Moderna Seeks FDA, EMA Authorization Following mRNA-1273 Analysis Showing Vaccine 94.1% Effective

Country: UNITED STATES | Region: ASIA & SOUTH PACIFIC, EU28, EUROPE, MIDDLE EAST, NORTH AMERICA | Type: Regulation | Keywords:#conditionalapproval #covid19 #ema #emergencyuseauthorization
#fda #moderna #mrna1273 #rollingreview #vaccine


PRICENTRIC BRIEF:
  • Moderna’s primary efficacy analysis of the Phase 3 COVE study of the company’s COVID-19 vaccine candidate mRNA-1273 conducted on 196 cases indicates a vaccine efficacy of 94.1%, the company announced
  • Moderna now plans to request Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA)
  • In addition, Moderna has initiated the rolling review process for mRNA-1273 with EMA, Health Canada, Swissmedic, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), Israel’s Ministry of Health, and Singapore’s Health Sciences Authority

THE DETAILS

CAMBRIDGE, Massachusetts, The United States – Moderna’s primary efficacy analysis of the Phase 3 COVE study of the company’s COVID-19 vaccine candidate mRNA-1273 conducted on 196 cases indicates a vaccine efficacy of 94.1%, the company announced.

Moderna now plans to request Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).

In addition, Moderna has initiated the rolling review process for mRNA-1273 with EMA, Health Canada, Swissmedic, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA), Israel’s Ministry of Health, and Singapore’s Health Sciences Authority.

Moderna is also seeking Prequalification and/or Emergency Use Listing (EUL) from the World Health Organization (WHO).

The Phase 3 COVE study was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

Today’s announced primary analysis was based on 196 cases—185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%.

Moderna will submit data from COVE to a peer-reviewed publication.

Stephane Bancel, CEO of Moderna, commented, “The 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 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.”

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