Bharat Biotech submits Covaxin’s phase 3 trial data to DCGI

A Subject Expert Committee (SEC) under the drugs regulator is likely to meet today to evaluate and discuss the results obtained.

Vaccine maker Bharat Biotech has submitted the results of the phase 3 trials conducted on its indigenously developed COVID-19 vaccine called Covaxin to the Drug Controller General of India (DCGI). A Subject Expert Committee (SEC) under the drugs regulator is likely to meet today to evaluate and discuss the results obtained.

The Hyderabad based Bharat Biotech had been facing extensive criticism for the delay in publishing phase 3 results for Covaxin. Talking to news agency ANI, the company said that it would first submit its trial data to the CDSCO and afterwards to peer-reviewed journals. Earlier in March this year, it had announced an interim efficacy of 81% in preventing Coronavirus. However, the final results, which are crucial to proving the vaccine’s efficacy have not been published as yet.

On Wednesday, the company is expected to meet officials from WHO in a pre-submission meeting as a part of its application for emergency use listing (EUL) of Covaxin. Getting WHO’s approval is crucial for Bharat Biotech as it would allow it to easily export its vaccine and ensure that Covaxin is recognised as a valid COVID-19 vaccine by countries around the world.

Covaxin is currently one of the three COVID-19 vaccines available in India apart from Serum Institute’s Covishield and the Russian Sputnik vaccine.

Bharat Biotech has also announced a phase 4 trial for Covaxin to test its ‘real-world effectiveness’ and ensure that it follows ‘rigorous scientific standard’. The indigenously developed vaccine is already being tested on children in the age group of 2-18 years amid fears of children being badly affected in the third wave of coronavirus.

 

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