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The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) rejected the proposal of the Serum Institute of India (SII)'s request for the clinical trials for the coronavirus vaccine in children. The expert panel said that it has to examine more about the vaccine's safety and the results in adults before it can be used to be tested in children. Serum Institute of India inked a deal with USA-based Novovax Covid-19 vaccine Covovax. SII applied to the Drug Controller General of India and sought the approval for the second and third phase of trials of Covovax on children aged between 2 and 17 years in India. SII said that the trials would be conducted on 920 children. Out of these, 460 children will be aged between 2 and 11 years. The 460 are aged between 12 and 17 years.
Ten selected locations are finalized to conduct the trials. Covovax is yet to receive the regulatory approvals in any country. Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D are conducting trials in children in India. Serum Institute of India has been in plans to conduct the trials in the country on children in July. Adar Poonawalla, CEO of SII said that the vaccine is expected to be launched in September after the clinical trials will be completed. SII is currently in risk manufacturing of Covovax from last month. SII is manufacturing Covishield which is developed by Oxford University and AstraZeneca. This is one of the two vaccines of the country. SII also inked an agreement to share Covovax doses with the COVAX facility and they would be distributed among the countries with low and middle income.
By Siva Kumar