DCGI allows Phase II-III clinical trial of Covaxin on 2 to 18-years-old

The Drugs Controller General of India (DCGI) has accorded permission to conduct the Phase II-III clinical trial of Covaxin in the age group of two to 18-years-old to its manufacturer Bharat Biotech Ltd, Union Health Ministry said on Thursday.

“The trial will be conducted in 525 healthy volunteers,” said the Ministry.

In the trial, the Ministry said, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.

After careful examination, the DCGI accepted the recommendation of Subject Expert Committee (SEC). The national drug regulator of the country on Wednesday gave the approval to conduct the clinical trial in the age group of youngest age group till now paving way for them to be saved from the deadly pandemic outbreak.

Hyderabad-based Bharat Biotech International Ltd (BBIL) had proposed to carry out a Phase II-III clinical trial of Covaxin in the age group of two to 18 years.

As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) on May 11 this year.

The committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II-III clinical trial to certain conditions.