Biological E Corbevax safe, immunogenic in 5-18 age group

Biological E. Limited 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 a significant Th1 skewed cellular immune response generated from CORBEVAX. There were no severe adverse events (AEs) reported, and the majority of reported adverse events (AEs) were mild in nature.

In February 2022, the Drugs Controller General of India (DCGI) approved CORBEVAX for restricted use in emergency situations for ages 12 to 18. On April 25, 2022, the apex drug regulator also approved the use of the vaccine in children between the ages of 5 and 12. The move came four days after the interim safety and immunogenicity data were presented to the Subject Expert Committee (SEC) on April 21, 2022. It recommended Biological E's CORBEVAX for restricted use in the said age group.

While many countries have vaccinated younger children, India has yet to start the vaccination drive for kids aged between 5 and 12. And CORBEVAX makes for an excellent option in terms of safety and effectiveness against COVID-19. As of now, over 7.36 crore CORBEVAX doses have been administered between the age group of 12-14 pan India during the last seven months of roll-out in one of the largest pediatric vaccination campaigns globally.

Dr. Vikram Paradkar, Executive Vice President-Technical Operations, Biological E. Limited, said, "CORBEVAX getting approved for our pediatric population from 5 to 18 age-group was a major milestone for us and its subsequent Pan-India deployment for kids of 12-14 years was important in our fight against coronavirus. So far, approximately 74 million doses of CORBEVAX has been administered to kids in India, and almost 33 million kids have completed two-dose primary vaccination, which represents one of the largest pediatric campaigns globally. We plan to eventually test the vaccine on infants as young as six months, based on the excellent safety record and consistent immunogenicity observed in pediatric trials and deployment. Publication of our clinical trial results in reputed journals like Lancet eBiomedicine and Elsevier-Vaccine journals represents the validation of CORBEVAX as an excellent choice for the COVID-19 vaccine"

In August, CORBEVAX became the first vaccine in India to get DCGI approval for a COVID-19 heterologous booster shot. It is safer and induces better neutralization antibodies against different variants of coronavirus. It can be administered six months after two doses of COVISHIELD or COVAXIN for all adults.

Reference: SubhashThuluvaa,VikramParadkara, SubbaReddy,Gunneria, VijayYerroju. Safety, tolerability and immunogenicity of Biological E's CORBEVAX™ vaccine in children and adolescents: A prospective, randomised, double-blind, placebo controlled, phase-2/3 study. Vaccine. https://doi.org/10.1016/j.vaccine.2022.10.045