Covid-19 vaccination: 30 kids aged 12-18 years get Covaxin trial jabs in Mysuru

MMCRI is the only site selected in Karnataka for Bharat Biotech's paediatric trials

As many as 30 children aged between 12-18 years were administered Covaxin on June 6 at Mysuru Medical College and Research Institute (MMCRI) as part of Hyderabad-based pharmaceutical major Bharat Biotech's clinical trials.

MMCRI is the only site selected in Karnataka for the company's paediatric trials, currently being conducted pan-India across multiple locations.

On a positive note, when the vaccinated kids were followed up telephonically, mild pain at the injection site was observed in 10 subjects. No other complications were reported.

In all, MMCRI had screened 53 subjects, of which 23 had to be rejected as they were ineligible for the trial, on account of either having antibodies or active infection.

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The kids hail from all kinds of socio-economic backgrounds: middle class, upper-middle class as well as those from lower-income groups. Their parents have academic, agricultural, scientific and business backgrounds.

However, it may be early next year before the observation period for these children is complete as the kids will be monitored for 208 days, that is, till December this year or early January next year.

During this period, they will pay five visits to the investigators of the clinical trial in the medical college. The levels of Covid IgG antibodies will be checked in their blood samples every visit.

Dr C P Nanjaraj, dean, MMCRI, told DH, "We shall be screening 50 subjects in each group: 12 to 18 years, 6 to 12 years, and 2 to 6 years. During screening, we shall draw blood samples for Covid IgG antibodies and nasopharyngeal swabs for RT-PCR test."

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"If IgG antibodies and RT-PCR are negative, they (children) will be eligible to get into the study. The study subjects (children) will be given two doses of vaccine 28 days apart, and will be followed up for six months for safety analysis."

The dean explained that the college did not have to mobilise children for the trial because, as soon as the news of the paediatric clinical trials was out, eager parents started calling up the college to enrol their children in the trial voluntarily.

"Blood sampling will be done on each visit. During visit one, the first dose will be administered, visit two (second dose), visit three (28 days after second dose), visit four (117 days), and visit five (208 days). Screening for subjects in other age groups will start only after completion of recruitment of 175 subjects in all trial centres across India for the 12-18 age group," he said.