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Serum Institute to start Novavax trials in adolescents next month

Our Bureau Mumbai | Updated on June 17, 2021

In talks with DCGI to understand the protocols to conduct bridging trials

Serum Institute is hopeful of beginning trials on the Novavax Covid-19 vaccine in the 10 to 17 age groupfrom next month.

The vaccine-maker is in talks with the Drug Controller General of India to understand the protocols to conduct what will most likely be bridging trials on the vaccine in adolescents, an industry insider told BusinessLine.

Bridging trials

Serum has an alliance with the American biotech company to make and market the Novavax vaccine in India and other low- and middle-income countries. In fact, Serum collaborates with the Indian Council of Medical Research (ICMR) in the development of Covovax (as the Novavax vaccine is called), Serum and ICMR had said last November. Serum is presently undertaking bridging trials on this vaccine in India and expects to complete it by September.

Efficacy of vaccine

The development comes even as Novavax had recently claimed its vaccine’s over 90 per cent efficacy in protecting against virus variants.

In a statement early last month, Novavax had said that it was going to evaluate the efficacy, safety and immunogenicity of its vaccine in up to 3,000 adolescents, aged 12-17, across 75 sites in the US. Globally, Pfizer has an authorised Covid-19 vaccine for adolescents and Moderna is seeking emergency approval in the US.

In India, Bharat Biotech’s Covaxin is said to have commenced paediatric trials, in the 6-12 years age group, from this week.

The need for child vaccines comes even as discussions centre around getting children back to school and concerns emerge on the next surge of the virus possibly affecting children.

Published on June 17, 2021

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