Krishna Ella-led Bharat Biotech International Ltd. (BBIL) has said its COVID-19 vaccine, COVAXIN, has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects as well as adults (age group 2-18 years) in a phase II-III study. The peer-reviewed data results have been published in Lancet Infectious Diseases, a high-impact factor journal, says Bharat Biotech.

Bharat Biotech says the phase II-III study was conducted to evaluate the safety, reactogenicity, and immunogenicity of COVAXIN among healthy children and adolescents in the 2-18 years age group. "The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity," says the company.

It says the data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021, following which a nod was received for emergency use in children aged 6-18 years. In the study, no serious adverse event was reported, says the company. "A total of 374 adverse events were reported, and the majority of adverse events were mild in nature and resolved within 1 day. Pain at the injection site was the most commonly reported adverse event," says the study.

“Safety of the vaccine is critical for children and we are glad to share COVAXIN has now proven data for safety and immunogenicity in children," says Dr. Krishna Ella, chairman and managing director, Bharat Biotech. He adds the company has achieved the goal of developing a safe and efficacious COVID-19 vaccine for adults and children, for primary immunisation and booster doses, thus making COVAXIN a universal vaccine.

"It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically,” he adds.

What does the study show

A total of 526 children were enrolled on 3 groups for the study. It was found that "vaccination (COVAXIN) was well-tolerated, with no differences in reactogenicity between the three age groups, and no serious adverse events, deaths, or withdrawals due to an adverse event". "Local reactions mainly consisted of mild injection site pain...(and) there were no cases of severe pain and few reports of other local reactions," it finds.

After dose 1, the most frequent solicited systemic adverse event was mild-to-moderate fever, which was reported in eight of 176 participants in group 1; 17 of 175 in group 2; and 22 of 175 in group 3. "No case of severe fever was reported, and rates of all fever were all 4% or less after dose 2," says the study, adding that similar results were obtained using the plaque reduction neutralisation test (PRNT).

COVAXIN is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses, says the company. It is a ready-to-use liquid vaccine and can be stored at 2-8 degrees C, with 12 months shelf life and a multi-dose vial policy. Currently, Bharat Biotech has a stockpile of over 50 million doses of COVAXIN ready to be distributed as required.

phase II-III study

COVAXIN shows safety, immunogenicity in children aged 2-18 years: Lancet