COVAXIN has proven safe in paediatric use: Bharat Biotech

at 9:11 pm

Hyderabad: Bharat Biotech today said its BBV152 (COVAXINÒ) has proven to be safe, well-tolerated and immunogenic in paediatric subjects in phase II/III study.

Bharat Biotech conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity COVAXIN® in healthy children and adolescents in the 2-18 age group, it said in a release.

“The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity,” the release said.

“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,” it added.

“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. Pain at the injection site was the most commonly reported adverse event,” the company said.

The statement came against the backdrop of the government announcing a few days back that children in the age group of 15-18 years can be vaccinated with COVAXIN.

The announcement came amidst the steady rise in the cases of Omicron variant of Covid in the country.

Bharat Biotech said 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 COVAXINÒ 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 COVAXINÒ, is an inactivated vaccine corroborative results are expected.

Bharat Biotech Chairman and Managing Director Dr Krishna Ella said, “COVAXIN®’s clinical trial data from the pediatric 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.”