J&J Seeks India's Permission For Phase 3 Trial Of 1-Shot Vaccine: Report

Johnson & Johnson's vaccine is a single-dose jab, whereas the three vaccines cleared by India so far are of doubles doses.

Multinational pharma giant Johnson & Johnson has applied to India's drug regulator seeking permission to conduct phase-3 clinical trial of its single-dose COVID-19 vaccine in India as well as import licence, sources said. They said the company has sought an early meeting of the subject expert committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) to take a decision on its application. This comes close to the heels of the central government last week deciding to fast-track emergency approvals for all foreign produced coronavirus jabs that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan. Such vaccines will be given emergency use approval mandating the requirement of post-approval parallel bridging clinical trial in place of conduct of local clinical trial under the provisions of the New Drugs and Clinical Trials Rules 2019, the health ministry had said.