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Johnson & Johnson’s single-dose Covid vaccine approved in India for emergency use

The Centre has granted approval to US drug maker Johnson & Johnson’s single-dose Covid-19 vaccine for emergency use in India, Union Health Minister Mansukh Mandaviya said.

Johnson & Johnson’s single-dose COVID-19 vaccine has been given Emergency Use approval in India, Union Health minister Mansukh Mandaviya tweeted saying ‘this will further boost the country’s collective fight against the novel coronavirus infection,’ on Saturday.

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 five vaccines granted Emergency Use Authorisation in India are Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna and now Johnson & Johnson.

J&J earlier had sought approval to conduct phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups—those aged 18 and below 60 years and those aged 60 years and above—to evaluate the safety, reactogenicity and immunogenicity of the jab in healthy Indian adults.

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 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.

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