The Drugs Controller General of India's Subject Expert Committee (SEC) has approved Bharat Biotech' Phase 3 trial efficacy data after questions were raised over the delay in announcing results.
According to the data submitted, Covaxin has shown the efficacy of 77.8 per cent from the trial conducted on 25,800 subjects. The vaccine had earlier received emergency approval from the DCGI, and is one of the three vaccines approved for the mass use in India.
Hyderabad-based biotechnology company had earlier submitted phase-III clinical trial data of its COVID-19 vaccine Covaxin to the drug regulator. Trial data for phase-III is crucial as it will provide details of the efficacy of the vaccine, which was developed in association with the Indian Council of Medical Research (ICMR). Phase-III trial data is also required for getting emergency use listing (EUL) from the World Health Organisation (WHO).
The WHO has accepted Bharat Biotech's Expression of Interest (EoI) for EUL for Covaxin and scheduled a pre-submission meeting on June 23. The complete results of Covaxin's phase-III trial data will be made public during July.
In March, the vaccine maker had said Covaxin demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose. In January, DCGI had granted permission for emergency use of Covaxin based on its phase-I and phase-II clinical trial data.
Covaxin is supplied to the government at Rs 150 per dose, and the charges for administration of Covaxin across private hospitals has been fixed at Rs 1,410 per dose. The prices are based on the prices currently declared by vaccine manufacturers, and also include 5 per cent GST (Goods and Services Tax) charged on the vaccines.