J&J seeks nod for vaccine trials on 12-17 year-olds

Pharma major’s single shot candidate was granted emergency use approval

U.S. pharma major Johnson & Johnson (J&J) has applied for permission to conduct clinical trials of its single-shot COVID-19 vaccine on adolescents aged 12-17 years in India. The company has moved an application to the Central Drugs Standard Control Organisation (CDSCO) seeking approval.

J&J India spokesperson in a statement said: “We are committed to facilitating global equitable access to its COVID-19 vaccine and recognise the unmet needs of children. On August 17, 2021, we submitted an application to the CDSCO to conduct a study of the J & J COVID-19 vaccine in India in adolescents aged 12–17 years.

“To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our COVID-19 vaccine equitably accessible for all age groups,” said the statement.

Previously in August, J&J’s single-dose COVID-19 vaccine had been granted emergency use approval (EUA) in India, and the Health Ministry has said it was in talks to get the vaccine available to the general public as soon as possible.

The five COVID vaccines granted EUA in India are Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna and now Johnson & Johnson (J&J). Coronavirus vaccine developed by J&J has demonstrated 85% efficacy in staving off severe COVID-19 disease in its phase 3 trials.

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