Indian Covid-vaccine basket has expanded with the single dose Covid-19 vaccine Janssen, manufactured by US pharma giant Johnson and Johnson, becoming the fifth jab to get Emergency Use Authorisation (EUA) by the Government on Friday. The four other Covid-19 vaccines already approved by the Government are Covishield, Covaxin, Sputnik V and Moderna.
“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,” Union Health Minister Mansuk Mandaviya tweeted.
J&J had applied for EUA for its jab on Friday and was granted the approval the same day by the Drugs Controller General of India (DCGI).
“We are pleased to announce that on August 7, 2021, the Government of India issued 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.
In a bid to fast-track emergency approvals for all foreign-produced coronavirus jabs, the 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 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 said in a statement, “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.”
Presently, Covishield leads the race in providing the number of vaccines shot to the people followed by Covaxin and Sputnik. India has crossed a significant milestone of administering 50 crore vaccine doses under a nationwide vaccination drive.