India’s Central Drugs Standard Control Organisation has declined to accept Pfizer’s request for approval without a small local trial.
Pfizer Inc has withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech.
“Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement.
The Indian drug regulator confirmed that the request for approval without a local trial on the vaccine safety in the Indian population was declined. Minutes of the meeting released by the Subject Expert Committee denied “grant of permission for emergency use in the country at this stage.”
The committee noted that incidents of palsy, anaphylaxis, and other reactions have been reported, which are being investigated.
“As of now, the pre-condition for any vaccine to be implemented in India is that you have to do a bridging trial,” Vinod K. Paul, who heads a government panel on vaccine strategy, said in an interview.