CDC Sued for Withholding Post-Licensure ‘V-safe’ Data on COVID-19 Vaccines

By Katabella Roberts
Katabella Roberts
Katabella Roberts
Katabella Roberts is a reporter currently based in Turkey. She covers news and business for The Epoch Times, focusing primarily on the United States.
December 31, 2021 Updated: January 4, 2022

The Centers for Disease Control and Prevention (CDC) has been sued by the Informed Consent Action Network (ICAN), which claims that the agency is improperly withholding COVID-19 vaccine safety data from the American public.

In a Dec. 29 statement, the nonprofit announced that it filed a lawsuit (pdf) against the CDC and the U.S. Department of Health and Human Services to force it to provide de-identified post-licensure safety data for the COVID-19 vaccines in the CDC’s v-safe system.

According to the CDC’s website, v-safe is an “active surveillance program to monitor the safety of COVID-19 vaccines during the period when the vaccines are authorized for use under Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and possibly early after vaccine licensure.”

Through the app, vaccine recipients can inform the agency about any side effects they’ve suffered after getting a COVID-19 vaccine. Currently, the CDC has made data from its v-safe system available to the private computer technology company Oracle in de-identified form, meaning that personal identifying information has been redacted.

This data “will be collected, managed, and housed on a secure server by Oracle,” according to the CDC (pdf).

“Through Health and Human Services (HHS), Oracle has donated IT services to any agency conducting COVID-19 related activities. … All data will be stored, processed, and transmitted in accordance with the Federal Information Security Modernization Act (FISMA) and based on NIST standards,” the agency’s website states.

However, ICAN wants the CDC to produce that same de-identified data to the general public to assure transparency regarding claims by both the CDC and the Biden administration that COVID-19 vaccines are “safe and effective.”

“The FDA and CDC have now made crystal clear that their promise of transparency with regard to COVID-19 vaccines was hogwash,” ICAN said in its Dec. 29 statement.

Epoch Times Photo
Protesters rally against vaccine mandates in New York on Nov. 20, 2021. (Stephanie Keith/Getty Images)
Epoch Times Photo
Syringes and vials of the Pfizer-BioNTech COVID-19 vaccine are prepared to be administered at a drive-up vaccination site from Renown Health in Reno, Nev., on Dec. 17, 2020. (Patrick T. Fallon/AFP via Getty Images)

The FDA has asked a judge to give it 75 years to produce data concerning the Pfizer and BioNTech vaccine, having previously asked the court to give it until the year 2076 to fully release the documents.

“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,” ICAN stated.

“Based on the CDC’s own documentation, the data submitted to v-safe is already available in de-identified form (with no personal health information) and could be immediately released to the public.”

The nonprofit, through its attorneys, asked in three Freedom of Information requests that the CDC produce the de-identified data, to which the health agency acknowledged (pdf) that “v-safe data contains approximately 119 million medical entries” but declined to produce it because the “information in the app is not de-identified.”

However, the third request was administratively closed (pdf) by the CDC, claiming that it was a duplicate of the original request, which was denied.

“The first request was denied by the CDC because the CDC claimed it requested data that was de-identified 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 de-identified 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,” ICAN stated.

A spokesperson for the CDC told The Epoch Times CDC does not comment on pending litigation. The Epoch Times has contacted The Department of Health and Human Services for comment.

ICAN stated that it believes that members of the public should “have immediate access to all v-safe data in de-identified form,” particularly in light of the fact that the Biden administration is mandating vaccines to millions of Americans.

“Despite the fact that this de-identified 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,” the nonprofit stated.

“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 [Department of Health and Human Services] demanding that a court compel them to release this data.”

ICAN was founded by Del Bigtree in 2016. In 2021, the organization filed a lawsuit against the CDC to request that the agency take down its statement claiming that vaccines don’t cause autism from its webpage on autism and vaccines.

Katabella Roberts is a reporter currently based in Turkey. She covers news and business for The Epoch Times, focusing primarily on the United States.