HYDERABAD: A day ahead of Bharat Biotech’s pre-submission meeting with the World Health Organisation (WHO) for emergency use listing (EUL) for Covaxin, the subject expert committee (SEC) has given its nod to the vaccine’s phase-3 efficacy trials data.
The inactivated SARSCoV-2 vaccine, developed by Bharat Biotech and Indian Council of Medical Research (ICMR), is learnt to have shown an efficacy of 77.8% as per the data submitted to the Central Drugs Standard Control Organisation (CDSCO).
The SEC, which advises the Drugs Controller General of India (DCGI), 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.
The Hyderabad-based vaccine maker will also be carrying out a phase-4 clinical trial of Covaxin to check its real world efficacy, as it had indicated recently.
The company had been facing a lot of heat for the delays in making public the final phase-3 data of Covaxin, which has been mired in controversy since its restricted emergency use authorisation on January 3 while its phase-3 trials were underway.
Bharat Biotech’s top brass had attributed the delays in declaring the data to it being the largest efficacy trial conducted in the developing world, generating reams of data that was taking time to process.
The phase-3 study was conducted on 25,800 volunteers in the 18-99 years age bracket.
While the company had declared an interim efficacy of 81% after the first analysis in March, it had in April declared an overall interim efficacy of 78% and a 100% efficacy against severe Covid-19 disease and hospitalisation.