NEW DELHI: Days after the government announced that 15 to 17-year-olds in India will be eligible for the Covid vaccine -- only Covaxin for now -- from January 3, its maker Bharat Biotech on Thursday claimed that the vaccine is safe, well-tolerated and immunogenic for the 2-18 age group.
Citing data from the phase 2, 3 clinical trials, the company, in a statement, said that neutralizing antibodies in children, on average, were found to be 1.7 times higher than in adults.
These trials involved 525 participants, categorised into three groups, those aged 12-18 years, kids aged 6-12 years and those aged 2-6 years, comprising 175 subjects each.
“The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity,” said the vaccine maker adding that the data was submitted to the Central Drugs Standard Control Organisation in October based on which it was approved for 12-18 year age group recently.
The statement said that during the study, no serious adverse event was reported and 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within 1 day.
Pain at the injection site, like is the case with most adults receiving the vaccine, was the most commonly reported adverse event.
Seroconversion was documented at 95-98%, in all three groups four weeks after the second dose, indicating superior antibody responses in children when compared to adults, as per the statement.
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 and since Covaxin is an inactivated vaccine corroborative results are expected, said Bharat Biotech.
“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,” said company chairman and managing director Krishna Ella.
“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.”