U.S. begins final tests of coronavirus vaccine candidate
The vaccine was codeveloped by biotechnology company Moderna, Inc., based in Cambridge, Massachusetts, and the National Institute of Allergy and Infectious Diseases (NIAID).
The trial will be conducted at 89 U.S. clinical research sites with adult volunteers who do not have coronavirus, according to the statement.
NIAID Director Anthony Fauci said results from earlier clinical testing indicated that the vaccine was "safe and immunogenic, supporting the initiation of a Phase 3 clinical trial."
"This scientifically rigorous, randomized, placebocontrolled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last."
The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a governmental program that aims to begin delivering millions of doses of an effective virus vaccine by the end of 2020.
The trial is designed to determine if the vaccine can prevent symptomatic COVID-19 after two doses and it aims to study whether the vaccine can prevent severe infection with or without disease symptoms, the NIH said.
It also seeks to answer whether the vaccine can prevent death caused by the virus and if just one dose can prevent symptomatic COVID-19, among other objectives.
Trial volunteers will receive two injections approximately 28 days apart and some participants will be assigned at random to a control group that will be administered placebo doses. ■