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It is yet to be clear the reason for the withdrawal of the application. JNJ had said in April that it was seeking approval to conduct a bridging clinical study of its Janssen COVID-19 vaccine candidate in India. Trials in the U.S. at that time were paused on reports of rare blood clots. The withdrawal comes as India tackles legal challenges with manufacturers over indemnity issues.
Since the Drugs Controller General of India (DCGI) recently directed that there is no longer a requirement to conduct bridging clinical studies of Covid-19 vaccines in India, Johnson & Johnson withdrew its application to conduct these studies.