Accepting the recommendation of an expert committee on vaccines, the Drugs Controller General of India (DGCI) has given the go ahead to Bharat Biotech for Phase 2 and 3 clinical trials of it’s coronavirus vaccine Covaxin for the 2-18 years age group. This is the first time that a COVID-19 vaccine will be tested on children.
The government statement said DGCI accepted the recommendation of the expert committee on vaccines after careful thought. Hyderabad-based Bharat Biotech said its phase 2 and 3 trials would be carried out on “525 healthy volunteers”.
The trial involves two vaccine doses injected at day 0 and day 28.
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“The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on May 12, 2021,” the ministry said.
As a rapid regulatory response, the proposal was deliberated in the Subject Expert Committee (SEC) (COVID-19) on May 11, 2021.
The Committee after detailed deliberation recommended for grant of permission to conduct the proposed Phase 2 and 3 clinical trials to certain conditions.
Covaxin is one of the two vaccines being manufactured in India at present and has been developed by Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology.
The firm on Tuesday informed that it has been supplying its COVID-19 vaccine directly to 18 states since May 1. (With ANI inputs)