Trial | COVID
-19) is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.
The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.
Total of 200 million doses ordered by the
U.S government to date;
Approximately 20 million doses will be delivered by the end of
December 2020
U.S. licensure in 2021
CAMBRIDGE, Mass. (BUSINESS WIRE) Dec. 18, 2020
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced that the
U.S. Food and Drug Administration’s (FDA) has authorized the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is now authorized for distribution and use under an Emergency Use Authorization (EUA). Delivery to the
U.S. Government will begin immediately.
The way out : Trials in St. Louis helped build a 95% effective vaccine
Work persists at SLU, Washington University as first batches roll out
Scott Marion, smarion@edwpub.net
FacebookTwitterEmail
Dr. Sharon Frey, clinical director of St. Louis University’s Center for Vaccine Development, serves as the principal investigator of the COVID-19 vaccine trials at SLU.St. Louis University photo
ST. LOUIS With the first batches of the COVID-19 vaccine rolling out this week across the United States, several researchers from the St. Louis area are part of the effort to end the pandemic.
Researchers at the St. Louis University Center for Vaccine Development and Washington University School of Medicine are participating in COVID-19 vaccine trials, with each school participating in different trials.