India says J&J withdraws proposal for speedy vaccine approval

Reuters2021-08-02

(Adds details, background)

BENGALURU, Aug 2 (Reuters) - 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.

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.

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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Comments

snb
2021-08-02
snb
Sad
FCY
2021-08-02
FCY
Why still negotiating with the vaccine makers when the covid is still rampant in india?
Soojj
2021-08-02
Soojj
Wow
- Soojj:
  Ok
tyng8825
2021-08-02
tyng8825
Good
- domobc:
  like pleaze
tyng8825
2021-08-02
tyng8825
Good
- JackOATrades:
  ok

Leave a comment

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