Covaxin is safe for 2-18 age group in phase 2, 3 trials: Bharat Biotech

A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6% getting resolved within a day, says Hyderabad-based vaccine maker

Hyderabad-based vaccine maker Bharat Biotech International (BBIL), on Thursday said BBV152 (Covaxin), its whole-virion inactivated Covid-19 vaccine candidate, has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase 2 and 3 studies. It effectively means that the vaccine is safe for children.

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, however, cleared the vaccine for use in two-year-old children and above.

Bharat Biotech had conducted phase 2 and 3, open-label, multi-centre studies to evaluate the