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

Johnson & Johnson said in April it was seeking approval to conduct a bridging clinical study of its Janssen COVID-19 vaccine candidate in India.

India's drug regulator said on Monday that Johnson & Johnson withdrew its proposal seeking accelerated approval of its COVID-19 vaccine in the country, without giving additional details, according to a report by news agency Reuters. 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," Bharati Pravin Pawar had said, according to news agency Reuters.