The FDA Wants to Hide Pre-Licensure Data Until You’re Dead and Now the CDC Wants to Hide the Post-Licensure Safety Data
You must take this product. You cannot sue if injured. You can maybe see the clinical trial safety data in 75+ years. And the deidentified post-licensure safety data – no, you cannot see that either.
Three prior posts explained how the FDA seeks to delay for 75+ years full production of Pfizer’s pre-licensure safety data. While we have that fight, we submitted a request to the CDC, on behalf of ICAN, for the deidentified post-licensure safety data for the Covid-19 vaccines in the CDC’s v-safe system. Even though this data is available in deidentified form (meaning, it includes no personal health information), the CDC refused to produce this data claiming it is not deidentified.
So, on behalf of ICAN, we filed a federal lawsuit against the CDC and its parent entity, the U.S. Department of Health and Human Services (HHS), to force the CDC to produce this data to the public. The CDC should have no issue doing so because it has already made this data available to a private company – Oracle – in deidentified form. It is telling that Larry Ellison’s company can see the data American taxpayers paid the CDC to collect but the average American and independent scientists cannot?!
What is the v-safe system you may ask? Since rolling out the Covid-19 vaccines, the FDA and CDC have stated that their primary safety monitoring system, VAERS, is unreliable. The CDC therefore deployed a new safety monitoring system for COVID-19 vaccines called “v-safe.” 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.” With this new system, the CDC claims that these “vaccines are being administered under the most intensive vaccine safety monitoring effort in U.S. history.”
That all sounds great. And a CDC document explains that data submitted to v-safe is “collected, managed, and housed on a secure server by Oracle,” a private computer technology company, and that Oracle can access “aggregate deidentified data for reporting.” This means data submitted to v-safe is already available in deidentified form and could be immediately released to the public.
But yet, after we submitted a FOIA request to the CDC, on behalf of ICAN, to produce the deidentified v-safe data, the CDC acknowledged that “v-safe data contains approximately 119 million medical entries” but refused to produce that data by claiming that the “information in the app is not de-identified.” The CDC had apparently not read its own documentation regarding v-safe. But we had. So, we appealed this decision and submitted another request to the CDC that expressly asked only for any deidentified v-safe data, in the app or otherwise. Meaning, in the form that the CDC made the data available to Oracle. Incredibly, the CDC administratively closed this request stating it was duplicative of the original request.
Let me break that down again. The first request was denied by the CDC because it claimed the request sought data in the app that was deidentified. But then the CDC closed the second request, which made clear it is seeking only deidentified data (in the app or otherwise), by claiming the second request was duplicative of the first request! If this sounds ridiculous, it is because it is.
The public should be outraged by the CDC’s games.
The introduction to the lawsuit is copied below with a link to the entire complaint at the end. As with the pre-licensure Pfizer data, if you find what you are reading difficult to believe, that is because it is dystopian for the government to give pharmaceutical companies billions, mandate Americans to take their products, prohibit Americans from suing for harms, yet refuse to let Americans see the pre- and post-licensure safety data for these products. The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure.
INTRODUCTION TO LAWSUIT AGAINST CDC FOR V-SAFE DATA
1. Between December 2020 and February 2021, the Food and Drug Administration (“FDA”) issued Emergency Use Authorizations for three COVID-19 vaccines, one of which subsequently received FDA approval in August 2021. While the FDA approved these vaccines, the Centers for Disease Control and Prevention (“CDC”), an agency within the Department of Health and Human Services (“HHS”), is charged with monitoring the safety of all vaccines, including the COVID-19 vaccines approved by the FDA. The CDC claims that these “COVID-19 vaccines are being administered under the most intensive vaccine safety monitoring effort in U.S. history[.]”
2. The federal government has mandated that millions of Americans receive these vaccine products. HHS has also given pharmaceutical companies complete immunity for injuries caused by those products. Mandating that millions of Americans inject a product for which they cannot hold the manufacturer liable if the product injures them demands complete transparency, especially when it comes to releasing the data underlying the product’s safety. FOIA exists precisely so that the American people can obtain transparency and, in this case, obtain the data which supports the CDC’s claims to intensive safety monitoring.
3. As for the pre-licensure data submitted by the pharmaceutical companies, the FDA took the position in another FOIA action that, because it needs to deidentify that data, it needs at least 75 years to produce the data to the public. As for the post-licensure data, the FDA and CDC have said that their prior primary existing safety monitoring program was incapable of determining causation and were otherwise unreliable. The CDC has, however, deployed a new safety monitoring system for the COVID-19 vaccines, v-safe, and the data within v-safe is already available in deidentified form and could be forthwith released to the public.
4. 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 and to detect and evaluate clinically important adverse events and safety issues that might impact policy or regulatory decisions.”
5. 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.”
6. Plaintiff asked through its instant FOIA requests that the CDC produce the deidentified data from the v-safe program in the same form that Oracle can access. Plaintiff believes that to assure transparency regarding the government’s claim that COVID-19 vaccines are “safe and effective,” the public should have immediate access to all v-safe data, in deidentified form, and therefore, once the CDC produces that data, Plaintiff intends to make it publicly available. Despite the fact that the deidentified data already exists, it is already in the hands of a private company, and the CDC has never objected to its production, the CDC has so far failed to produce it to Plaintiff or to the American public. The federal government is thereby not only failing to provide the transparency necessary to earn the American people’s trust regarding these vaccines but is also failing to comply with FOIA.
7. Plaintiff Informed Consent Action Network (“Plaintiff”) is a non-profit organization that advocates for informed consent and full transparency and disseminates information necessary for same with regard to all medical interventions. It intends to make all v-safe data immediately available to the public so that independent scientists can immediately analyze that data. It believes that we need all hands on deck, both inside and outside the government, to address serious and ongoing issues with the vaccine program, including waning immunity, adverse reactions, etc. Locking out independent scientists from addressing these issues is dangerous, irresponsible, unethical, and illegal.
8. To acquire the v-safe data, Plaintiff made three requests to the CDC pursuant to the Freedom of Information Act (5 U.S.C. § 552, as amended) (“FOIA”) seeking information regarding v-safe.
You can read the entire complaint here: