesperson had informed that the American multinational company had applied for EUA of its single-dose COVID-19 vaccine to the government of India on August 5, 2021. The shot will be brought to India through a supply agreement with vaccine maker Biological E Ltd.

The pharma company's statement said that the EUA submission is based on topline efficacy and safety data from the Phase 3 clinical trial ENSEMBLE, which demonstrated their single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied.

The Phase 3 clinical trial also showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The Johnson & Johnson (J&J)/Janssen vaccine was listed for emergency use by World Health Organization (WHO) on March 12 this year and the vaccine has ALSO been authorized for use in Europe, the United States and other countries.

This is to be noted that India has so far approved the use of vaccines developed by AstraZeneca (Covishield), Bharat Biotech (Covaxin), Russia's Gamaleya Institute (Sputnik) and Moderna.

Johnson & Johnson's single-dose COVID-19 vaccine received the Emergency Use Authorisation a day after India's cumulative vaccination coverage crossed the 50 crore mark. On the achievement, Prime Minister Narendra Modi on Friday had said that India's fight against COVID-19 has 'received a strong impetus'.