Serum Institute to Seek DCGI Nod for Trials of Covovax on Children
Covovax is the Indian version of US-based Novavax, which is currently being developed and manufactured by SII.
Pune-based Serum Institute of India said it will apply for permission from the Drug Controller and General of India (DCGI) to conduct clinical trials of the Covovax COVID-19 vaccine among children.
Covovax is the Indian version of the US-based Novavax, which is currently being developed and manufactured by the SII.
SII CEO Adar Poonawalla on Friday tweeted: “A new milestone has been reached. This week we began our first batch of Covovax (a COVID-19 vaccine developed by Novavax). Excited to witness the first batch of Covovax being manufactured at our facility in Pune.This vaccine has great potential to protect our future generations below the age of 18. Trials are ongoing. (sic)"
“We plan to begin the paediatric trials in 920 children across 10 sites next month after seeking permission from the Drug Controller General of India (DCGI),” Poonawalla later told TOI.
On 16 June, Novovaxin announced that its vaccine had turned out to be more than 90 percent effective in clinical trials conducted in the US.
Meanwhile, 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 percent protection against moderate and severe disease, 90.4 percent 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.
Gregory M Glenn, president of Research and Development, Novavax said, "The high levels of efficacy reaffirm the ability of the vaccine to prevent COVID-19 amid the ongoing genetic evolution of the virus"
(With inputs from IANS and The Indian Express)
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