NEW DELHI: Bharat Biotech’s Covaxin has proven to be ‘safe, well-tolerated, and highly immunogenic’ in children in Phase II/III studies, the results of which are published in the prestigious Lancet journal.
The study said that the data from over 50 million doses given to children in India reveals that side effects are minimal.
The trials were conducted on 526 children at six hospitals in India for data collecting. A total of 374 adverse events were reported. The majority of adverse events were mild in nature and resolved within a day. Pain due to injection happened to be the most common adverse effect.
Importantly the study reveals that “data on pharmacovigilance and AEFI (Adverse event following immunization) after introduction in several countries are very positive”. The data also showed that vaccine-related cases of AEFI such as myocarditis, blood clots and pericarditis were not reported.
Its effect on neutralizing antibodies in children on an average is 1.7 times higher than in adults, however the same dosage of Covaxin can be administered to adults and children, for primary immunization and booster doses making it a universal vaccine, the study claims.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “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.”
“It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool. The power of vaccines can only be harnessed if used prophylactically,” Dr Ella added.
Bharat Biotech has a stockpile of more than 50 million doses of Covaxin ready to be distributed as required.