J&J’s single-dose Covid vaccine given approval for emergency use in India


US pharma giant Johnson and Johnson single dose Covid-19 vaccine Janssen became the fifth vaccine to gets Emergency Use Approval(EUA) by the government of India.

Health Minister Mansuk Mandaviya tweeted,”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 on Friday said it has applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine Janssen to the Government of India.”

This will be the fifth Covid-19 vaccine to get approval after Covishield, Covaxin, Sputnik V and Moderna in India.

“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,” said Johnson & Johnson India spokesperson as quoted by news agency ANI.

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.

The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI).

The pharma company stated that it is an important milestone that paves the way to bringing the single-dose COVID-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E. Limited.

It further stated that Biological E will be an important part of Johnson and Johnson’s global supply chain network, helping to supply its COVID-19 vaccine Janssen through extensive collaborations and partnerships with governments, health authorities and organisations such as Gavi and the COVAX Facility.

The pharma company’s statement read, “The EUA submission is based on topline efficacy and safety data from the Phase 3 clinical trial ENSEMBLE, 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 hospitalization and death, beginning 28 days after vaccination.”

India crossed a significant milestone of administering 50 crore vaccine doses under a nationwide vaccination drive.

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