Covaxin trials approved in children between 2 and 18 years

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.

Covaxin is the first Make in India Covid-19 vaccine that Bharat Biotech co-developed with the Indian Council of Medical Research (ICMR). It is a whole virion inactivated vaccine.

Bharat Biotech had approached the national drugs regulator with a proposal to test its Covaxin vaccine on children between 5 and 18 years of age, but the company was asked to come back with the efficacy data of its vaccine in adults first before testing the vaccine on children.

It was also asked to submit a revised clinical trials protocol for children in the SEC meeting of CDSCO on February 24.

As part of the SEC recommendation, the company has been asked to submit the interim safety data of phase II clinical trials along with the data safety and management board recommendations to the CDSCO before it intends to proceed to seek permission for the phase III part of the trials.