The FDA and CDC have now made crystal clear that their promise of transparency with regard to COVID-19 vaccines was hogwash. As everyone now knows, the FDA has asked a federal judge to give it at least 75 years to produce the pre-authorization/licensure safety data. And we now know with certainty, federal health authorities similarly want to hide the post-authorization/licensure safety data.
The FDA and CDC have admitted their existing safety monitoring program, VAERS, was incapable of determining causation and therefore unreliable. The CDC has therefore deployed a new safety monitoring system for COVID-19 vaccines called v-safe, and now claims that these “vaccines are being administered under the most intensive vaccine safety monitoring effort in U.S. history.”
V-safe is a smartphone app that allows vaccine recipients to “tell CDC about any side effects after getting the COVID-19 vaccine.” The purpose of the app “is to rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting.” Data submitted to v-safe is “collected, managed, and housed on a secure server by Oracle,” a private computer technology company. Although the CDC has “access to the individualized survey data,” Oracle can only access “aggregate deidentified data for reporting.” Meaning, based on the CDC’s own documentation, the data submitted to v-safe is already available in deidentified form (with no personal health information) and could be immediately released to the public.
ICAN, through its attorneys, therefore asked in three FOIA requests that the CDC produce the deidentified data from the v-safe program in the same form in which Oracle can currently access it. The agency acknowledged that “v-safe data contains approximately 119 million medical entries” but denied producing that data because the “information in the app is not de-identified.” The CDC had apparently not read its own documentation regarding v-safe. But ICAN’s attorneys had and so they administratively appealed this decision and, at the same time, to leave no doubt what was being requested, submitted another request to the CDC that sought all data deidentified after it was submitted to the v-safe app (in other words, in the form that the agency made known that Oracle has the data). Incredibly, the CDC administratively closed this request stating it was duplicative of the original request.
Meaning, the first request was denied by the CDC because the CDC claimed it requested data that was deidentified when entered into the app, but then the CDC closed the second request (which was identical to the first request except for making clear it was seeking data deidentified at any point – before or after it was entered into the app) by claiming the second request was duplicative of the first request! The CDC is plainly playing games. It clearly does not want the v-safe data released.
The public should have immediate access to all v-safe data in deidentified form. Despite the fact that this deidentified data already exists, that it is already in the hands of a private company, and that the CDC has never objected to its production, the CDC has so far failed to produce it to ICAN or to the American public – the same people being mandated to take this liability-free product. But don’t worry, ICAN will not rest until this data is made public and so today has commenced a lawsuit against the CDC and HHS demanding that a court compel them to release this data.
You can read this lawsuit here. Thank you for your support!
