Expert Panel Against Permitting Serum Institute To Conduct Trials Of Covovax On Children

An expert panel on COVID-19, of the Central Drugs Standard Control Organisation (CDSCO), has recommended against granting approval to the Serum Institute of India (SII) to conduct the Phase 2 and 3 trial of the vaccine Covovax on children aged between two and 17.

The vaccine manufacturer had applied to the Drugs Controller General of India (DCGI) for conducting a trial of Covovax on 920 children, 460 each in the age groups of 2-11 and 12-17 at 10 different sites, reported Times Of India.

Vaccine Not Approved

The panel stated that the vaccine has not been approved in any country and hence objected to its trials on children.

"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country. 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," a source said, reported The Times of India.

According to reports, the DCGI has approved the recommendations.

Agreement With Novovax

The US-based vaccine manufacturer Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID vaccine candidate, in low and middle-income countries and India in November.

The clinical trials of Covovax began in India in March and the SII hopes to launch it by September for adults.

In January, the SII had rolled out the Covishield vaccine in the country. It had entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.

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