PGI inoculates 33 for Covovax trials
Naina Mishra
Chandigarh, February 13
Post Graduate Institute of Medical Education and Research (PGIMER) here has stopped the further recruitment of vaccine candidates in the age group two to 17 years for the ongoing Covovax vaccine trials at the institute.
No adverse effects till now
We have successfully inoculated 33 candidates for the trials and a majority of them are in the age group of two to six years. We have not encountered any adverse effects till now. These kids will be followed up for six months to determine the immunogenicity of vaccine and antibody response. — Dr Madhu Gupta, Principal Investigator of Covovax trials from PGI
The institute has been able to recruit only 33 candidates due to a lack of will among the parents of children to come forward for the vaccine trials. Initially, the institute was to recruit around 100 candidates for the trials and it had released advertisements for inviting applications twice. The trials began in November last year.
The study objective in this cohort is to evaluate the safety of Covovax in comparison to placebo; and immunogenicity of the vaccine 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.
Dr Madhu Gupta, Principal Investigator of Covovax trials from PGIMER, said, “We have successfully inoculated 33 candidates for the trials and a majority of them are in the age group of two to six years. We have not encountered any adverse events till now. These kids will be followed up for six months to determine the immunogenicity of vaccine and antibody response.” 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.
It is a phase 2/3, observer-blind, randomised and controlled study to determine the safety and immunogenicity of Covovax (SARS-CoV2 recombinant spike protein nanoparticle vaccine).
The vaccine is sponsored by the Serum Institute of India and participation in the trials is purely on a voluntary basis. The multi-centre trials are aimed at checking the safety and immune response of (Covid-19 vaccine) Covovax in children, aged from two to 17 years. Covovax is the 9th vaccine listed by the WHO for emergency use to help vaccination of citizens in low-income countries.
