A primary efficacy analysis of the phase 3 trial evaluating the vaccine candidate mRNA-1273 against coronavirus disease 2019 (COVID-19) confirmed the vaccine’s high efficacy first reported in the interim analysis.
The randomized, placebo-controlled COVE study is investigating the efficacy and safety of mRNA-1273 at the 100mcg dose (given intramuscularly in a 2-dose series, approximately 28 days apart) in more than 30,000 adults aged 18 years and older. The primary efficacy end point of the trial is the prevention of symptomatic COVID-19 disease based on the analysis of cases confirmed and adjudicated starting 2 weeks after the second dose.
Results reported by an independent National Institutes of Health (NIH)-appointed Data Safety Monitoring Board (DSMB) showed that the vaccine was 94.1% effective based on 196 confirmed cases, of which 185 occurred in the placebo group and 11 occurred in the mRNA-1273 group. The data also included 30 severe cases, all of which were among participants in the placebo group. To date, there was one COVID-19-related death reported in the placebo group.
The safety profile of mRNA-1273 will be continuously monitored and reviewed by the DSMB. There were no new serious safety concerns reported in the primary efficacy analysis,with the most common solicited adverse reactions being injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
Among the 196 confirmed COVID-19 cases, 33 participants were adults aged 65 and older and 42 participants identified as being from diverse communities (including 29 Hispanic or Latinx, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants). The COVE trial includes more than 7000 US adults over 65 years old, 5000 participants under 65 living with high-risk chronic diseases (eg, diabetes, severe obesity, significant cardiac disease, chronic lung disease), 6000 participants who identify as Hispanic or Latinx, and more than 3000 participants who identify as Black or African American.
“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, CEO of Moderna.
Moderna will request an Emergency Use Authorization (EUA) for mRNA-1273 from the Food and Drug Administration (FDA) today. The Company will submit data from the COVE study to a peer-reviewed publication.
Additionally, a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will likely be scheduled for Thursday, December 17 to review the safety and efficacy data package for mRNA-1273. The Company expects to have approximately 20 million doses of the vaccine candidate available by the end of 2020.
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Moderna announces primary efficacy analysis in phase 3 COVE study for its COVID-19 vaccine candidate and filing today with U.S. FDA for Emergency Use Authorization. [press release]. Cambridge, MA: Moderna, Inc; November 30, 2020.