Biological E yesterday announced the publication of Corbevax COVID-19 vaccine phase-II/III clinical trials conducted in paediatric population (five to <18 age group). The study results have been accepted and published in peer-reviewed international journal Vaccine. Corbevax is India’s first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for COVID-19 that has demonstrated excellent safety profile in children and adolescents, according to a statement from Biological E.
The statement also said that the vaccine also demonstrated excellent immunogenicity as measured by humoral and cellular immune responses. As per observed correlation between neutralising antibody titers against the SARS-COV-2 virus and the vaccine effectiveness, the immune response generated by Corbevax is indicative of high vaccine effectiveness in the five to 18 age-group; similar to what has been observed in the adult population.
Biological E conducted the trial in 624 children with two age cohorts, ≥12 to <18 years (n=312) and ≥5 to <12 years (n=312). Through an intramuscular route, both age groups were administered two doses of 0.5 ml of Corbevax, each separated by 28 days. In both the age groups, Corbevax-vaccinated subjects showed significant immune response against Ancestral-Wuhan and Delta-strains. Cytokine Interferon-gamma expression analysis showed significant Th1 skewed cellular immune response generated from Corbevax. There were no severe Adverse Events (AEs) reported and the majority of reported AEs were mild in nature, as per the statement.
In February 2022, the Drugs Controller General of India (DCGI) had approved Corbevax for restricted use in emergency situations for ages 12 to 18. On 25th April, 2022, the apex drug regulator also approved the use of the vaccine in children between the ages of five and 12 years.