Tuesday, August 9, 2022
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Tuesday, August 9, 2022
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DCGI Gives Nod To Covaxin For Conducting Phase 2,3 Trials On Children

The Drugs Controller General of India (DCGI) on Thursday cleared Covaxin trials on children aged between 2 and 18 years. This is for the first time that the children will go under Covid-19 vaccine trials.

Bharat Biotech, the manufacturer of Covaxin said that it will conduct its phase 2 and 3 trails on “525 healthy volunteers”.

According to the officials, this decision of doing trials over children comes after a recommendation of an expert on the matter.

The various sites where these trials will be conducted include AIIMS Delhi, AIIMS Patna and the Meditrina Institute of Medical Sciences, Nagpur.

The Subject Expert Committee (SEC) on Covid-19 on Tuesday discussed the Bharat Biotech’s request seeking permission for conducting phase 2 and 3 trails “to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years”.

However, the Committee has put up a condition that an interim safety report from phase 2 trails need to be submitted before proceeding to the phase 3 trials.

Covaxin, which is developed by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology is an indigenous vaccine. The other vaccine which is being used in India for vaccination is Covidshiled developed by Oxford-AstraZeneca in collaboration with the Serum Institute of India.

Covaxin was authorised last year for its emergency use while it was still in its trial phase which raised hesitancy among people for the vaccine.

A month ago the Bharat Biotech and ICMR had made it clear that the vaccine is 78% effective against Covid-19 and is 100% effective in preventing from getting serious symptoms ans hospitalisations.

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