Govt panel recommends against allowing SII to conduct trial of Covovax on children

Prameyanews English

Published By : Prameya News Bureau | July 01, 2021 IST

New Delhi, July 1: An expert panel of the country's central drug authority has recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trial of COVID-19 vaccine Covovax on children aged 2 to 17 years. According to the sources, the Central Drugs Standard Control Organisation (CDSCO) has not approved SII's request to allow clinical trials of its second Covid19 vaccine in children. The SII applied to the Drugs Controller General of India (DCGI) on Monday seeking permission for conducting a trial of Covovax on 920 children, 460 each in the 12-17 and 2-11 age groups, at 10 sites. The Subject Expert Committee (SEC) on COVID-19 of CDSCO, which deliberated on the application, noted that the vaccine has not been approved in any country, a source said. It also recommended that the Pune-based company should submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children, the source said.

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