Moderna, NIH Begin Phase 3 Trial for their COVID-19 Vaccine
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The National Institutes of Health (NIH) and Moderna announced on 27 July that they have started a Phase 3 clinical trial, called the COVE (Coronavirus Efficacy) study, for their investigational vaccine for COVID-19.

The vaccine, known as mRNA-1273, was co-developed by NIH and Moderna. The trial will be conducted at US sites and is expected to enrol approximately 30,000 adults who do not have the virus.

“Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of Phase 3 clinical trial," National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, MD said.

Aim of the trial:

~ To Evaluate the safety of mRNA-1273 and determine if the vaccine can prevent symptomatic COVID-19 after two doses.

~ To study whether the vaccine can prevent severe COVID-19 with or without disease symptoms.

~ If the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19.

Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 micrograms (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.

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