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Permission denied to Serum to conduct Covovax trials in children

Permission denied to Serum to conduct Covovax trials in children

New Delhi: The expert committee assigned to standardise Covid-19 vaccines has recommended against the clinical trial of Covid-19 vaccine Covovax on children aged 2-17.

The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended against granting permission and pointed out that Covovax hasn't been approved by any other nation.

The committee also recommended that the Serum Institute submit a compiled data of safety and immunogenicity of Covovax from the clinical trial being conducted in adults. Its efficiency against the Delta variant is yet to be ensured.

The clinical trials of Covovax for adults began in March. The Serum Institute is planning to launch the vaccine in September.

The recommendations of the expert committee have been approved by the DCGI.

The creator of the vaccine, Novavax, had announced Covovax demonstrated 100% protection against moderate and severe infection. It also exhibited 90.4% efficacy in its Phase 3 trial. The American pharma major is likely to receive approval for Covovax in India by September.

The Serum Institute of India had applied to the Drugs Controller General of India (DCGI) seeking permission to conduct a trial on 920 children. 460 children were chosen to be in each age group - 2-11 and 12-17. 10 sites had been selected for the trials.

Bharat Biotech's Covaxin and Zydus Cadilla's ZyCov-D have already received approval to conduct clinical trials in children.

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