Moderna Begins Dosing in Phase 3 Study of mRNA COVID-19 Vaccine Candidate

Moderna, Inc. (Cambridge, MA, USA) has begun dosing in the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19.

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 US Department of Health and Human Services. Moderna is working closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under the auspices of Operation Warp Speed.

The Phase 3 study protocol follows the US Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies. The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the US for 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.

The primary efficacy analysis of the Phase 3 study will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. To ensure the ongoing safety monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by NIAID throughout the study. Moderna remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.

“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.”

Separately, Moderna’s contract with the BARDA has been modified for an additional commitment of up to USD 472 million to support late stage clinical development, including the expanded Phase 3 study of the company’s mRNA vaccine candidate against COVID-19.

Moderna had entered into an earlier contract with BARDA for up to USD 483 million to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the FDA and consultations with Operation Warp Speed over the past several months, the company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding its support of the company’s late stage clinical development of mRNA-1273, including the execution of the 30,000 participant Phase 3 study in the US. The total value of the award is now approximately USD 955 million.

“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19,” said Bancel. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”

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