Johnson & Johnson Withdraws Speedy Covid Vaccine Approval Proposal In India: Report

Johnson & Johnson Withdraws Speedy Covid Vaccine Approval Proposal In India: Report

Johnson & Johnson Withdraws Speedy Covid Vaccine Approval Proposal In India: Report

Johnson & Johnson withdrew proposal looking for accelerated approval in India, a report mentioned.

Bengaluru:

India’s drug regulator mentioned on Monday that Johnson & Johnson withdrew its proposal looking for accelerated approval of its COVID-19 vaccine within the nation, with out giving further particulars, based on a report by information company Reuters.

The US primarily based firm had mentioned in April it was looking for an approval to conduct a bridging medical examine of its Janssen COVID-19 vaccine candidate in India. Trials within the United States at the moment have been paused on studies of uncommon blood clots.

The drugmaker’s withdrawal comes as India tackles authorized challenges with producers over indemnity points, with its junior well being minister saying final week {that a} staff had been shaped to have interaction with vaccine makers.

“This staff is in steady dialogue with Pfizer, Moderna and Johnson & Johnson to debate and deal with numerous points together with the problem of indemnity,” Bharati Pravin Pawar had mentioned, based on information company Reuters.

Johnson & Johnson and the Central Drugs Standard Control Organization (CDSCO) didn’t instantly reply to Reuters’ requests for feedback on why the corporate withdrew its utility.

As of July 31, Johnson & Johnson is but to request a full approval for its shot with the US FDA, whereas Pfizer Inc, BioNTech SE, and Moderna Inc have already sought full approval of their vaccines with the FDA.

In India, the drug regulator had given emergency use authorization to Moderna’s vaccine in June.

(Except for the headline, this story has not been edited by NDTV workers and is printed from a syndicated feed.)

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