India says J&J withdraws proposal for speedy vaccine approval | Inquirer News

India says J&J withdraws proposal for speedy vaccine approval

/ 05:24 PM August 02, 2021

johnson and johnson vaccine

Vials labelled “COVID-19 Coronavirus Vaccine” and syringe are seen in front of displayed Johnson&Johnson logo in this illustration taken, February 9, 2021. REUTERS FILE PHOTO

BENGALURU –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.

The U.S.-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.

ADVERTISEMENT

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.

FEATURED STORIES

“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.

Johnson & Johnson and the Central Drugs Standard Control Organization (CDSCO) did not immediately respond to Reuters’ requests for comments on why the company withdrew its application.

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 Moderna Inc have already sought full approval of their vaccines with the FDA.

In India, the drug regulator had given emergency use authorization to Moderna’s vaccine in June.

Your subscription could not be saved. Please try again.
Your subscription has been successful.

Subscribe to our daily newsletter

By providing an email address. I agree to the Terms of Use and acknowledge that I have read the Privacy Policy.

TAGS: Health, India

© Copyright 1997-2024 INQUIRER.net | All Rights Reserved

We use cookies to ensure you get the best experience on our website. By continuing, you are agreeing to our use of cookies. To find out more, please click this link.