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Covaxin trials on children begin at AIIMS Patna: All you need to know

The Drugs Controller General of India (DCGI) gave clearance for clinical trials of Covaxin on children on May 11.
Written by Prashasti Singh | Edited by Avik Roy, Hindustan Times, New Delhi
PUBLISHED ON JUN 03, 2021 07:04 AM IST
Physical examination and real-time polymerase chain reaction (RT-PCR) were conducted on children before administering the vaccine to check for Covid-19 antibodies or any other pre-existing diseases.(PTI)

Trials of the coronavirus disease (Covid-19) vaccines manufactured by Bharat Biotech, Covaxin, began on children between the age of two and 18 at Patna's All India Institute of Medical Sciences (AIIMS) after the Drugs Controller General of India (DCGI) gave clearance for the same on May 11.

“We began the children’s trials by administering the vaccine on three volunteers in the 12-18 years age group,” said Dr Lokesh Tiwari, the additional professor and head at the department of paediatrics and one of the investigators in the trials at AIIMS-Patna.

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"Children in the 12 to 18 years age group will be given the shots first. We will then proceed with the 6-12 years category before inoculating children in the two-to-six-years age bracket,” said Dr CM Singh, professor of community and family medicine and the principal investigator of the trial.

As many as 54 children had registered at the institute for the trials of which 16 were in the 12-18 years age group.

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Here is all you need to know about Covaxin trials on children:

- The DCGI's nod to conduct clinical trials in children came on May 11. "Covaxin has been approved by the DCGI, for Phase II/III clinical trials in the age group of 2 to 18 years." Niti Aayog member VK Paul had announced.

- Physical examination and real-time polymerase chain reaction (RT-PCR) were conducted on children before administering the vaccine to check for Covid-19 antibodies or any other pre-existing diseases.

- Both doses of the vaccine will be administered to 525 healthy volunteers at an interval of 28 days. “There is no specific target on the number of volunteers given to any centre participating in the research. We hope to enrol 100 child volunteers for the trial,” Dr Singh said.

- All volunteers will be given a conveyance reimbursement of Rs1,000 per visit to the hospital, the doctor added.

- India started the world's largest vaccination drive on January 16 this year in a phased manner. Healthcare workers were given vaccines first, vaccination of the frontline workers started next on February 2, and the next phase of the drive began on March 1 for those above the age of 60 and for people aged 45 and above with specific comorbidities. India launched vaccination for all those above 45 from April 1 and the third phase of the vaccination started on May 1 for the beneficiary in the 18-44 age group.

- Bharat Biotech's Covaxin, Serum Institute's Covishield and Russia's Sputnik V are being used to inoculate Indians. Covaxin and Covishield are being manufactured in India.

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