Home / News / India /  Bharat Biotech seeks DCGI nod for phase 2/3 trial of Covaxin as booster among kids
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Bharat Biotech has sought permission from the Drugs Controller General of India (DCGI) to conduct a phase 2/3 trial of its Covid-19 vaccine Covaxin as a booster shot among those aged between two and 18, reported PTI.

"The Hyderabad-based firm had on April 29 submitted an application to DCGI seeking permission to conduct phase 2/3 trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin as a booster dose in healthy volunteers aged 2 to 18 years," the news agency quoted a person in the know as saying. 

The study is likely to be conducted at six sites, including AIIMS Delhi and Patna.

Covaxin is currently being given to everybody aged 15+ although it has received a nod from DCGI for use in the age group of six to 18 years.

“Earlier approved for children 12-18 years of age, Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study in children 2-18 years of age," Bharat Biotech had earlier said. 

Covid-19 vaccinations for minors in India were started from 3 January onwards for those in the 15-18 age group.

The drive later expanded on 16 March to include children aged above 12.

Booster doses in India

Both Covaxin and Covishield are being administered as booster doses to all adults presently who have completed nine months after the second dose.

India began administering precaution doses of vaccines to the healthcare and frontline workers and those aged 60 and above with comorbidities on 10 January this year. 

The comorbidity clause was removed in March, making all people aged above 60 eligible for the precautionary dose of the Covid vaccine.

The government expanded the ambit of the precaution doses of Covid-19 vaccines and on 10 April began administering the jabs to all aged above 18 years at private vaccination centres. 

The NTAGI is now mulling early administration of the precaution dose to those travelling abroad for education, employment, sporting events and business commitments.

The advisory panel is deliberating on reducing the gap between the second dose of the Covid-19 vaccine and the precaution dose from the current nine months to six months for all.

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