National
Bharat Biotech says Covaxin found to be safe for children in phase 2 and 3 trials
Bharat Biotech has said that its Covid-19 vaccine Covaxin has proven to be safe, for children between 2 to 18 years of age. The government has already given approval to use Covaxin for vaccinating children in the 15-18 age group from January 3.
This comes after the Drugs Controller General of India (DCGI) approved the use of Covaxin for children aged 12 years and above. The subject expert committee advising the regulator had cleared the vaccine for use in two-year-old children and above.
Bharat Biotech has conducted phase 2 and 3, open-label, multi-center studies to evaluate the safety, reactogenicity, and immunogenicity of Covaxin in healthy children and adolescents in the age group of 2 to 18.