Bharat Biotech International Limited (BBIL) said that its Covid-19 vaccine has demonstrated “robust safety and immunogenicity” in trials for 2-18-year-olds.
The Hyderabad-based vaccine maker said that neutralising antibodies in children were found to be, on an average, 1.7 times higher than in adults.
The vaccine, which is being administered to adults, was approved by the Drugs Controller General of India (DCGI) recently for emergency use in children between 12 and 18 years of age.
Bharat Biotech said that it 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 years age group. BBIL said that Covaxin is the one of the first Covid-19 vaccines in the world for which data is generated for this age group.
The clinical trials were conducted in the pediatric population between June to September 2021 and the data was submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021.
“No serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within one day. Pain at the injection site was the most commonly reported adverse event,” BBIL said.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We have achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children.”
For the trial, 976 children and adolescents were screened for SARS-CoV-2 by RT-PCR and ELISA testing. Of these, 525 eligible participants were enrolled and segregated into three groups - Group I consisted of 12-18-year-olds (n=175), Group II had 6-12-year-olds (n=175), and Group III consisted of 2-6-year-olds (n=175).
Seroconversion was documented at 95-98 per cent in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults. “While in earlier Covaxin studies in adults, cross reactive memory T-cells against all variants of concern was reported, studies are under way to evaluate T-cell responses against the Omicron variant. Since Covaxin is an inactivated vaccine, corroborative results are expected,” researchers said.
Covaxin, jointly developed by ICMR-National Institute of Virology, Pune and BBIL in 2020, is a whole-virion inactivated vaccine, stored at 2-8°C, with 12 months shelf life and multi-dose vial policy.
Covaxin formulation allows the same dosage administration for both adults and children.
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