Johnson & Johnson Withdraws Proposal for Speedy Covid Vaccine Approval in India
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New Delhi : The Central Drugs Standard Control Organisation said on Monday that Johnson & Johnson withdrew its proposal seeking accelerated approval of its COVID-19 vaccine in the country, without giving additional details.The US-based company had said in April it was seeking an approval to conduct a bridging clinical study of its Janssen COVID-19 vaccine candidate in India. Trials in the United States at that time were paused on reports of rare blood clots.The drugmaker's withdrawal comes as India tackles legal challenges with manufacturers over indemnity issues, with its junior health minister saying last week that a team had been formed to engage with vaccine makers."This team is in continuous dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and address various issues including the issue of indemnity," BharatiPravinPawar had said.As of July 31, Johnson & Johnson is yet to request a full approval for its shot with the U.S. FDA, while Pfizer Inc, BioNTech SE, and ModernaInc have already sought full approval of their vaccines with the FDA.
