New Delhi: Bharat Biotech announced on Friday that the use of its anti-Covid vaccine BBV152 or Covaxin on children aged 2-18 has been peer-reviewed and the study published in a leading medical journal, concluding that it is safe and carries minimal side-effects.
Trials for these 526 children were conducted at six hospitals in India last year to collect data, according to the publication shared by the company. It was published online in The Lancet Infectious Diseases journal on June 16.
A total of 374 "adverse events" or side-effects were reported; majority of these were mild and resolved within a day, the company said. Pain at the injection spot was the most common adverse event.
As for how effective it is, the conclusion of the study published in the Lancet journal says only the immune response has been studied, not clinical efficacy, in children. It also says, "The small size of the study means that we cannot draw firm conclusions about vaccine safety in children as rare events will only be detected in larger surveillance studies, which are ongoing." The vaccine does induce an immune response, the published data says.
The vaccine has so far received permissions for emergency use in children aged 6-18 years in India - for the 12-18 in December 2021, and then for 6-12 in April this year. Trial data had been submitted to the Central Drugs Standard Control Organisation (CDSCO) in October 2021.
Dr Krishna Ella, chairman and managing director of Bharat Biotech, said, "Safety of the vaccine is critical for children. Covaxin has proven to be a highly safe, based on data from more than 50 million (5 crore) doses administered to children in India."
The company claimed it has "a stockpile of more than 50 million doses of Covaxin ready to be distributed as required". "Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses, making it truly a universal vaccine," it added.