Covaxin: SEC under DGCI clears phase 3 trial data, shows 77.8% efficiency
text_fields
New Delhi:The Subject Expert Committee under the Drug Controller General of India has cleared the Phase -3 trial data of Bharat Biotech's Covaxin on Tuesday.
As per the data from Phase III trials conducted on 25,800 participants across the country, Covaxin is found to be 77.8 per cent effective in against COVID-19 virus, said sources.
The data and information regarding phase 3 trials were presented to the Drug Controller General of India (DCGI) over the weekend.
Earlier in March, the "first interim analysis" of Phase III results,had shown 81 per cent efficiency for Covaxin in preventing COVID-19 in those without prior infection after the second dose.
Meanwhile, Bharat Biotech said it is planning to conductphase 4 trials to check the "real-world effectiveness of the vaccines" and to meet scientifically approved standards for safety and vaccine efficacy.
The company will also hold a 'pre-submission' meeting on Wednesday with the World Health Organisation, regarding the approval of Covaxin.
