Salem Radio Network News Monday, September 20, 2021

Health

India says J&J withdraws proposal for speedy vaccine approval

BENGALURU (Reuters) -India’s drug regulator said https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=MTQyNA== 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 https://www.reuters.com/world/india/jj-seeks-approval-conduct-trial-its-covid-19-vaccine-india-2021-04-20 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. https://www.reuters.com/world/india/legal-wrangles-hold-up-us-vaccine-donations-india-2021-07-28

Johnson & Johnson and the Central Drugs Standard Control Organisation (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 authorisation to Moderna’s vaccine in June.

(Reporting by Shivani Singh in Bengaluru; editing by Uttaresh.V)

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