Bharat Biotech's Covaxin approved in 'clinical trial mode': Health ministry

The Subject Expert Committee of the Central Drugs Standard Control Organisation on Saturday recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID-19 vaccine Covaxin in India, PTI reported.

The move came a day after the panel recommended granting permission for restricted emergency use of Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India, paving the way for the roll-out of the first COVID-19 shot in the country in the next few days.

The SEC had earlier asked Bharat Biotech to expedite volunteer recruitment for the ongoing phase 3 clinical trial and recommended that it might conduct interim efficacy analysis for further consideration of restricted emergency use approval for the vaccine.

The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from the Serum Institute of India (SII) and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.

Considering Bharat Biotech's application, the SEC had also noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated.

While granting the restricted emergency use approval for the Oxford COVID-19 vaccine, the panel had imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of four to six weeks.