Moderna has announced plans to distribute its COVID-19 vaccine to adolescent participants for the first time during its Phase 2/3 study.
The company announced individuals between the ages of 12 and 17 will be part of a study conducted in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to test the safety and effectiveness of its vaccine, WCVB reports.
“We are pleased to begin this Phase 2/3 study of mRNA-1273 in healthy adolescents in the U.S. 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,” said Stéphane Bancel, chief executive officer of Moderna via WCVB.
The Cambridge, Massachusetts-based pharmaceutical company plans to enroll 3,000 adolescent participants in the study, which will evaluate two vaccinations given 28 days apart, WCVB reports.
Last month, Moderna announced its plan to apply for authorization to the United States Food and Drug Administration Monday and the European Medicines Agency, asking both to review an expanded data set showing its vaccine's 94.1% effective rate at preventing COVID-19 and 100% effective rate at preventing severe cases of the virus, CNN reports.
The FDA is scheduled meet with the advisory committee to review both Pfizer and Moderna's applications in December, CNN reports. The United States is expected to see its first COVID-19 vaccinations take place "towards the latter part of December," according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, via CNN.
Moderna released updated data or its Phase 3 clinical trial in November, which showed only 11 participants among a total of approximately 15,000 individuals who received the vaccine in the study developed COVID-19. A total of 185 among the 15,000 individuals who received the placebo developed COVID-19.
None of the 11 individuals who received the vaccine and developed COVID-19 experienced severe cases, however, 30 of the 185 individuals who received the placebo developed severe cases, including one who later died.
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