Moderna To File For Vaccine Use Authorization
Moderna announced that they will request Emergency Use Authorization for their Covid-19 vaccine from the U.S. Food and Drug Administration [FDA] and conditional approval from the European Medicines Agency [EMA] today.
A statement from the company said “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%.”
The Company also announced that they “plan 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].”
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”
The company added, “Today, Moderna will submit for an EUA with the U.S. FDA and an application for Conditional Marketing Authorization [CMA] with the European Medicines Agency.
“The Company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency [MHRA], Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification [PQ] and/or Emergency Use Listing [EUL] with the World Health Organization [WHO].
“By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 available in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.”
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