[ad_1]
BENGALURU: India’s drug regulator said Monday that Johnson & Johnson was withdrawing its proposal to speed up approval of its Covid-19 vaccine in the country, without giving further details.
The US-based company said in April that it was seeking approval to conduct a transitional clinical study of its Janssen Covid-19 vaccine candidate in India. Trials in the United States around this time were suspended on reports of rare blood clots.
The drugmaker’s withdrawal comes as India grapples with legal issues with manufacturers over compensation concerns, with its junior health minister saying last week that a team has been formed to deal with it. engage with vaccine manufacturers.
“This team is in constant dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and resolve various issues, including the issue of compensation,” said Bharati Pravin Pawar.
Johnson & Johnson and the Central Drugs Standard Control Organization (CDSCO) did not immediately respond to requests for comment from Reuters on why the company withdrew its request.
As of July 31, Johnson & Johnson had yet to seek full vaccine approval from the US FDA, while Pfizer Inc, BioNTech SE and Moderna Inc had already requested full approval of their vaccines from the FDA. .
In India, the drug regulator gave an emergency use authorization for Moderna’s vaccine in June.
The US-based company said in April that it was seeking approval to conduct a transitional clinical study of its Janssen Covid-19 vaccine candidate in India. Trials in the United States around this time were suspended on reports of rare blood clots.
The drugmaker’s withdrawal comes as India grapples with legal issues with manufacturers over compensation concerns, with its junior health minister saying last week that a team has been formed to deal with it. engage with vaccine manufacturers.
“This team is in constant dialogue with Pfizer, Moderna and Johnson & Johnson to discuss and resolve various issues, including the issue of compensation,” said Bharati Pravin Pawar.
Johnson & Johnson and the Central Drugs Standard Control Organization (CDSCO) did not immediately respond to requests for comment from Reuters on why the company withdrew its request.
As of July 31, Johnson & Johnson had yet to seek full vaccine approval from the US FDA, while Pfizer Inc, BioNTech SE and Moderna Inc had already requested full approval of their vaccines from the FDA. .
In India, the drug regulator gave an emergency use authorization for Moderna’s vaccine in June.
[ad_2]
Source link