The Serum Institute of India (SII) is set to start trials of Covovax Covid-19 vaccine (Novavax’s candidate) on children this month. The trials would cover 920 children, 460 each in the age-group of 12-17 and 2-11 across 10 sites.
Two Indian vaccine makers — Bharat Biotech (Covaxin) and Zydus Cadila (ZyCoV-D) — have already begun the paediatric trials.
According to a Business Standard report, Covovax has the efficacy of close to 90 per cent but is yet to be approved for use anywhere.
The development comes a week after an expert panel of Central Drug Authority recommended granting permission to SII for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.
“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) deliberated on the revised study protocol application given by SII on Tuesday and recommended granting permission to the firm for conducting phase 2/3 trial of Covovax on children aged 2 to 17 years,” a source had told News18 last week.
The Pune-based pharmaceutical company had submitted a revised protocol for inclusion of pediatric cohort in the ongoing Covovax phase 2 and 3 observer-blind, randomised, controlled study in Indian adults aged 18 years and above to determine the safety and immunogenicity of the jab.
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