Bharat Biotech's Covaxin safe for children aged 2-18, suggests Lancet Journal
Trials for 526 youngsters were undertaken at six hospitals in India last year to collect data, as per the company's release.
Bharat Biotech, on Friday, stated that its anti-Covid vaccine BBV152 or Covaxin has been peer-reviewed and published in a renowned medical journal, indicating that it is safe and has few negative effects in children aged 2 to 18.
According to the company's release, trials for these 526 youngsters were undertaken at six hospitals in India last year to collect data. On June 16, it was published in The Lancet Infectious Diseases journal online.
According to the manufacturer, 374 "adverse occurrences" or side effects were reported, most of which were minor and resolved within a day. The most prevalent side effect was pain at the injection spot.
In terms of efficacy, the conclusion of the study published in the Lancet journal states that only the immune response has been evaluated in children, not clinical efficacy. "Because uncommon cases will only be detected in larger monitoring studies, which are ongoing," it says, "we cannot reach clear conclusions about vaccine safety in children due to the restricted trial size." The immunisation does, according to the research, elicit an immune reaction.
In India, the vaccine has been approved for emergency use in children aged 6 to 18, first for the 12-18 age group in December 2021 and then for the 6-12 age group in April this year. In October 2021, trial data was submitted to the Central Drugs Standard Control Organization (CDSCO).
Bharat Biotech's chairman and managing director, Krishna Ella, stated, "The vaccine's safety is crucial for children. Based on data from more than 50 million (5 crores) doses delivered to children in India, Covaxin has proven extremely safe."
"We have a stockpile of more than 50 million doses of Covaxin ready to be given as needed," the company asserted. The statement stated, "Covaxin is made so that the same dose can be given to adults and children for both primary and booster doses, making it a universal vaccine."