The Central Drugs Standard Control Organisation (CDSCO) on Tuesday, May 11, approved Bharat Biotech’s Covid-19 vaccine, ‘Covaxin’ for phase II and III human clinical trials on people belonging to the age group 2 to 18.
Bharat Biotech’s Covaxin and Serum Institute’s Covishield, the vaccines approved in India have only been clinically tested on people above the age of 18. Covaxin would be the first Covid-19 vaccine to be tested on kids in India. It has been co-developed with the Indian Council of Medical Research (ICMR).
Where would the trials take place?
According to media reports, Bharat Biotech’s Covaxin has been approved for clinical trials, with certain conditions. The trials will reportedly be conducted among 525 participants at multiple locations including AIIMS, New Delhi, AIIMS, Patna and Nagpur-based Meditrina Institute of Medical Sciences.
According to the recommendations of SEC, Bharat Biotech will have to submit the report of Phase II before starting the trials for phase III on children.
Earlier, Bharat Biotech had proposed the national drugs regulator to test its Covid-19 vaccine, ‘Covaxin’ on children between 5 and 18 years of age. However, it was asked to furnish the efficacy data of its vaccine in adults 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.
Why are trials important?
Vaccines are tested to ensure that they are safe for use. The trials will ensure the safety, reactogenicity, and immunogenicity of the vaccine on children. When the vaccine clears these parameters, it would be approved for mass usage.
Currently, Pfizer-BioNTECH Covid-19 vaccine has been approved by US FDA for use on children between 12 and 15 years in the US.
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