A day ahead of Bharat Biotech’s pre-submission meeting with the World Health Organisation for emergency use listing for Covaxin, the subject expert committee has given its nod to the vaccine’s phase-3 efficacy trials data.
The inactivated SARS-CoV-2 vaccine, developed by Bharat Biotech and Indian Council of Medical Research, is learnt to have shown an efficacy of 77.8% as per the data submitted to the Central Drugs Standard Control Organisation. The SEC, which advises the Drugs Controller General of India, is reported to have given its approval to the efficacy data after a marathon meeting on Tuesday. This followed the submission of the efficacy trials data to the drug regulator over the weekend.
The next step would be an approval from the DCGI, following which the company would be applying for a full licensure for the vaccine, as Bharat Biotech had indicated earlier this month.