Johnson & Johnson Pulls Application For Accelerated Approval Of COVID-19 Shot In India: Report

  • Johnson & Johnson (NYSE: JNJ) has withdrawn its application seeking accelerated approval of its COVID-19 vaccine, drugs regulator Drugs Controller General of India informed.

  • 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.

  • Related: Pfizer Hits Deadlock With India Over Vaccine Indemnity Issue.

  • Earlier, it was reported that obstacles in importing the doses delayed the availability of the JNJ COVID-19 vaccine.

  • So far, four vaccines have been given Emergency Use Authorization (EUA) in India - AstraZeneca plc's (NASDAQ: AZN) Covishield, Indigenous Covaxin, Sputnik V from Russia, and Moderna Inc (NASDAQ: MRNA).

  • Price Action: JNJ shares closed at $172.20 on Friday.

  • Photo by Johaehn from Pixabay

See more from Benzinga

© 2021 Benzinga does not provide investment advice. All rights reserved.