Moderna announced that its mRNA-1273 Covid-19 vaccine candidate has shown a significant effect against Covid-19 patients in phase 3 COVE study.
The independent and NIH-appointed Data Safety Monitoring Board (DSMB) revealed that the mRNA-1273 candidate has demonstrated an efficacy rate of 94.5% in the first interim analysis of the study.
The mRNA-1273 is an mRNA vaccine against Covid-19 encoding for a prefusion stabilised form of the spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Centre.
Moderna is conducting the trial in partnership 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 US Department of Health and Human Services.
The phase 3 COVE trial is a randomised and 1:1 placebo-controlled study evaluating mRNA-1273 at the 100µg dose level in 30,000 participants in the US aged 18 and older.
According to the company, the primary endpoint is the prevention of symptomatic Covid-19 disease and major prevention of severe Covid-19 disease and prevention of infection by SARS-CoV-2.
Moderna CEO Stéphane Bancel said: “This is a pivotal moment in the development of our Covid-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible.
“All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”
In May this year, Moderna first announced that its mRNA-1273 vaccine candidate against novel coronavirus demonstrated a significant effect in an early human trial.