In India, Johnson & Johnson is seeking approval for a single-dose Covid vaccination study on teenagers.
Johnson & Johnson (J&J) has filed an application with the Central Drugs Standard Control Organisation (CDSCO) to undertake a trial of the COVID-19 single shot Janssen vaccine in adolescents aged 12 to 17 years in India, according to the firm.
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.”
