After months of NIH objecting, and after seeking Court intervention, ICAN’s attorneys have won a motion which now forces the NIH to unredact and disclose safety-related data they tried to withhold from Moderna’s Phase 1 clinical trial report.
As a result of a Freedom of Information Act (FOIA) request, the National Institutes of Health (NIH) provided the Informed Consent Action Network (ICAN) a copy of an internal 322-page Safety Summary Report along with over 700 pages of Appendices to that report, detailing safety data from Moderna’s Phase I clinical trial for its and NIAID’s COVID-19 vaccine. This report was previously shared with ICAN supporters and was the first and only time we are aware of that this report was made public. It can be downloaded here.
After reviewing the report, ICAN challenged the redactions made within the document, explaining their importance to the public. NIH fought back but the Court, in its June 24, 2021 decision, ultimately ruled in ICAN’s and the public’s favor holding that the “NIH cannot articulate a sufficient privacy interest to justify redacting” the information that it did and that “the public interest in seeing the full data outweighs any individual privacy concerns” of the clinical trial participants. “The unredacted data will be provided within a few days and ICAN will immediately make it available so that everyone can see what information is being withheld from the public,” ICAN said.
ICAN also challenged the adequacy of the agency’s search and believes there are likely more responsive documents in NIH’s possession. To address this issue, ICAN has now filed additional FOIA requests to obtain copies of these documents, and any new productions will be shared. “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 these manufacturers seek FDA licensure for these experimental COVID-19 vaccines,” a spokesman added.
Actually, only 61 got two shots.
All participants are healthy, too.
— Guy Sela (@SelaReport) July 21, 2021