Johnson and Johnson’s single-dose Covid-19 vaccine gets approval for emergency use in India: Health minister

Vials and syringes of the Johnson and Johnson Janssen Covid-19 vaccine. Pic/AFP

Global healthcare major Johnson and Johnson's single-dose Covid-19 vaccine gets approval for emergency use in India, Union Health Minister Mansukh Mandaviya tweeted on Saturday.

Johnson and Johnson on Friday had applied for Emergency Use Authorization (EUA) of its single-dose vaccine against novel Coronavirus in India and was granted the approval the same day by the Drugs Controller General of India (DCGI). The company, in a statement, had said that it will bring the vaccine through a collaboration with Hyderabad-based Biological E. Limited.

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

"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)," a senior official said.

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.

However, on July 29, the firm withdrew its proposal.

A health ministry official at a recent press conference had clarified that J&J earlier applied for conducting phase-3 clinical trial of its vaccine.

"The application was to undertake clinical trial and when we issued relaxed guidelines in which we said if you had approval from other regulatory bodies of other countries, then exemption would be given from clinical trials, and emergency use authorisation would be granted and trial could be continued later on, so now since they did not need it they withdrew that application," the official had said.

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.

(With agency inputs)