Covaxin clinical trials on children begin at MMC&RI
Coronavirus Update, News

Covaxin clinical trials on children begin at MMC&RI

June 11, 2021

30 kids get trial jabs at Cheluvamba; No vaccine adverse effects observed

Mysore/Mysuru: Hyderabad-based pharmaceutical major Bharat Biotech has begun the clinical trials of its COVID-19 vaccine, Covaxin, on children aged 12-18 years in several parts of the country including Mysuru where children volunteers have started receiving their shots. In Mysuru, the trials are being conducted at Child Rehabilitation Centre of the State-run Cheluvamba Hospital, managed by the Mysore Medical College and Research Institute (MMC&RI). 

The first trials were conducted last Saturday and Sunday where 53 child volunteers between the age group of 12 and 18 were selected. Of them, 30 were vaccinated and among them, 25 children were from Mysuru and five were from Bengaluru. MMC&RI is the only site selected in Karnataka for the company’s paediatric trials, currently being conducted pan-India across multiple locations. 

Speaking to Star of Mysore this morning, MMC&RI Dean and Director Dr. C.P. Nanjaraj said that the Ethics Committee for Covaxin’s clinical trials in children selected the Hospital. “Based on the Standard Operating Procedures (SOPs), the Child Rehabilitation Centre has been converted into a vaccination trial centre,” he said. 

“During screening, we 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 will be given two doses of vaccine 28 days apart and will be followed up for six months for safety analysis,” he added.

Some children had to be rejected as they were ineligible for the trial on account of either having antibodies or active infection. Before the shots are administered, the children are taken for audio-visual counselling and their consent is obtained. 

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After vaccination, they are kept here for two hours and then sent home. They will be continuously monitored for seven days for any signs of fever, fatigue and exhaustion. “All the parameters in the SOP are followed stringently and the monitoring will continue for six months,” he added. 

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. “No serious effects were observed and we are happy that volunteers are coming on their own for trials. There is a demand from parents and youngsters too,” Dr. Nanjaraj added. 

They will receive the second dose after 28 days, following which their blood samples will be checked to see if antibodies have developed against COVID-19. The next phase of trials will begin for children between the age group of 6 and 12 and then for children between 2 and 6 years. 

The trials are being done under the supervision of Paediatricians. Dr. Pradeep and Dr. Prashanth are the Principal Investigators and are assisted by V. Sakamma, Nursing Superintendent of Cheluvamba Hospital and Pooja and Reena, both Clinical Researchers. 

The Child Rehabilitation Centre has been set up at Cheluvamba as per the directions from the Medical Council of India. It is a separate building in the Cheluvamba campus and earlier, the building served as a kitchen for the Hospital patients. Now the food is being supplied from the K.R. Hospital in a centralised system. 

Across the nation, a total of 525 healthy children have been roped in for the trials and they have been divided into three age groups. 175 volunteers each in 12-18, 6-12 and 2-6 age groups will be inoculated with doses.

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