Moderna plans to send its COVID-19 vaccine to United States and European regulators in an effort to allow emergency use amid the ongoing COVID-19 pandemic.
The Massachusetts-based pharmaceutical company 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.
"This is striking," said Dr. Paul Offit, a member of the FDA's vaccine advisory committee. "These are amazing data."
Moderna will become the second pharmaceutical company to apply to the FDA for emergency use authorization for a COVID-19 vaccine, joining Pfizer, which applied on November 20 after its tests on its COVID-19 vaccine also revealed high effective rates.
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 on Monday, 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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