Johnson & Johnson’s single-dose COVID-19 vaccine has been given Emergency Use approval in India, Union Health Minister Mansukh Mandaviya said on Saturday.
He said this will further boost the country’s collective fight against coronavirus infection.
“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 five EUA vaccines. This will further boost our nation’s collective fight against #COVID19,” the minister tweeted.
“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.
In a statement, Johnson & Johnson India said this was an important step forward in accelerating the availability of its COVID-19 vaccine to help end the pandemic.
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“We are pleased to announce that on 7th August 2021, the Government of India issued Emergency Use Authorisation (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India to prevent COVID-19 in individuals 18 years of age and older,” a company spokesperson said.
“This decision was based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, which demonstrated our single-shot vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19-related hospitalisation and death, beginning 28 days after vaccination,” the spokesperson added.
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).
J&J earlier had sought approval to conduct a phase-3 clinical trial of its vaccine on about 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 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 authorisation would be granted and a 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, the 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.
