The Phase II/III clinical trials of Corbevax, the Covid vaccine of Biological E, conducted in paediatric population of 5 to 18 age group, have been published in Vaccine, a peer-reviewed international journal.
Corbevax is India’s first indigenously developed Receptor Binding Domain (RBD) protein sub-unit vaccine for Covid.
“Publication of our clinical trial results in reputed journals like Lancet eBiomedicine and Elsevier-Vaccine journals represents the validation of Corvevax as an excellent choice for Covid vaccine,’‘ said Vikram Paradkar, Executive Vice-President, Technical Operations, Biological E. .
“Corbevax getting approved for our pediatric population, from 5 to 18 age group, was a major milestone for us. So far, approximately 74 million doses of Corbevax have 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,’‘ he added.
The company is planning to eventually test the vaccine on infants as young as six months.
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 “very high vaccine effectiveness’‘ in the 5 to 18 age-group, similar to what has been observed in the adult population, said the release.
Biological E conducted the trials of the vaccine in 624 children with two age cohorts. 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.
In February 2022, the Drugs Controller General of India (DCGI) approved Corbevax for restricted use in emergency situations for ages 12 to 18. In April the apex drug regulator also approved the use of the vaccine in children between the ages of 5 and 12.
In August, Corbevax became the first vaccine in India to get DCGI approval for a Covid 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.
While many countries have vaccinated younger children, India has yet to start the vaccination drive for kids aged between 5 and 12.