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Home >Companies >News >Johnson & Johnson seeks nod for trial of Covid vaccine on 12-17 year age group in India

US pharma giant Johnson & Johnson (J&J) has moved an application to the Central Drugs Standard Control Organisation (CDSCO) seeking permission to conduct a study of the COVID-19 single shot Janssen vaccine in India in adolescents aged 12 – 17 years, the company said.

Conducting vaccine clinical trials among adolescents is imperative to achieve herd immunity against the coronavirus, J&J said in an emailed statement.

J&J has a supply agreement with Indian vaccine maker Biological E Ltd to bring its shot to the country

 

The single-shot vaccine, developed by J&J shown to be 85 per cent efficacy in preventing severe disease in Phase 3 human clinical trials.

Earlier in August, J&J informed had applied for Emergency Use Authorization (EUA) of its single-dose COVID-19 vaccine Janssen in India.

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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