Whereas the US-based prescription drugs firm had sought approval for conducting bridging trials right here, it says it would not have to do this now since India has scrapped that requirement. The corporate mentioned it’s exploring find out how to speed up the supply of its vaccine in India.
The Medicine Controller Common of India not too long ago introduced that Covid-19 vaccines which had been accredited for restricted use by regulators within the US, UK, Europe and Japan, or which had been on the World Well being Group’s Emergency Use Itemizing, would not should undergo bridging medical trials in India.
“Thus, the requirement for Johnson & Johnson to conduct a bridging medical examine of our single-dose Janssen Covid-19 vaccine candidate not exists,” the spokesperson mentioned. J&J had approached India’s drug regulator for conducting a bridging trial even after India relaxed the regulatory necessities for imported vaccines. It’s unclear why J&J sought this clearance.
“The corporate went forward looking for approval to conduct a bridging trial and had not requested for a waiver as it’s entitled to beneath the relaxed regulatory regime that was put in place in April,” mentioned a authorities official.