India nod to J&J vaccine
New Delhi, Aug. 7: 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 the 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. “We are pleased to announce that on August 7,
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 per cent effective in preventing severe disease across all regions studied, and showed protection against Covid-19related 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 phase3 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.