Moderna applies for FDA authorization for its Covid-19 vaccine

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Moderna today announced that the primary efficacy analysis of their Phase 3 study of their vaccine candidate, mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB).

Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and 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.

Moderna will become the second company to apply to the FDA for emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing similarly high efficacy.The FDA will meet with its advisory committee in December to review Pfizer’s and Moderna’s applications.The first vaccinations in the United States are expected to take place “towards the latter part of December,” according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.Moderna said it also plans to apply for authorization from the European Medicines Agency on Monday.

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