Primary efficacy analysis of the phase 3 COVE study of mRNA-1273 involving 30,000 participants has included 196 cases of COVID-19, of which 30 cases were severe
Moderna, a biotechnology company pioneering messenger RNA ( mRNA ) therapeutics and vaccines to create a new generation of transformative medicines for patients, has announced that the primary efficacy analysis of the phase 3 study of mRNA-1273 conducted on 196 cases has confirmed the high efficacy observed at the first interim analysis.
The data analysis has 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 phase 3 study, known as the COVE, enrolled more than 30,000 participants in the U.S. and is being 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.
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 has been demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion.
The new primary analysis was based on 196 cases, 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%.
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.
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 ).
The safety profile of the phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified.
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.
The COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older.
The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.
The COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of more than 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of severe complications of COVID-19 disease.
The COVE study has included more than 7,000 Americans over the age of 65. It also has included more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the COVE study.
The study has also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19.
The study has included more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. ( Xagena )
Source: Moderna, 2020