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

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

ndtv.com

The J&J vaccine can be stored for up to three months in a temperature between 2 and 8 degrees Celsius.

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.

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