New Delhi, Aug 07: US pharma major Johnson & Johnson’s single-dose COVID-19 vaccine has received emergency use approval in India.
“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,” tweeted Union Health Minister Mansukh Mandaviya.
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 #COVID19
— Mansukh Mandaviya (@mansukhmandviya) August 7, 2021
“We are pleased to announce that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID19 single-dose vaccine in India, to prevent COVID in individuals 18 years of age and older,” said Johnson & Johnson India spokesperson.
Earlier on Monday, 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 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, it added.
“We look forward to concluding our discussions with the government of India to accelerate availability of our COVID-19 vaccine to help end the pandemic,” the statement said.
With Johnson and Johnson approval, India now has five Covid vaccines which have been given emergency use approval. Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna have got approval in India.
In a bid to fast-track emergency approvals for all foreign produced coronavirus jabs, the central government had announced that COVID-19 vaccines which were approved for restricted use by regulators in the US, UK, Europe and Japan, or which were on the World Health Organisation’s Emergency Use Listing, would not have to conduct bridging clinical trials in India.