HYDERABAD: The phase II and III clinical trials of Corbevax for children between five and 18 years have shown the vaccine is safe and fights the Covid-19 infection. The vaccine successfully nullified the effect of both the ancestral strain of Covid-19 from Wuhan and its progeny Delta strain.
The study based on clinical results was published in the latest issue of the scientific journal, Vaccine. Corbevax is India's first indigenously developed receptor binding domain (RBD) protein sub-unit vaccine for the pandemic virus. It also demonstrated excellent immunogenicity as measured by humoral and cellular immune responses, the study said.
The vaccine was developed by city-based Biological E Limited. The vaccine's effectiveness on children was similar to what has been observed in adult population, the study said. The trial was conducted on 624 children with two age cohorts, between 12 and 18 years and five and 12 years. Through an intramuscular route, both age groups were given two doses of 0.5ml of Corbevax, each separated by 28 days. In both age groups, vaccinated subjects showed significant immune response against ancestral-Wuhan and Delta-strains.
"Cytokine Interferon-gamma expression analysis showed significant T helper type 1 or Th1 skewed cellular immune response generated from Corbevax. There were no severe adverse events reported and the majority of reported adverse events were mild in nature," the study revealed.
Drugs Controller-General of India approved Corbevax in February this year for restricted use in emergency situations for ages 12 to 18. On April 25, it approved its use in kids between ages of five and 12. The move came four days after interim safety and immunogenicity data were presented to subject expert committee on April 21. It recommended the vaccine for restricted use in said age group.