Tribune News Service
Chandigarh, November 22
The PGI has successfully administered Covovax (Covid-19 vaccine for paediatric population) to eight children, aged between two and 11.
‘No side effects’
We have administered the vaccine to eight children in the age group of 2 to 11 and so far, there have been no side effects. We will be recruiting 100 candidates in the same age group. — Dr Madhu Gupta, Principal Investigator, Covovax trial, PGI
The multi-centre trial is aimed at checking the safety and immune response of (Covid-19 vaccine) Covovax in children, aged two to 17 years.
Dr Madhu Gupta, principal investigator of the Covovax trial at the PGI, said, “We have administered the vaccine to eight children in the age group of 2 to 11 and so far, there have been no side effects.”
Initially, the PGI was to recruit candidates from two to 17 years for the study, but the trial was started late and the target for enrolling participants was achieved in other centres of the country.
All eligible participants will be randomised in a 3:1 ratio to receive two doses of 0.5 ml each of either Covovax or Placebo, respectively, on Day 1 and Day 22.
The study vaccine is injected intramuscularly (into a muscle) in the deltoid or the anterolateral aspect of the thigh as two doses of 0.5 ml each on Day 1 and Day 22. The participants are observed closely for 30 minutes post-vaccination. The study objective in this cohort is to evaluate the safety of Covovax in comparison to Placebo; and immunogenicity of Covovax in children from two to 11 years of age in comparison to adult participants (adult participants in the reactogenicity and immunogenicity cohort from the Covovax group), separately. Reactogenicity refers to a subset of reactions that occur soon after the vaccination and the immunogenicity of the vaccine is the antibody response provoked in the human body after administering the vaccine.
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