One among 10 Hospitals selected for trials in India; Dedicated team formed

Mysore/Mysuru: Amid a debate around inoculating children for the deadly COVID infection and the threat of the third wave where teens and children are predicted to be the worst affected, Cheluvamba Hospital in Mysuru has been selected by Institutional Ethics Committee for Covaxin’s clinical trials in children aged two to 18 years. 

According to Clinical Trial Registry of India, Cheluvamba Hospital, a reputed State-run hospital for woman and children under the Mysore Medical College and Research Institute (MMC&RI), is the only hospital in Karnataka and one among the 10 hospitals in India that have been selected for clinical trials.

It may be recalled here that the Phase-2 human trials of Oxford University’s ‘Covishield’ was conducted at Mysuru’s JSS Hospital and Medical College in August-September last year.  

The Drug Controller General of India gave Hyderabad-based pharma company Bharat Biotech Ltd. the green signal to conduct the trials in the 2-18 age groups on May 13. In the trial, the vaccine will be given by intramuscular route in two doses, on day 0 and day 28.

The Ethics Committee has stated that a total of 525 children will be part of the trial in three age groups — 2 to 6, 6 to 12 and 12 to 18 — where safety, reactogenicity and immunogenicity of the vaccine in children will be assessed. Over 175 children will be inoculated in each age group. 

Confirming this to SOM this morning, MMC&RI Dean and Director Dr. C.P. Nanjaraj said that initially, the Ethics Committee for Covaxin’s clinical trials in children had identified five institutions including Cheluvamba Hospital and now 10 institutions have been selected. 

Trials at paediatric ward 

The trials will be conducted at the paediatric ward of the Cheluvamba Hospital. “We may conduct trials on 40 children — depending on the approval by the Centre — first in the age group of 12 to 18 and the dosage has to be decided by the Centre. We are awaiting guidelines,” he said. Both Dr. Nanjaraj and MMC&RI Principal Dr. K.R. Dakshayani are in the Ethics Committee. 

“As of now, trials will be conducted in the paediatric ward and we will inspect the facilities there in a day or two. We are awaiting SOPs for the identification and mobilisation of children,” he said and added that MMC&RI has done a number of clinical trials before, including for BCG on senior citizens.

Dedicated team

The MMC&RI has formed a dedicated team to conduct the trials on children comprising Head of Pathology Department Dr. Bharathi and Associate Professors Dr. Prashanth and Dr. Pradeep. This apart, one scientist each from CFTRI and University of Mysore will be chosen.

Meanwhile, some Western nations including the US have started vaccinating children above the age of 12. Pharma giants Pfizer and Moderna are already conducting trials of their COVID vaccines on children over six months old. Different dosages of the vaccine — 10 micrograms, 20 micrograms and 30 micrograms — are being tested in three age groups under the Pfizer trial, in accordance with the tolerance levels. 

Centre’s stand

Member (Health) in NITI Aayog and the Chair of NEGVAC, Dr. Vinod K. Paul announced that vaccine trials on children in India would begin soon. “Trials in children in India are also going to begin soon. However, vaccinating children should not be decided on the basis of panic in WhatsApp groups and because some politicians want to play politics,” Paul said.