Johnson & Johnson applies for approval of its single-dose Covid vaccine in India
06 Aug 2021 15:09:40
New Delhi, August 06: Johnson & Johnson, has now applied to the Central Drug Standard Control Organisation of India seeking emergency use approval of its single-shot vaccine. According to Johnson & Johnson India spokesperson, the company had on August 5 applied for the Emergency Use Authorisation of its single-dose vaccine with the Government of India.
Earlier, the company had applied for a trial but as the Centre has now done away with the provision of trial for reputed and recognised vaccines, the Centre asked the vaccine maker to directly apply for approval.
A statement issued by the company on Thursday read, "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. It further stated that Biological E will be an important part of Johnson and Johnson's global supply chain network, helping to supply its COVID-19 vaccine Janssen through extensive collaborations and partnerships with governments, health authorities, and organisations such as Gavi and the COVAX Facility.
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.
"We look forward to concluding our discussions with the Government of India to accelerate the availability of our COVID-19 vaccine to help end the pandemic," it added.
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