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Moderna Seeks FDA EUA for mRNA-1273 COVID-19 Vaccine After Phase 3 Data Indicates Efficacy of Over 94%

By HospiMedica International staff writers
Posted on 01 Dec 2020
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Moderna, Inc. (Cambridge, MA, USA) has requested an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its COVID-19 vaccine candidate after the primary efficacy analysis of the Phase 3 study of its mRNA-1273 vaccine confirmed the high efficacy observed at the first interim analysis.

Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273, Moderna’s COVID-19 vaccine candidate, involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe. The data analysis indicated 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 primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy was demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. The primary analysis was based on 196 cases, out of which 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%. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities.

A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group. The safety profile of the Phase 3 study of mRNA-1273 was as previously described. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose. In addition to requesting an EUA from the FDA, the company has also submitted an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency.

“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.”

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