J&J single-dose COVID-19 vaccine gets emergency use approval in India 

Indian government has given Johnson and Johnson’s single-dose COVID-19 vaccine approval for emergency use in the country, said Union Health Minister Mansukh Mandaviya in a tweet on Saturday. 

The vaccine joins the likes of Covishield, Covaxin, Moderna and Sputnik V vaccines, which have got the emergency use approval in the country till now.   

On the microblogging site, Mandaviya said, “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.” 

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

Earlier, Global healthcare major Johnson & Johnson had said it applied for Emergency Use Authorisation (EUA) of its single-dose COVID-19 vaccine in India. 

The company had said that it remained committed to bringing its single-dose COVID-19 vaccine to India and looks forward to ongoing discussions with the Indian government. 

"On August 5, 2021 Johnson & Johnson Pvt Ltd applied for EUA of its single-dose COVID-19 vaccine to the government of India," a Johnson & Johnson India spokesperson said in a statement. 

This is an important milestone that paves the way for bringing the company's single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited, the statement added. 

"Biological E will be an important part of our global supply chain network, helping to supply our Johnson & Johnson COVID-19 vaccine through the extensive collaborations and partnerships we have with governments, health authorities and organisations such as Gavi and the COVAX Facility," the statement said. 

The EUA submission is based on topline efficacy and safety data from the Phase 3 clinical trial, which demonstrated that the 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, it added. 

"We look forward to concluding our discussions with the government of India to accelerate the availability of our COVID-19 vaccine to help end the pandemic," the statement said. 

(With inputs from agencies)