Moderna today announced that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants.
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).
During the Phase 3, researchers plan to enroll 30,000 people across the U.S. It will be a randomized, placebo-controlled trial. The participants in the trial will be administered 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.
“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.” he added
Moderna previously reported promising results of the first study of the vaccine, showing it induced immune responses and was generally safe in a small number of people.
Moderna has promised to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021. The company has internal U.S. manufacturing capabilities and strategic collaboration with Lonza, Ltd.
Moderna is regarded among the two most promising coronavirus vaccine candidates are moving into the final stages of testing, and could be ready for wider use before year’s end if results are positive.
Moderna recently received another round of funding from the US government for $472 million, taking Moderna's total government funding to just under $1 billion.
Moderna uses a proprietary mRNA platform for vaccine developemnt. mRNA relies on the body’s own cells to produce viral proteins. Once injected into the body, the RNA slips into human cells and tells them to make virus-like proteins, in this case the “spike" protein on the surface of the coronavirus. If the vaccine works, those proteins then trigger the body to generate protective antibodies.
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