According to a release by the National Institute of Allergy and Infectious Diseases [NIAID] the Moderna mRNA-1273 vaccine will enter Phase 3 clinical trials.

The vaccine was developed by NIAID scientists using technology developed by Moderna Inc based in Cambridge, MA. The vaccine comprises mRNA-1273 encoding for S-2P immunogen that stimulates antibodies to the SARS-CoV-2 spike protein. Phase 1 and 2 clinical trials demonstrated safety and the ability to stimulate virus-neutralizing antibody.

It is anticipated that 15,000 volunteers will receive two intramuscular injections approximately 28 days apart.  A control group of 15,000 volunteers will receive a saline placebo.  The trial is double blinded, so neither investigators nor participants will know to which group they are assigned.

Dr. Antony S. Fauci, Director of NIAID, stated “We urgently need a safe and effective preventive vaccine to ultimately control this pandemic.”  He added, “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.”

Dr. Francis S. Collins, Director of the National Institute of Health, stated “The launch of this Phase 3 trial in record time, while maintaining the most stringent safety measures, demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity towards a common goal.”

The Phase 3 trial will be implemented and monitored by specialists at the Baylor College of Medicine in Houston, the Harvard HIV Vaccine Clinical Trials Unit at Brigham and Women’s Hospital in Boston and by Meridian Clinical Research.

An independent safety monitoring board will review blinded and unblinded data, including safety and the incidence of COVID-19 in both vaccinated and control groups at regular intervals.

Parallel trials are underway in the EU on a similar vaccine developed independently by the University of Oxford in collaboration with Astra-Zeneca.