ICAN's FOIA requests and vaccine safety legal actions — led by attorney Aaron Siri — have produced landmark court stipulations, forced the release of v-safe data, and revealed that HHS never filed a single required biennial vaccine safety report.
The Informed Consent Action Network (ICAN) is the nonprofit organization founded by Aaron Siri that has funded a series of FOIA requests, lawsuits, and other legal actions targeting gaps in vaccine safety data held by the FDA, CDC, and HHS.
Overview
ICAN was established to pursue legal and advocacy strategies around informed consent in vaccine policy. It operates as the financial and organizational vehicle for Siri's vaccine-related litigation and FOIA campaigns. Its mission, as reflected in its actions, is to compel government agencies to produce (or acknowledge the absence of) safety data underlying vaccine licensure and recommendations.
Role in Vaccine Policy
Key ICAN actions documented in this KB:
Recombivax HB FOIA: Filed FOIA request with FDA for clinical trial reports relied upon to license Recombivax HB; confirmed only 5-day safety monitoring window. Documents published publicly.
Engerix-B lawsuit: Sued FDA demanding clinical trial reports reviewing safety for more than one week after Engerix-B injection; FDA never produced a single such document after years of pressing.
HHS safety data request: Formally requested HHS provide post-licensure Hep B safety data; HHS pointed to seven studies, none of which supported safety in babies.
CDC autism lawsuit: Sued CDC for studies showing infant vaccines (first 6 months of CDC schedule) don't cause autism; CDC could not produce a single qualifying study.
What has ICAN accomplished through its FOIA requests and lawsuits?
ICAN's FOIA litigation has confirmed that Recombivax HB's safety was monitored for only 5 days in 147 children. It proved HHS never filed a single biennial vaccine safety report required by the 1986 Act. It forced the release of V-safe data showing 7.7% of COVID vaccine recipients needed medical care. It obtained CDC's hidden PRR data showing massive safety signals. And it sued CDC for autism studies, resulting in a court stipulation revealing no qualifying studies existed.
What did ICAN's lawsuit reveal about HHS vaccine safety reports?
ICAN requested all biennial vaccine safety reports from HHS via FOIA in 2017. HHS admitted it had never produced or submitted a single report to Congress in the 30 years since the 1986 Act took effect. When ICAN requested again in 2021, HHS confirmed in 2023 that still no reports had ever been filed. The Task Force on Safer Childhood Vaccines made recommendations only once (April 1996) and was disbanded in 1998.
How did ICAN force the release of the V-safe data?
ICAN filed two federal lawsuits against the CDC to obtain full V-safe health impact data. The CDC resisted disclosure for over two years. When the data was finally released, it showed 7.7% of V-safe users needed medical care after COVID vaccination, 25% missed work or couldn't perform normal activities, and approximately 75% of medical visits were urgent care, ER, or hospitalization. The CDC had published 40+ studies using V-safe data but reported only the first week of health impact results.
What did ICAN's CDC autism lawsuit prove?
ICAN sued CDC in federal court for all studies the CDC relied on to claim infant vaccines don't cause autism. CDC filed a court stipulation listing 20 studies as its entire evidence base. Fifteen were exclusively about MMR or thimerosal — not the infant vaccines given in the first 6 months. Not a single study showed that DTaP, Hep B, Hib, PCV, or IPV do not cause autism.
Who leads ICAN's legal work?
Attorney Aaron Siri, founder of ICAN and managing partner of Siri & Glimstad LLP, leads the organization's legal work. He conducted the landmark 9-hour deposition of Stanley Plotkin in 2018 and has led FOIA campaigns against the FDA, CDC, and HHS. ICAN is the nonprofit that funds these legal actions and advocacy strategies around informed consent in vaccine policy.
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