Hyderabad-based vaccine manufacturer Bharat Biotech stated on Thursday that its Covaxin COVID-19 vaccine has proven to be safe, well-tolerated, and immunogenic in 2-18 years of age volunteers who participated in Phase 2 and 3 study of the jab.
Bharat Biotech had conducted Phase 2 and 3, 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 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity," noted the pharma major in an official statement. Neutralizing antibodies in children on an average 1.7 times higher than in adults. No cases of myocarditis or blood clots were reported, as expected with inactivated vaccines.
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 on December 25.
In the study, no serious adverse event was reported. Bharat Biotech explained that 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within 1 day. Pain at the injection site was the most commonly reported adverse event, according to the firm.
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," she added.
The firm explained that in earlier Covaxin 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 Covaxin, is an inactivated vaccine corroborative results are expected, noted the firm.
Also Read: What happens when Covaxin vial is open and no patient is there? Bharat Biotech explains
Also Read: DGCI gives emergency use approval to Bharat Biotech's Covaxin for 12-18 years age group