New study published in Lancet Infectious Diseases suggests that Bharat Biotech COVID19 vaccine, COVAXIN induces higher neutralising antibody response in children aged 2-18 years. The company had conducted an age de-escalation study to assess the safety, reactogenicity, and immunogenicity of an inactivated COVID-19 vaccine, COVAXIN.
In this phase 2/3 open-label, non-randomised, multicentre study done in six hospitals in India, healthy children (male or female) aged 2–18 years were eligible for inclusion into the study. Children who had positive SARS-CoV-2 nucleic acid and serology tests at baseline, or any history of previous SARS-CoV-2 infection, or with known immunosuppressive conditions were excluded.
Children were sequentially enrolled into one of three groups and administered with adult formulation of BBV152 as two 0·5 mL intramuscular doses on days 0 and 28. Co-primary endpoints were solicited adverse events for 7 days post-vaccination and neutralising antibody titres on day 56, 28 days after the second dose.
Immunogenicity endpoints were compared with Biodefense and Emerging Infections, Research Resources Repository (BEI) reference serum samples and from adults who received two doses of BBV152 in the same schedule in a previously reported phase 2 study.
Company had enrolled 526 children sequentially into groups 1 (n=176), 2 (n=175), and 3 (n=175). Vaccination 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.
Previously Bharat Biotech demonstrated that two doses of BBV152 are effective in preventing COVID-19 due to SARS-CoV-2 infection in adults, and now show that the vaccine is equally well tolerated and immunogenic in seronegative children aged 2–18 years.
Globally, inactivated vaccines and mRNA vaccines form the majority of COVID-19 vaccines approved for administration to children younger than 18 years. An advantage of this study is the demonstration of acceptable tolerability and significant immunogenicity of BBV152 in children as young as 2 years, supported by a safety profile similar to that in adults. Inactivated COVID-19 vaccines have been shown to be well tolerated and immunogenic in phase 1/2 trials in Chinese children aged 3–17 years.
