Bharat Biotech's Covaxin Recommended By DCGI's Expert Panel For Phase 2 And 3 Trial On 2 To 18 Years Old: Report

The subject expert panel (SEC) of India's drug regulator has reportedly recommended for grant of permission to Bharat Biotech to conduct phase 1 and 2 trials of is Covid-19 vaccine Covaxin on non-adults between 2-18 years of age.

Bharat Biotech has developed the Covaxin, which is India's first indigenous Covid-19 vaccine, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The Covaxin had been approved for emergency use in those aged above 18 years in January and is currently being used in Covid-19 vaccination drive across India.

"Bharat Biotech's Covid-19 vaccine Covaxin recommended by expert panel for phase 2 and 3 clinical trials on 2 to 18 year-olds" sources were quoted by PTI as saying.

It should be noted that Bharat Biotech had earlier last month announced that the Covaxin has demonstrated overall Interim clinical efficacy of 78 per cent and 100 per cent efficacy against severe COVID-19 disease as per the interim results of the Phase 3 clinical trials of the vaccine.

The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60, with analysis conducted 14 days post second dose, the company said.

So far, three Covid-19 vaccines - Serum Institute of India's Covishield, Bharat Biotech's Covaxin and Russian Sputnik V - have been approved in India for emergency use.