BARDA continues to partner with Moderna for the first Phase 3 clinical trial of a COVID-19 vaccine to start in the United States
BARDA is expanding an existing partnership with Moderna, Inc. to support the Phase 3 clinical trial of Moderna’s mRNA-1273 vaccine candidate for COVID-19. The additional funding will allow Moderna to increase the number of participants in its Phase 3 clinical trial to 30,000 to satisfy FDA efficacy and safety requirements as rapidly as possible. The trial is being conducted in collaboration with Moderna, BARDA, and the National Institute of Allergy and Infectious Diseases (NIAID) under Operation Warp Speed.
Moderna and NIAID collaborated to develop mRNA-1273 and to conduct a Phase 1 study under an NIH-Investigator New Drug Application (IND). Moderna, with support from BARDA, recently completed a Phase 2 study under Moderna’s own IND. The vaccine candidate received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in May. This additional funding supports the expansion of the Phase 3 clinical trial that could lead to FDA granting Emergency Use Authorization or licensure.
A safe, effective, and deployable vaccine is critical to ending the COVID-19 pandemic, mitigating future waves, and saving lives. The urgency to develop and deploy at least one safe and effective vaccine is critical to saving lives, protecting Americans, and reducing the economic impact from this pandemic. If the FDA authorizes or approves the mRNA-1273 vaccine candidate, it could be used in a COVID-19 vaccination campaign.
For more information on the Phase 3 trial, visit clinicaltrials.gov.
This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio and aligned with Operation Warp Speed; visit BARDA’s COVID-19 Portfolio to learn more.
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Moderna, Inc. is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators. Headquartered in Cambridge, Massachusetts, Moderna is a publicly traded company and employs more than 900 people.