Phase I, Phase II clinical trials were conducted in approximately 800 subjects by Bharat Biotech
Bharat Biotech has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters, DCGI said in a press release.
All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, approximately 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.