NIH/Moderna’s Covid-19 vaccine Phase 1 trial info released – reluctantly!

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 for the Phase I trial of their COVID-19 vaccine (mRNA-1273). A full copy of this report is available below and this is the first time it is being made available to the public.

On May 18, 2020, Moderna issued a press release claiming the data from its Phase I trial “substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease.” Since this trial was actually conducted by the NIH, ICAN submitted a FOIA request on May 22, 2020 to NIH 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.” ICAN requested that NIH grant expedited processing for this request.

On June 8, 2020, NIH recognized the “compelling need” to expeditiously release to the public the information ICAN sought by granting its request for expedited processing. But then NIH failed to produce anything. Therefore, ICAN sued the NIH on August 13, 2020 in federal court to force NIH to release this data. NIH then finally sent a “final response” to ICAN stating: “The safety data for this study comprises 1,093 pages. I have determined to withhold those records in their entirety pursuant to [exemptions that] protect information that constitutes trade secret information and information that is confidential and commercial or financial in nature.”

ICAN did not accept this objection and its attorneys, led by Aaron Siri, informed the court that we would argue for the documents via briefs to the court. NIH’s opening brief – explaining why it should not produce this data – was set to be due to the Court on October 30, 2020. Eight days before that due date, on October 22, 2020, NIH and Moderna abruptly reversed their position and advised that they would produce all of the data.

On October 29, 2020, ICAN received the first 332 of 1,093 pages — the remainder of which will be produced shortly. 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. 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.

Despite only receiving a portion of the data, what ICAN has already received provides important information for the public to know in evaluating Moderna’s vaccine. For example, the documents ICAN received reveal that approximately 70% of participants reported unsolicited adverse events, many of which are extremely concerning.

Just as the pharmaceutical companies will never rest when it comes to promoting and selling their vaccine products, we will never rest in exposing the truth regarding these products or in demanding full transparency and full informed consent for any and all vaccines.

Information obtained from http://www.ICANDecide.org

***UPDATE 11/24/2020***

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.

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.

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