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Candidate COVID-19 Vaccine Undergoing Phase-One Evaluation

03/18/2020

A phase-one clinical trial to demonstrate the safety of an investigational COVID-19 vaccine has commenced in Seattle.  The project is funded by the National Institute of Allergy and Infectious Diseases (NIAID).  Kaiser Permanente Washington Health Research Institute is conducting the trial involving 45 healthy adult volunteers 18 to 55 years of age.  The vaccine mRNA-1273 was developed by the National Institutes of Health in collaboration with Moderna Inc., located in Cambridge, MA. 

 

Dr. Anthony S. Fauci Director of the NIAID stated “Finding a safe and effective vaccine to prevent infection with SARS-CoV-2, the causal agent of COVID-19, is an urgent public health priority.”  He added, “This phase-one study, launched in record speed, is an important first step towards achieving that goal.”

 

Following the release of the genome of SARS-CoV-2, scientists at Moderna developed the candidate vaccine targeting the spike protein of the virus and the product is based on messenger RNA that stimulates expression of a viral protein that will elicit an immune response. Moderna previously worked on experimental vaccines for SARS and MERS, which are also caused by coronaviruses. 

 

Study subjects will receive two doses of the vaccine by intramuscular injection 28-days apart.  Low and high doses of vaccines will be compared and the immune response of subjects will be assayed.  Unlike animal experiments, phase-one human trials determine safety and proof of concept and  do not involve challenge as in animal models.