Covaxin gets nod to begin clinical trials among children as young as 2

NEW DELHI Bharat Biotech has received approval from India’s drugs regulator to conduct clinical trials on children for its coronavirus disease (Covid-19) vaccine, Covaxin, making it the first Covid-19 vaccine to be tested on kids in India.

The approval has been granted for testing the vaccine on children between 2 and 18 years of age. The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Tuesday approved trials, with certain conditions, officials aware of the matter confirmed.

According to reports, the trial is planned to be conducted among 525 participants at multiple locations.

The hospitals include All India Institute of Medical Sciences (AIIMS), Delhi, and AIIMS in Patna.

The aim of conducting the trials will be to evaluate the Covaxin vaccine in children for safety, reactogenicity and immunogenicity. All these parameters are necessary for granting approval for use in masses.