Serum Institute has knocked on the drug controller's door seeking an emergency use authorisation for Covishield, the vaccine it’s developing in collaboration with AstraZeneca and Oxford University. This comes, days after Pfizer's India arm sought a similar approval. However, the US Pharma giant does not want to conduct bridge trials in India and has asked the regulator for a waiver.
Dr. Shahid Jameel, Senior Virologist, Director at Ashoka University, spoke to CNBC-TV18 about the same.
On bridge trail, he said, “It is entirely choice of the regulator, in this case the Drugs Controller General of India (DCGI) to grant approval without a bridge trial or not. My understanding is that the waiver for bridge trial is sort on the basis of an unmet need which is fine. But do we have all the pieces in place to decide how we are going to roll out this vaccine.”
“Let us say the regulator gives us approval without a bridge trail for this vaccine, do we have a plan ready to roll it out in the next two weeks. I am little confused with the Pfizer announcement simply because Pfizer has also said that they will not sell without government contracts so does this mean Pfizer will sell only to the government. I mean this is a vaccine that can easily come into the private market.”Watch this video for more.