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Wednesday, March 3rd, 2021

Late-stage trial of Moderna, NIAID COVID-19 vaccine gets underway

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At sites across the United States, a phase 3 trial of the investigational vaccine mRNA-1273, jointly developed by Moderna, Inc. and the National Institute of Allergy and Infectious Diseases (NIAID) is set to enroll 30,000 volunteers for testing.

Anyone 18 years of age and older, who does not presently have COVID-19, is applicable to enroll. Moderna will lead the trial and is providing the vaccine for it, while the Biomedical Advanced Research and Development Authority (BARDA) will provide funding support.

It stands to be a watershed moment for efforts to combat COVID-19 in the U.S., as this will mark the first vaccine efficacy trial to be conducted under the federal Operation Warp Speed.

“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” NIAID Director Dr. Anthony Fauci said. “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. 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.”

NIAID developed the stabilized spike immunogen for SARS-CoV-2, the virus which causes COVID-19. The spike protein is on that virus’s surface, allowing it entry into cells. The mRNA-1273 vaccine urges cells to express that protein as a means of provoking a wide immune response.

A phase 2 trial is still underway, but a phase 1 clinical trial deemed the vaccine safe, well-tolerated and effective at inducing antibodies.

“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” NIH Director Dr. Francis Collins said. “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 toward a common goal.”

Guiding the trial will be Drs. Hanna El Sahly, principal investigator of the Infectious Diseases Clinical Research Consortium site at Baylor College of Medicine in Houston, Lindsey Baden, principal investigator of the Harvard HIV Vaccine Clinical Trials Unit at Brigham and Women’s Hospital in Boston, and Brandon Essink, principal investigator and medical director of Meridian Clinical Research.

The trial has several goals. It will evaluate: the vaccine’s safety and prevention capabilities from two doses; the ability to prevent severe COVID-19 or lab-confirmed SARS-CoV-2 infection with or without symptoms; whether the vaccine can prevent COVID-19 induced deaths and if a single dose can prevent symptomatic COVID-19.