J&J applies for phase-3 vaccine trials and import permission in India
American pharma giant Johnson & Johnson has applied to India's drug regulator for permission to conduct a phase-3 human trial of its single-dose Covid-19 vaccine in the country and imports, 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 decide on its application.
Faced with a vaccine crunch, the Indian government had last week decided to fast-track emergency approvals for all foreign-produced coronavirus vaccines which have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain, and Japan.
Johnson & Johnson's vaccine is a single-dose jab while the three vaccines already cleared by India -- Covishield by Oxford-AstraZeneca, Covaxin by Bharat Biotech, and Russia's Sputnik V -- so far are administered in two doses.
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