New Delhi: The requirement to conduct a bridging clinical study of its single-dose Janssen Covid-19 vaccine no longer exists in India, pharmaceutical company Johnson & Johnson has said.
The US-based company said it was following the recent announcement by the Drug Controller General of India (DCGI) that there was no longer any requirement for conducting post-approval bridging clinical trials for Covid-19 vaccines in India.
The approval from DGCI is not required for covid vaccines restricted to use in case those are already approved for restricted use by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) Japan or listed in WHO Emergency Use Listing (EUL).
Johnson & Johnson said it remains fully focused on “bringing a safe and effective Covid-19 vaccine to people in India”.
“We are in ongoing discussions with the Government of India and are exploring how best to accelerate our ability to deliver our Covid-19 vaccine to India,” the pharmaceutical company added.