Johnson & Johnson’s single-dose COVID-19 vaccine has been given Emergency Use approval in India.
“India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is approved for Emergency Use in India. Now India has 5 EUA vaccines,” said Health Minister Mansukh Mandaviya on August 7.
The US-based pharmaceutical company had applied for Emergency Use Authorisation for its jab on Friday. It was granted the same day by the Drugs Controller General of India (DCGI), reported news agency PTI citing a senior official.
J&J earlier had sought approval to conduct a 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 and reactogenicity immunogenicity of the jab in healthy Indian adults. However, on July 29, the firm withdrew its proposal.
At a recent press conference, a health ministry official clarified that J&J earlier applied for conducting a 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 the exemption would be given from clinical trials, and emergency use authorization would be granted, and the 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 Johnson and Johnson’s COVID-19 vaccine, five vaccines have been granted Emergency Use Authorisation in India. The other four are Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, and Moderna.