J&J seeks Indian regulator’s nod for COVID vaccine trials on adolescents

Johnson & Johnson (J&J) last week said it has submitted an application to the Indian drug regulator to conduct a study of its COVID-19 vaccine in adolescents aged 12-17 years. The US-based pharmaceutical company noted that it is committed to facilitating global equitable access to its COVID-19 vaccine, and recognises the unmet needs of children.

“On August 17, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson COVID-19 vaccine in India in adolescents aged 12-17 years,” a J&J India spokesperson said in a statement.

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

Earlier this month, the government had given Emergency Use approval to J&J’s single-dose COVID vaccine in India. While announcing the approval, health minister Mansukh Mandaviya had said the approval would further boost the country’s collective fight against the novel coronavirus infection.

The five vaccines granted Emergency Use Authorisation in India are Covishield, Covaxin, Sputnik V, Moderna and J&J.

Edited by EP Bureau