The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received emergency use nod for children aged 12-18 from DCGI, recently. In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within 1 day.
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "COVAXIN's clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children and we are glad to share that COVAXIN has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically."
About COVAXIN Phase II/III study analysis for paediatric use
For the trial, 976 subjects were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Out of these, 525 eligible participants were enrolled. Based on the age, participants were distinguished into three groups in an age de-escalatory manner. Group I consisted of children of age 12-18 years (n=175), group II consisted of children of age 6-12 years (n=175), and group III consisted of children of age 2-6 years (n=175).
Seroconversion was documented at 95-98%, in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults and also displayed Th1 bias. In earlier COVAXIN studies in adults, cross reactive memory T cells against all variants of concern was reported. Studies are underway to evaluate T cell responses against the Omicron variant. Since COVAXIN, is an inactivated vaccine corroborative results are expected.
COVAXIN, is formulated uniquely such that the same dosage can be administered to adults and children alike. COVAXIN is a ready to use liquid vaccine, stored at 2-8ºC, with 12 months shelf life and multi dose vial policy.
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