ICAN UPDATE: Moderna Phase 1 Clinical Trial Data

Important news from the Informed Consent Action Network (ICAN)

After months of objections, the National Institutes of Health (NIH) and Moderna have capitulated and provided ICAN a copy of their internal 322-page Safety Summary Report and now over 700 pages of the Appendices to that report, for the Phase I trial of their COVID-19 vaccine (mRNA-1273). A full copy of this report and its appendices is available below and this is the first time it is being made available to the public.

We shared a few weeks ago that ICAN received the first 332 of over 1,000 pages of Moderna’s safety data from its Phase I trial, which it stated in its press release was “positive interim clinical data” that “substantiate[d] [their] belief that mRNA-1273 has the potential to prevent COVID-19 disease.”

ICAN has now received the complete report which contains an additional 714 pages of Appendices. It can be downloaded here. ICAN and its subscribers are the first people in the world, outside of NIH and Moderna, to actually see this data. Like last time, we will be carefully studying all of the disclosed data but ICAN wanted to widely disseminate it immediately so that others have the opportunity to do the same.

This report and its appendices were produced to ICAN in response to ICAN’s original FOIA request, and resulting litigation, for: “All safety and efficacy data and information regarding mRNA-1273, including from the Phase I clinical trial of this experimental vaccine conducted by the National Institute of Allergy and Infectious Diseases.”

What ICAN has received provides important information for the public to know in evaluating Moderna’s vaccine, which just this week was claimed to be 94.5% effective. The Appendices contain, among other things, a breakdown of all local and systemic adverse events and categorize them as mild, moderate, and severe.

ICAN’s legal team are still seeking additional documents responsive to its original request as this report and its appendices do not address efficacy (only safety) despite Moderna’s initial press release comments about efficacy. ICAN will also challenge some of the redactions made within the document.

ICAN will never rest in its fight to expose the truth regarding these products or in demanding full transparency and full informed consent for any and all vaccines, especially as we get closer to these manufacturers seeking FDA authorization or licensure for these experimental COVID-19 vaccines.

Phase 1 documents

Moderna Phase 1 Clinical Trial Description: https://www.clinicaltrials.gov/ct2/show/NCT04283461?term=mrna-1273&phase=0&draw=2&rank=1

Moderna Phase I Safety Summary Report: https://www.sec.gov/Archives/edgar/data/1682852/000119312518323562/d577473ds1.htm

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