Enrollment in the phase 3 COVE study investigating the vaccine candidate mRNA-1273 against coronavirus disease 2019 (COVID-19) has been completed, according to Moderna.
The randomized, placebo-controlled study now includes 30,000 participants. The trial is investigating the efficacy, safety, and immunogenicity of mRNA-1273 at the 100mcg dose (given intramuscularly in a 2-dose series, approximately 28 days apart) for the prevention of COVID-19 in adults aged 18 years and older.
Currently, the study includes more than 7000 US adults over the age of 65, as well as 5000 participants under the age of 65 living with high-risk chronic diseases such as diabetes, severe obesity, significant cardiac disease, and chronic lung disease. Additionally, in a statement, the Company noted the diversity of the study population, with 20% of participants identifying as Hispanic or Latinx and 10% of individuals identifying as Black or African American. To date, more than 25,650 participants have received their second vaccination.
The primary end point of the study is the prevention of symptomatic COVID-19 disease. Key secondary end points include the prevention of severe COVID-19 disease and prevention of infection by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Study data will be reviewed by an independent data safety monitoring board appointed by the National Institutes of Health. According to the Company, a request for Emergency Use Authorization is expected to be submitted to the Food and Drug Administration after a median safety follow-up of 2 months.
For more information visit modernatx.com.
Moderna completes enrollment of phase 3 COVE study of mRNA vaccine against COVID-19 (mRNA-1273). [press release]. Cambridge, MA: Moderna, Inc; October 22, 2020.