J&J withdraws plea to hold vaccine trials as govt relaxes norms

NEW DELHI: Johnson & Johnson has withdrawn its application seeking permission to conduct clinical trials in India for its single-shot Covid-19 vaccine as under the revised policy it can seek an accelerated approval for emergency use and do clinical trials later, an official said. “J&J is yet to submit an application seeking emergency use authorisation,” the official said.
J&J had sought approval in April to conduct a bridging clinical study of its vaccine candidate in India. With an aim to increase availability of jabs and enable faster access to foreign-made Covid vaccines, the government had done away with bridging trial studies prior to grant of emergency authorisation for shots approved by recognised regulators like US FDA or UK’s MHRA.