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SII to conduct clinical trials of Novavax for children

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New Delhi, June 17, 2021 (Agency) The Serum Institute of India is likely to launch clinical trials of the Novavax Covid-19 vaccine for children in July, sources said.

SII is likely to introduce the Novavax vaccine, to be known as Covavax in the country, by September.

This week Novavax Inc announced that its vaccine has turned out to be more than 90 per cent effective in clinical trials conducted in the US.

Bharat Biotech has already begun clinical trials of Covaxin for children in the 6-12 age group.

Novavax Inc had announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial.

The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by Covid-19.

The company intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.

Upon regulatory approvals, Novavax remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.

“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile,” said Gregory M. Glenn, President of Research and Development, Novavax.

“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent Covid-19 amid ongoing genetic evolution of the virus,” Glenn added.

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