PGIMER yet to get ethical clearance for Covovax trial on kids

As PGIMER is already in the process to hire staff for the research trial of Covovax, a Covid Vaccine of Pediatric Populace; the ethical clearance is yet awaited. Though there is no hindrance in getting the clearance faced by PGIMER as it is taking its due course time. The ethical clearance is soon to be with PGIMER in the coming week. 

Meanwhile, the Drug General Controller of India got the preliminary data for Covovax and it is expecting an approval soon for further requisite actions. A total of 920 eligible children will be enrolled in this study across 24 centres in the country. Of these, 460 participants will be in the age group of 12 to 17 years and another 460 in the 2 to 11 years age group. 

As per the Principal Investigator of the trial, Prof Dr Madhu Gupta, “The study is aimed at checking the safety and immune response of Covovax in children, aged 2 to 17. The objective of the study is to evaluate the safety of Covovax about placebo, and its immunogenicity in children in the age groups of 12-17 years and 2-11 years in comparison to adult participants checking reactions and immunity (Antibody level) both in separate groups. 

Dr Jagat Ram, Director, PGI, said, “The trial will begin soon after ethical clearance in the coming week. These will be performed on children aged 2 to 17. The efficacy of the vaccine was more than 90% as per the trials.”

Dr Gupta, said, “We will recruit 100 candidates for the vaccine trial. The trial is expected to start by mid or end of September.” All eligible participants (920) will be randomized in a 3:1 ratio to receive two doses (0.5 ml each) of either Covovax or Placebo, respectively, on Day 1 and Day 22.

The Drug General Controller of India got the preliminary data for Covovax and it is expecting an approval soon for further requisite actions. A total of 920 eligible children will be enrolled in this study across 24 centres in the country.