Moderna to file for emergency FDA approval of COVID-19 vaccine


Moderna, a biotechnology company has just announced the primary efficacy analysis in the Phase 3 COVE study for mRNA-1273, of their COVID-19 vaccine candidate and they plan to request an Emergency Use Authorization from the U.S. FDA & conditional approval from the EMA.

Moderna to file for emergency FDA approval in the race for a vaccine, the company says — the second leading drug to pass the milestone this month.

Just released additional data showing it is 94.1% effective at preventing covid19 and 100%     effective at preventing severe cases, with similar efficacy rates for elderly and minorities.

The biotechnology company is submitting a request to the US Food and Drug Administration for emergency use authorization and to the European Medicines Agency for conditional approval.

Moderna says it will ask U.S. and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirm the shots offer strong protection.

As per an official press release, Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of 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). The Company also announced that today, 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.


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