Paul additionally mentioned that Bharat Biotech is anticipated to publish Phase 3 medical trials information in about 7-8 days. “It (US FDA’s choice) has no impression in any way on our programme.
“Our regulator has approved it. We have so much data on safety, we have so much data from Phase 3 that has been screened, seen by our own regulator,” he said.
Dr Paul, who heads the expert group in vaccine administration, said the Phase 3 data to be published is beyond what has been shared so far with the DCGI (Drugs Controller General of India) based on which BB received the licensure.
He said every regulator has its own mechanism and the nuances of scientific considerations may differ. “Every country has a regulatory system and some things might be common, others may differ. They (US FDA) have their own parameters and we respect that. Similarly, our regulatory system also takes decisions. Scientific framework is same, but nuancing is according to context,” Dr Paul said.
“Scientific considerations are there… some differences may be there, especially in those countries where science is strong and for us manufacturing is strong. So, they have taken this decision and we respect it. We expect that our manufacturer will be able to comply with it by doing whatever needs to be done (to fulfil licence conditions),” he said. The FDA’s call will delay the launch of Covaxin in the US as the regulator has “recommended” Ocugen Inc, the US partner of the Indian vaccine-maker, to go for Biologics Licence Application route with additional data. While Covaxin is yet to be recognised by the WHO, the government said there has been a slight delay in it but the process is on.