Covaxin for kids: 'Robust safety' in age group of 2-18 years, study finds

Hyderabad-based pharma giant Bharat Biotech on Thursday announced that its COVID-19 vaccine Covaxin (BBV152) for kids has proven to be safe, well-tolerated, and immunogenic in pediatric subjects in Phase 2-3 study. The trials found out that the vaccine successfully neutralized antibodies in children on an average of 1.7 times higher than in adults. Moreover, no serious adverse event was reported apart from 'pain at the injection site' which was the most commonly reported adverse event. There were also no cases of myocarditis or blood clots reported, as expected with inactivated vaccines, Bharat Biotech stated. 

"Bharat Biotech 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 pediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity," Bharat Biotech said in a statement.

The Drugs Controller General of India (DCGI) had given nod to Bharat Biotech's COVID-19 vaccine Covaxin (BBV152) for kids between 12 -18 years of age for emergency use on December 25. Like most vaccines for adults, children between 12 to 18 years of age will be administered Covaxin in two doses. The interval and dosage are likely to be the same as adults. The vaccination for them will begin on January 3, 2022.

Results of Covaxin trials for kids 

In the study, 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within one day. Pain at the injection site was the most commonly reported adverse event. 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, the pharma giant detailed.

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.

Issuing a statement, 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.”
 

In earlier COVAXINÒ studies in adults, cross-reactive memory T cells against all variants of concern were reported. Studies are now underway to evaluate T cell responses against the Omicron variant. Since COVAXINÒ, is an inactivated vaccine corroborative results are expected.