Moderna Inc said on Thursday it had dosed the first participants in a mid-to-late stage study testing its COVID-19 vaccine candidate in adolescents aged 12 to less than 18, and aims for data ahead of the 2021 school year. The trial will enroll 3,000 healthy participants in the United States and will assess the safety and effectiveness of two doses of the company's vaccine candidate, mRNA-1273, given 28 days apart. Moderna has submitted applications seeking emergency use authorization (EUA) in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective in adults with no serious safety concerns. Rival Pfizer/BioNTech have also sought EUA after their coronavirus vaccine's two-dose regimen proved 95% effective against COVID-19 and had no major safety issues. Meanwhile, a panel of outside advisers to the U.S. Food and Drug Administration will meet on Thursday to discuss whether to recommend the use of Pfizer's vaccine for people aged 16 and older. A similar meeting of advisers to the FDA is scheduled for Dec. 17 to discuss Moderna's vaccine. Moderna's adolescents study is being conducted in collaboration with the Biomedical Advanced Research and Development Authority, a part of the U.S. Department of Health and Human Services. "Our goal is to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year," Chief Executive Officer Stephane Bancel said in a statement. Pfizer is also studying its vaccine candidate in participants as young as 12. —Reuters Staff Source
