Covaxin trials on children begin at AIIMS-Patna
Patna’s All India Institute of Medical Sciences (AIIMS) on Tuesday began the phase II/III clinical trials of the indigenous Covaxin (Covid vaccine), developed by the Bharat Biotech International Limited, Hyderabad, on children in the age group of 2 to 18 years.
“We began the children’s trials by administering the vaccine on three volunteers in the 12-18 years age group,” said Dr Lokesh Tiwari, additional professor and head, department of paediatrics, also one of the investigators in the trials at AIIMS-Patna.
As many as 54 children had registered at the institute for the trials of which 16 were in the 12-18 years age group.
“We are commencing the trials today in the reverse order of age from today. Children in the 12 to 18 years age group will be given the shots first. We will then proceed with the 6 to 12 years age category before inoculating children in the 2 to 6 years age bracket,” said Dr CM Singh, professor of community and family medicine, also the principal investigator of the trial at AIIMS-Patna and medical superintendent.
“Besides physical examination of the child, we will conduct real-time polymerase chain reaction (RT PCR) to check them for Covid antibody and test them for any pre-existing diseases before administering the vaccine,” he said.
The two doses of the whole virion, inactivated SARS-CoV-2 vaccine, will be administered at an interval of 28 days through intramuscular shots.
The trials will be carried out on 525 healthy volunteers. “There is no specific target on number of volunteers given to any centre participating in the research. We hope to enrol 100 child volunteers for the trial,” said Dr Singh.
Those participating in the trials would be given a flat conveyance reimbursement of ₹1,000 per visit to the institute, he added.
The AIIMS-Patna had undertaken Covaxin trial on 1,306 adults last year before the national regulator, the Drugs Controller General of India, approved the vaccine for emergency use. The first phase trial, which was of 194 days duration, on 46 volunteers was completed on February 3 and the second phase on 44 volunteers got over on April 7. The 208-day third phase trial, initiated in December 2020 on 1,216 volunteers, would end in September this year.
AIIMS-Patna is one of the research sites for the Covaxin’s clinical trials in children. The others are AIIMS-Delhi; ESI Hospital, Basaidarapur (Delhi); Prakhar Hospital, Kanpur; Mysore Medical College and Research Institute, Mysuru, Pranaam Hospital, Hyderabad; and Meditrinia Institute of Medical Sciences, Nagpur.