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American biotechnology company Novavax Inc. had recently announced that its Covid-19 vaccine, called NVX-CoV2373, showed more than 90 per cent effectiveness in clinical trials conducted in the US. The Serum Institute of India will be conducting clinical trials to evaluate the safety and efficacy of the Novavax Covid-19 vaccine in children. According to media reports, the Indian company is likely to launch clinical trials in next month (July). If all goes well, the Novavax vaccine, to be known as Covavax in the country, is expected to be launched by September.
NVX-CoV2373 is a recombinant nanoparticle protein-based Covid-19 vaccine. This week, Novavax announced the results of its PREVENT-19 pivotal Phase 3 trial, which found that the vaccine demonstrated 100 per cent protection against moderate and severe disease and 90.4 per cent efficacy overall. Novavax plans to file for regulatory authorisations in the third quarter of 2021, after which it aims to reach a manufacturing capacity of 150 million doses per month by the end of the fourth quarter.
It is to be noted that Hyderabad-based Bharat Biotech has already begun clinical trials of its Covid-19 vaccine 'Covaxin' for children in the 6-12 age group.
The United Kingdom (UK), Canada, the US, and the EU have already approved Pfizer/BoiNTech coronavirus vaccine for use in children as young as 12. The vaccine was initially authorized for people aged 16 and older. Earlier Pfizer had released data suggesting that its vaccine is well tolerated in adolescents and highly effective in preventing COVID-19.
Commenting on the approval of Pfizer/BoiNTech vaccine for use in children in the UK, June Raine, chief executive of the MHRA said, "We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech Covid-19 vaccine is safe and effective in this age group and that the benefits of this vaccine outweigh any risk."
Last month, Moderna also announced that its Covid-19 vaccine is safe and highly effective in children ages 12 to 17. The vaccine is currently authorised for adults 18 and older in the US. The company was planning to submit its teen data to the US Food and Drug Administration and other global regulators for emergency use authorisation in early June. The authorisation for use in adolescents is expected to come in early July. Previous clinical trials showed the vaccine, which is given as two doses four weeks apart, to be around 95 percent effective in preventing symptomatic illness in adults. In March, the company began clinical trials of its vaccine in children ages 6 months to 11 years old.
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