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.
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.
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.