Bharat Biotech recruits 23,000 volunteers for 3rd phase trial of Covaxin

Bharat Biotech on Saturday announced that it had successfully recruited 23,000 volunteers progressing towards achieving the goal of 26,000 participants for the Phase-3 clinical trial of its vaccine candidate COVAXIN across multiple sites in India. Issuing a statement, Bharat Biotech said that the Phase-3 human clinical trials of COVAXIN, which began mid-November, were targeted to be carried through 26,000 volunteers across India, making it India’s first and only Phase-3 efficacy study for COVID-19 vaccine. Moreover, it is also the largest Phase-3 efficacy trial ever conducted for any vaccine in India, as per the Pharma giant. 

Read: Bharat Biotech's Top Brass Calls On Vice President Naidu

Read: India's Vaccine Covaxin By Bharat Biotech Draws Global Attention; Interests Lancet: ICMR

Bharat Biotech's Covaxin Gets SEC's Nod

Earlier in the day, in a big milestone for Bharat Biotech, the Special Experts Committee (SEC) deliberating on the Emergency Use Authorization (EUA) applications submitted its recommendations to the Drugs Controller General of India (DCGI). Sources have stated that the expert panel has given its nod for restricted emergency use of Bharat Biotech's vaccine candidate as well.

The Hyderabad-based pharma firm has partnered with the ICMR to develop India's indigenous COVID-19 vaccine - Covaxin. The drugs regulator is likely to give its decision on the applications for the COVID-19 vaccine candidates tomorrow. 

Covaxin, Bharat Biotech’s coronavirus vaccine candidate, has shown antibody and T-cell response in trials among volunteers at three-month follow-ups as well as tolerable safety outcomes, the phase 1 and 2 clinical trial study released recently said. Phase-3 trials are ongoing at 25 centres across India with a total of 26,000 participants.

Meanwhile, India is currently conducting the second 'dry run' of a COVID-19 vaccination drive to test linkages between planning and implementation of the drive and to identify the challenges. The mock drill is being conducted across every state and UT in the country.

Read: SEC To Meet On January 1 To Decide On Serum Institute & Bharat Biotech's COVID Vaccines

 Read: Bharat Biotech's Covaxin Gets SEC's Nod, DCGI Decision On Vaccine Likely Tomorrow: Sources