Subscribe to our Newsletters !!
Infections pose an everpresent threat to society a
Biotech Fluidics has introduced a durable dual sta
A new COVID-19 variant, BA.3.2, informally called
The sustained tensions between Iran and the United
For a number of years now, healthcare systems glob
Tofu used to be associated with Asian cuisine, but
Dear Readers, Welcome to a fresh and forward-lo
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.
“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.
