Moderna To Seek ‘Emergency Use Authorisation’ From US And European Regulators For Covid-19 Vaccine, Efficacy At 94.1%

Moderna Inc announced today that it would ask U.S. and European regulators today (Nov 30) to allow emergency use of its COVID-19 vaccine after it was shown to be 94.1% effective in a full analysis of a pivotal study.

Moderna, Inc. also that 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%.

The company said that it 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. 196 subjects developed Covid-19 with symptoms after receiving either the vaccine or a placebo, Moderna said. Of those, 185 had taken a placebo, while only 11 had gotten the vaccine, indicating it protects against the disease resulting in a point estimate of vaccine efficacy of 94.1%, the company said.

The only people who got severely ill — 30 participants, including one who died — had received dummy shots, said Dr. Tal Zaks, the Cambridge, Massachusetts, company's chief medical officer.

The Phase 3 study was 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 reported 30 severe cases -- all in the placebo group -- which means the vaccine was 100% effective in preventing severe cases.

Moderna also said that efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

Moderna’s vaccine uses a gene-based technology known as messenger RNA after the molecules that carry DNA instructions for making proteins.

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.