Moderna files for FDA emergency use authorization of COVID-19 vaccine following Phase 3 study

With 94.1 percent efficacy figures pulled from a phase three COVE study of its mRNA-1273 vaccine for COVID-19, Moderna, Inc. has officially filed for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA).

The study consisted of more than 30,000 participants and, at the time of its first interim analysis, had seen the vaccine used on 196 cases of COVID-19, of which 30 cases were severe. The vaccine itself proved generally well tolerated, without serious safety concerns, and in addition to its overall efficacy, touted a 100 percent efficacy against severe COVID-19 cases. The study was conducted in conjunction with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

“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,” Stéphane Bancel, CEO of Moderna, said. “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 study’s primary endpoint was based on the analysis of COVID-19 cases confirmed and assessed from a point two weeks after a second vaccine dose was issued. Among these, 185 of the 196 cases were produced in the placebo group, which granted the 94.1 percent efficacy rate. The secondary endpoint focused on severe cases, and the study confirmed that its 30 cases all emerged in the placebo group, rather than those given mRNA-1273.

The results were consistent across age, race, and ethnicity, as well as gender demographics. Most were restricted to injection site pain, fatigue, myalgia, arthralgia, headache, and redness at the injection site for those experiencing side effects.

Data from the study will be submitted to a peer-reviewed publication. The FDA has told Moderna to expect a Vaccines and Related Biological Products Advisory Committee meeting on its candidate this month. That committee will review the safety and efficacy data package for mRNA-1273 and make a resulting recommendation to the FDA. A rolling review process has already been initiated in numerous other countries, and Moderna intends to seek prequalification and/or emergency use listing with the World Health Organization.