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J&J Seeks Indian Drug Regulator's Nod For Phase 3 Trials Of Its Single-Dose COVID-19 Vaccine, Import License: Report

Swarajya Staff

Apr 20, 2021, 08:31 AM | Updated 08:31 AM IST

(A picture of vaccine vials from Johnson and Johnson)
(A picture of vaccine vials from Johnson and Johnson)

In a major positive development that could go on to boost vaccine availability in the country, United States (US) based pharmaceutical giant Johnson & Johnson (J&J) is said to have applied to the Indian drug regulator, seeking permission to conduct third phase trials of its single-dose COVID-19 vaccine in India and to secure an import licence, reports Economic Times.

The company has reportedly also sought an early meeting of the the Drug Controller General of India's (DCGI) subject expert committee (SEC) on COVID-19 to take up its application.

The development comes after the government had recently fast-tracked the emergency approvals for all foreign-produced vaccines that have been given a similar nod by the World Health Organization (WHO) or regulators in the United States (US), the United Kingdom (UK), Europe, or Japan.

If approved, J&J's vaccine will be the first single-dose vaccine in India, as the other three, Covishield, Covaxin and Sputnik V, which have been approved for administration so far are all two-dose vaccines.

The development also gains significance as it comes the very day when the government decided to expand the nationwide COVID-19 vaccination drive by allowing everyone above 18 years of age to be vaccinated from 1 May.

The government has also permitted the state governments, private hospitals and industrial establishments to procure the doses directly from manufacturers.


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