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HomeNews ReportsJohnson and Johnson’s single-dose Covid-19 vaccine granted emergency use approval in India

Johnson and Johnson’s single-dose Covid-19 vaccine granted emergency use approval in India

Phase 3 Ensemble clinical trial shows that the J&J single-dose vaccine is 85% effective in preventing severe Covid-19 disease across all regions studied

The Janssen COVID-19 vaccine has become the fifth vaccine against the pandemic to be granted emergency use approval. Union health minister Mansukh Mandaviya tweeted today to inform that the single-dose vaccine manufactured by American pharmaceutical giant Johnson & Johnson has been given approval for Emergency Use in India.

The development comes just two days after the company had applied for Emergency Use Authorization in India. The company had said in a statement, “On August 5, 2021 Johnson & Johnson Pvt Ltd applied for EUA of its single-dose Covid-19 vaccine to the government of India.” They had submitted the application based on topline efficacy and safety data from the Phase 3 Ensemble clinical trial.

The trial had shown that the single-dose vaccine is 85% effective in preventing severe Covid-19 disease across all regions studied. It had also shown protection against Covid-19 related hospitalisation and death, which begins 28 days after vaccination. Data from a clinical trial in South Africa also suggest that the vaccine is effective in preventing severe illness and death from the Delta and Beta variants of the coronavirus.

The company has tied up with Biological E for the supply of the vaccine in India. The vaccine will also be produced in India, at Biological E plant in Hyderabad. “Johnson & Johnson is working with Biological E. Limited on the manufacturing of the Johnson Covid-19 vaccine. We believe Biological E. will be an important part of our global Covid-19 vaccine supply network, where multiple manufacturing sites are involved in the production of our vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed”, an official statement released by Johnson and Johnson had earlier said.

The vaccine developed by Janssen Vaccines in Leiden, Netherlands, a subsidiary of J&J, is a viral vector vaccine. It is based on a human adenovirus that has been modified to contain the gene for making the spike protein of the virus that causes COVID-19. Responding to this spike protein, the immune system in the body produces antibodies that fights the virus.

The four vaccines that India has already approved are Covishield developed by Astra Zeneca and Oxford University, Covaxin developed by Bharat Biotech, Sputnik V developed in Russia and the vaccine developed by Moderna in the USA.

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Staff reporter at OpIndia

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