The Food and Drug Administration (FDA) is the US federal agency responsible for licensing vaccines. Pharma companies conduct clinical trials and submit data to the FDA, which then grants (or denies) licensure. The FDA is not the entity that conducts vaccine clinical trials; it reviews and accepts data from trial sponsors (pharma companies).
Role in Vaccine Policy
Licensure: FDA grants licensure for vaccines based on pharma-submitted clinical trial data.
VRBPAC: FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) advises on vaccine licensure decisions. Per Aaron Siri, the "overwhelming majority" of VRBPAC members have had substantial pharma ties (per the 2000 Congressional Report on FDA-CDC Conflicts).
Package inserts: FDA-mandated documentation (package inserts) includes the clinical trial data relied upon for licensure, including safety monitoring duration. This is how the 5-day Recombivax HB and 4-day Engerix-B windows were documented.
Key Findings from This KB
Recombivax HB was licensed based on a trial monitored for 5 days in 147 infants, with no control group — all per FDA package insert Section 6.1.
ICAN FOIA confirmed FDA held no Recombivax HB safety data beyond 5 days.
ICAN sued FDA over Engerix-B; FDA never produced safety data beyond a few days despite years of litigation.
Conflicts of Interest
The 2000 Congressional Report on FDA-CDC Conflicts found the "overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry" on FDA's VRBPAC.
Regulatory Failures
Acceptance of Pharma Self-Reporting on Safety
In clinical trials, the FDA permits pharma companies to determine which adverse events are "related to the vaccine" using their own paid investigators. Examples:
Maddie de Garay (Maddie de Garay): Pfizer initially reported her wheelchair + feeding tube injury as "functional abdominal pain." Only after an outside email from Steve Kirsch prompted FDA to request more information did Pfizer disclose more injuries — but its paid principal investigator concluded he did not "feel" the injuries were vaccine-related. The FDA accepted this self-serving conclusion, ignored letters from Siri's firm, and took no further action.
ActHIB (Sanofi): 3.4% SAE rate within 30 days — "None was assessed by the investigators as related to the study vaccines" — the FDA accepted this.
Asymmetric Evidence Standards
For efficacy claims, the FDA required a statistical comparison (vaccinated group vs. placebo/control). For safety (deaths and serious injuries), the FDA permitted Pfizer and other pharma companies to explain each case away individually using their own investigators' judgment. Siri argues this asymmetry is built into the review process.
VAERS EB Data Mining Hidden from ICAN
The FDA was assigned to conduct Empirical Bayesian (EB) data mining of VAERS data for Covid-19 vaccine safety signals. After ICAN obtained CDC's hidden PRR data (showing massive safety signals), ICAN submitted a FOIA for the FDA's EB data mining results. The FDA:
Denied the FOIA
Filed a motion to stay the resulting federal lawsuit for at least 18 months, citing "resource constraints"
The lawsuit has been ongoing for over 2.5 years with no resolution
How does the FDA approve vaccines and who funds the review process?
Pharmaceutical companies fund and conduct clinical trials, then submit data to the FDA for review. The FDA does not conduct vaccine trials itself. The 2000 Congressional investigation found "the overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry" on FDA's vaccine advisory committee VRBPAC. Industry user fees under PDUFA fund a significant portion of the FDA's drug and biologics review budget.
Does the FDA accept pharma companies' own safety assessments at face value?
Yes. In clinical trials, the FDA permits pharma companies to determine which adverse events are "related to the vaccine" using their own paid investigators. When 3.4% of babies in the ActHIB trial had serious adverse events, Sanofi's investigators assessed none as related — the FDA accepted this. When Pfizer reported Maddie de Garay's wheelchair and feeding tube injuries as "functional abdominal pain," the FDA accepted the principal investigator's conclusion that injuries were not vaccine-related.
Why does the FDA apply asymmetric evidence standards for vaccine efficacy vs. safety?
For efficacy claims, the FDA required statistical comparisons (e.g., Pfizer's 8 vs. 162 symptomatic COVID cases showing 95% efficacy). For safety — specifically 21 deaths in the vaccinated group vs. 17 in the placebo group — the FDA permitted Pfizer to explain each death individually using their investigators' judgment rather than requiring a statistical comparison. The same asymmetry appears across other vaccine approvals.
What happened when ICAN requested the FDA's VAERS safety signal data?
The FDA was assigned to conduct Empirical Bayesian data mining of VAERS data for COVID-19 vaccine safety signals. After ICAN obtained CDC's hidden PRR data showing massive safety signals, ICAN submitted a FOIA for the FDA's EB results. The FDA denied the FOIA and filed a motion to stay the resulting lawsuit for at least 18 months, citing resource constraints. The litigation has been ongoing for over 2.5 years with no resolution.
What did the 2000 Congressional report find about FDA's vaccine committee?
The House Committee on Government Reform found that "the overwhelming majority of members, both voting members and consultants, have substantial ties to the pharmaceutical industry" on FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). The report found "loose standards" where "significant conflicts of interest are not deemed to be conflicts." These are the advisors whose recommendations determine which vaccines are licensed for American children.
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