Moderna (MRNA) announced on Monday, July 27 that it had begun Phase III trials for its COVID-19 vaccine, a day following another announcement from the Company that it had received $472 million in additional funding from Biomedical Advanced Research and Development Authority (BARDA) to expand its clinical testing of the vaccine.
The Phase 3 study, called the COVE (Coronavirus Efficacy) study, 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 most recent round of BARDA funding brings the total US government funding to Moderna for the COVID-19 vaccine project to $955 million.
“We are pleased to have started the Phase 3 COVE study,” said Stephane Bancel, CEO at Moderna. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”
The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19.
With its collaborators, Moderna has selected nearly 100 clinical research sites with representative demography and is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study.
Pfizer also announced last week, along with its collaboration partner BioNTech, that it is began a large Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2. Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen.
“Today, we are starting our late-stage global study, which will include up to 30,000 participants. We selected BNT162b2 as our lead candidate for this Phase 2/3 trial upon diligent evaluation of the totality of the data generated so far. This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment.”