Johnson & Johnson
Johnson & Johnson seeks approval for trial of COVID vaccine on adolescents in India
New Delhi/IBNS: US pharma major Johnson & Johnson (J&J) has written to Central Drugs Standard Control Organisation's (CDSCO) seeking approval for the clinical trial of its COVID-19 single-shot Janssen vaccine among children aged 12 to 17 years.
J&J has signed a supply agreement with Indian vaccine manufacturer Biological E Ltd to make and distribute the vaccine in the country.
The single-shot J&J vaccine has shown 85 per cent efficacy in preventing severe disease in Phase 3 human clinical trials.
Earlier in August, J&J had applied for Emergency Use Authorization (EUA) for its single dose vaccine Janssen.
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."
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