Hyderabad
Ocugen, Bharat Biotech's US partner for Covid vaccine Covaxin, on Wednesday said it has submitted Investigational New Drug Application (IND) to the US Food and Drug Administration to conduct clinical trials.
The development comes a day after the World Health Organisation sought more details from Bharat Biotech to consider its Covid vaccine Covaxin for Emergency Use Listing.
The US firm in a press release said the Phase 3 trial, proposed in the IND, is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the USA.
The US drug regulator earlier in June "recommended" Ocugen Inc, to go for Biologics Licence Application (BLA) route with additional data, instead of Emergency Use Authorisation (EUA).
The proposed trial can be to people who either have not been vaccinated for Covid or who already received two doses of an mRNA vaccine at least six months earlier in the USA.
