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Under the primary end-point, the SEC has asked the company to monitor adverse events closely, including Multisystem Inflammatory Syndrome in Children (MIS-C), post the first and the second vaccine dose for 42 days to three months.
Johnson & Johnson has applied for Emergency Use Authorization (EUA) of its single-dose Covid-19 vaccine in India. The company has said that it is committed to discussing with the Indian government on bringing its single-dose Covid-19 vaccine for EUA to the country.
“On August 5, 2021, Johnson & Johnson Pvt Ltd applied for EUA of its single-dose COVID-19 vaccine to the government of India,” as per Johnson & Johnson India spokesperson.
The Company has also said that Biological E will be an important part of their global supply chain network. It will help to supply Johnson & Johnson Covid-19 vaccine through extensive collaborations and partnerships with governments, health authorities and organisations such as Gavi and the COVAX Facility.
The EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial. The trial demonstrated that the company’s single-shot vaccine was 85% effective in preventing severe disease across all regions studied. It also showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination.
“We look forward to concluding our discussions with the government of India to accelerate availability of our COVID-19 vaccine to help end the pandemic,” the statement said.