In all 30 children, aged 12-18, were administered Covaxin 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, according to sources.
In all, MMCRI had screened 53 children, of which 23 had to be rejected as they were ineligible for the trial, on account of either having antibodies or active infection.
Earlier, AIIMS Patna has started the Paediatric clinical trial of the Covaxin after Bharat Biotech received the Drugs Controller General of India (DCGI) nod to conduct clinical trials on children. Right now, AIIMS Patna has started trials on the age group of 12-18 years. Children’s safety is the need of the hour as several experts have warned that the third wave is likely to affect children more…
So, wide spread vaccination is a critical tool to help stop the pandemic. Getting a COVID-19 vaccination can help protect children from getting COVID-19. That is why these trials are very important. The Central Govt is making all the necessary preparations to deal with any such situation because Children are the nation’s future. If the clinical trials are successful, India will join the list of countries like the US, China, Germany, and others that have approved vaccination for children. Covaxin is currently only being administered to adults above the age of 18 as part of India’s inoculation drive.
Dr. VK Paul, Member, Niti Aayog had earlier said that Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. The DCGI’s approval follows the recommendation of a Subject Expert Committee on May 12 to grant such permission. The trial of Bharat Biotech’s Covid vaccine Covaxin will be conducted on various healthy volunteers at different sites across the country. The trial will study different aspects like the safety of the vaccine in this age group, and the types of adverse reactions and their causes. The trial will also examine the vaccine’s ability to prompt an immune response. There is no doubt that Vaccines are only given to children after careful review by scientists, doctors, and healthcare professionals.
According to Dr. C P Nanjaraj, Dean, MMCRI, screening 50 children in each age 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 tests.
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.”
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