Covaxin filed with FDA for Emergency Use Authorization in COVID-19.- Ocugen

The submission is based on results of a Phase II/III pediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase III safety and efficacy clinical trial in nearly 25,800 adults in India. The neutralizing antibody responses against wild-type strain in the pediatric age group of 2-18 years were equivalent to those seen in adults, ages 18+ years, in Bharat Biotech’s large Phase III efficacy and safety trial. More than 90 percent of the seroconversion rates were observed for antibody titers against S1, RBD, N proteins and wild-type neutralizing antibodies. These results suggest similar protection in children, ages 2-18, to that demonstrated in adults older than 18 years.

Among the 526 study subjects in the pediatric clinical trial, no serious adverse effects, such as deaths, hospitalizations, myocarditis, pericarditis, Guillain-Barre syndrome, vaccine-induced thrombotic thrombocytopenia or anaphylactic reactions were reported in the study. These were also not observed in the surveillance data collected in India following the administration of over 59 million doses of Covaxin (BBV152) in adults. All other adverse events were mild or moderate in nature and were generally resolved within 24 hours.