The Serum Institute of India(SII) is likely to launch clinical trials of the Novavax Covid-19 vaccine on children in July.
Sources revealed that the SII could launch the clinical trials next month where it is likely to introduce the Novavax vaccine, which would be known as ‘Covavax’ in the country, by September.
This week, Novavax Inc announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, showed 90.4 percent efficacy in the clinical trials in the US and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The vaccine demonstrated 100 percent protection against moderate and severe disease.
Gregory M. Glenn, president of Research and Development, Novavax, said,” PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile”. “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.
The study enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate the efficacy, safety, and immunogenicity, with a focus on recruiting a representative population of communities and demographic groups most affected by Covid-19.
The company intends to file for regulatory authorisations in the third quarter, on completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing, and controls (CMC) requirements.
Upon regulatory approvals, Novavax could 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.
Meanwhile, Bharat Biotech has already begun clinical trials of Covaxin for children in the 6-12 age group.