DCGI Approves Phase II/III Trials of Covaxin in 2-18 Age Group

DCGI Approves Phase II/III Trials of Covaxin in 2-18 Age Group

The National Regulator of the country, the Drugs Controller General of India (DCGI), has accepted the recommendation of the 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 after careful examination to its manufacturer Bharat Biotech Ltd on May 12.

Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.

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) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.

Bharat Biotech, which developed Covaxin in association with the Indian Council of Medical Research, submitted the proposal of conducting trials on children early this year. The proposal was deliberated in the meeting of the subject expert committee in February as Bharat Biotech was asked to submit a revised clinical trial protocol.

A few days ago, a wrong claim was doing the rounds that Covaxin has been approved for children above 12 years. The Centre refuted the claim and said no such approval was given.

As India is going through the second wave of the pandemic amid which the ongoing vaccination drive has been opened from people between the age group of 18 and 44 years, the need to extend vaccination to those below 18 years has been felt.Pfizer-BioNTech's Covid-19 vaccine has been given emergency use authorisation for children aged between 12 and 15 in the US. Canada too has approved Pfizer for 12-year-olds.

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