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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.
“The panel approval is for the phase II/III trials under certain conditions,” an official privy to the matter confirmed, on the condition of anonymity.
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.
Currently, Pfizer-BioNTECH Covid-19 vaccine has been approved by US FDA for use on children between 12 and 15 years in the US.