Bharat Biotech's Covaxin approved for phase 2/3 trials on children


 

India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.

The trial will be conducted on 525 healthy volunteers.

"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," the ministry said.

Hyderabad based Bharat Biotech had proposed to carry out the clinical trial in the age group of 2 to 18 years.

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

As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) on COVID-19 meeting held on May 11. Read More

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