Moderna Makes Full Study Protocol Document Public; Reports 25,000 Enrolled In Phase III Clinical Trial...

This is truly encouraging -- both for its transparency, and for the non-hyped, "solid science only" reporting on the mRNA vaccine candidate's progress. [In addition, a short "plain English" video has been made available -- see it at the bottom of this post.]

Here's a bit -- and here is the full study protocol, as a 120 page PDF file -- but do read everything, in the full press kit -- if you want to be fully-informed:

. . .COVID-19 vaccine (mRNA-1273):

As of Wednesday, September 16, 2020, 25,296 participants have been enrolled in the Phase 3 COVE study and approximately 28% of participants enrolled cumulatively are from diverse communities. 10,025 participants have received their second vaccination. The protocol for the study being conducted in collaboration with the NIH and BARDA is now publicly available. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study evaluating a two-dose vaccination schedule of mRNA-1273 across three dose levels (25, 100, 250 µg) in 45 healthy adults ages 18-55 years was published in The New England Journal of Medicine and shows mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.

mRNA-1273 was generally safe and well tolerated with no SAEs reported through Day 57. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034. . . .

[Note specifically that no projected FDA approval date is mentioned.] As I say -- this is how to build public confidence -- in a novel vaccine. Not fantastically-preposterous bluster -- from a Tangerine-hued, would be Mussolini.



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