Bharat Biotech International Limited (BBIL) has said Covaxin, its whole-virion inactivated Covid-19 vaccine candidate, has proven to be “safe, well-tolerated, and immunogenic” in paediatric subjects in phase II/III study.
The Hyderabad-based company had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the 2-18 age group.
The clinical trials conducted in the paediatric population between June and September 2021 have shown “robust safety, reactogenicity, and immunogenicity,” the company said in a release on Thursday.
‘Encouraging data’
The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October, and received nod for emergency use in children aged between 12 and 18, from the DCGI recently.
In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within a day. Pain at the injection site was the most commonly reported adverse event.
“The 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,” Krishna Ella, Chairman and Managing Director, Bharat Biotech, said.
“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,” he added.
For the purpose of Phase II/III study for paediatric use, 976 subjects were screened in trials for SARS-CoV-2 by RT-PCR and ELISA testing. 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, group II consisted of children of age 6-12 years, and group III consisted of children of age 2-6 years.
Seroconversion was documented at 95-98 per cent four weeks after the second dose, indicating superior antibody responses compared to adults.