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India Approves Johnson & Johnson’s Covid-19 Vaccine for Emergency Use

US pharma giant Johnson and Johnson has got Emergency Use Authorization (EUA) of its single-dose Covid-19 vaccine Janssen from the Government of India, on Saturday.

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Johnson and Johnson Covid-19 Vaccine Jassen. (Source: J&J website)

New Delhi: US pharma giant Johnson and Johnson has got Emergency Use Authorization (EUA) of its single-dose Covid-19 vaccine Janssen from the Government of India, on Saturday. Johnson and Johnson became the fifth Covid-19 vaccine to have received regulatory approval from the Indian government. In India Bharat Biotech’s Covaxin, SII’s Covishield, Gamaleya’s Sputnik-V and Moderna’s Covid-19 vaccine have previously received EUA nod.

While the former two have been administered since January 16, 2021, when India began its national immunization programme against Covid-19, Sputnik and Moderna’s received their approvals later in April and June.

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J&J had applied for authorisation on Thursday and issued a statement that said, “On 5th August 2021 Johnson and Johnson Pvt. Ltd applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine to the Government of 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.

Biological E will be a part of Johnson and Johnson’s global supply chain network, and would help supply its COVID-19 vaccine Janssen through collaborations and partnerships with other governments, health authorities and organisations such as Gavi and the COVAX Facility, the company said.

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The pharma company’s statement read, “The EUA submission is based on topline efficacy and safety data from the Phase 3 clinical trial ENSEMBLE, which demonstrated our single-shot vaccine was 85 per cent effective in preventing severe disease across all regions studied, and showed protection against Covid-19 related hospitalization and death, beginning 28 days after vaccination.”

In its statement released on July 2, Johnson and Johnson said that its single-shot Covid-19 vaccine generated “strong, persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants”. In addition, the data showed that the durability of the immune response lasted through at least eight months, the company claimed.