The First Phase 3 Vaccine Trial Begins in the U.S - COVID-19 Clinical Trial
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The First Phase 3 Vaccine Trial Begins in the U.S

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    On Monday, July 27, America’s first Phase 3 clinical trial of a coronavirus vaccine officially began.  

    The investigational vaccine being studied was developed in partnership by The National Institute of Allergy and Infectious Diseases and the biotechnology company Moderna. As one of 25 vaccine clinical trials currently in progress around the world, all eyes are on the Moderna/NIH study with the hope that an end to the pandemic may soon be in sight. 

    “Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial,” explained NIAID Director Anthony Fauci. “This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.” 

    How did Moderna Reach Phase 3 So Quickly? 

    Moderna is one of several pharmaceutical and biotech companies receiving support from Operation Warp Speed.  

    The federal government announced the creation of Operation Warp Speed in May, describing it as a national program designed to “accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.” 

    Operation Warp Speed uses a public-private partnership framework by encouraging biotech and pharmaceutical companies to collaborate with the CDC, FDA, NIH, BARDA, and other valuable federal agencies. This made it possible for Moderna to receive a total of $955 million in funding from BARDA, $472 million of which was used specifically for the Phase 3 study and development of Moderna’s vaccine.  

    What is Moderna’s Investigational Vaccine? 

    According to the NIH, Moderna’s investigational vaccine “directs the body’s cells to express the spike protein to elicit a broad immune response” against COVID-19. Phase 1 and 2 clinical trials found mRNA-1273 vaccine to be safe and able to induce antibodies with strong virus-neutralizing activity.   

    How Will Phase 3 Be Performed? 

    Moderna’s Phase 3 clinical trial will be conducted at 100 research sites across the United States. The first patient, for example, was dosed at a site in Savannah, Georgia. About 30,000 healthy adult volunteers are expected to participate in the trial. 

    Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart. Neither participants nor investigators will know who has received the vaccine compared to the placebo. 

    The ultimate goal of Moderna’s Phase 3 trial is to determine if the vaccine can prevent symptomatic COVID-19 after two doses. Researchers will all study the data to find whether mRNA-1273 can prevent severe COVID-19 or laboratory confirmed SARS-CoV-2 infection with or without disease symptoms. 

    Dr. Anthony Fauci said he expects enrollment to be finished by the end of the summer, with the first data readouts available by November.  

    Sources

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