Johnson & Johnson won’t be taking responsibility for the local trials for its single-shot COVID-19 vaccine in India. 

The US-based pharmaceuticals company had earlier was seeking approval for conducting bridging trials. But now as India has scrapped that requirement, it won’t conduct the trial. The company is exploring ways to hasten the availability of its vaccine in India.

The Drugs Controller General of India announced that vaccines approved for restricted use by regulators in the UK, US, Japan, Europe, and those on the WHO’s Emergency Use Listing, won’t be undergoing the bridging clinical trials in India. 

Their spokesperson said that the requirement for Johnson & Johnson to conduct a bridging clinical study of single-dose Janssen vaccine no longer exists. Earlier, the company had sought approval to conduct a bridging trial, however now did not ask for a waiver as it is eligible under the relaxed regulatory regime.

Source: ET Healthworld