IOM vaccine adverse effects report: what the Institute of Medicine found — and couldn't find — about vaccine safety across its landmark reviews of the scientific evidence.
A 2012 report by the Institute of Medicine (IOM), now known as the National Academy of Medicine, commissioned and paid for by the CDC and HRSA (Health Resources and Services Administration) to review the entire body of vaccine safety literature for 158 commonly claimed vaccine harms. The report's findings are a central reference in Aaron Siri's critique of vaccine safety oversight.
Background
Commissioned by: CDC and HRSA
Date: 2012
IOM's mandate: The Institute of Medicine was established pursuant to a Congressional charter with the "explicit purpose… to provide advice that the government could trust to be free of partisan political influence." Described by legacy media as "the nation's most esteemed and authoritative advisors on issues of health and medicine."
What was reviewed: 158 harms that HRSA identified as the most commonly claimed vaccine injuries
Note: HRSA administers the National Vaccine Injury Compensation Program and directly defends against claims of vaccine injury — creating an institutional incentive for IOM to find vaccines safe.
Findings
Category
Number
Evidence supports causation (vaccines CAN cause this harm)
18
Evidence rejects causation (vaccines likely do NOT cause this harm)
5
Insufficient evidence to determine causation
135
For 135 of the 158 most commonly claimed serious vaccine injuries, the studies had not been conducted to determine whether or not vaccines cause them.
How Plotkin Interpreted the Results
Despite the IOM finding "insufficient evidence" for 135 harms, Stanley Plotkin testified during the Plotkin Deposition 2018 that vaccines do not cause those harms:
Encephalitis example: IOM: "inadequate evidence to accept or reject a causal relationship between hepatitis B vaccine and encephalitis." Plotkin: "No, I would say definitely not."
General pattern: When confronted with IOM's "insufficient evidence" conclusion, Plotkin argued: "In the absence of data, my conclusion is that there are no, there's no proof that causation exists."
When pressed, he admitted: "That's different than saying it doesn't cause it." But maintained his position.
Autism Finding
IOM found no studies ruling out a connection between DTaP/Tdap and autism
IOM found one study suggesting pertussis vaccines were associated with increased autism rates (which IOM discounted)
Congress ordered HHS to study the autism/pertussis connection in 1986; by 2012 no such study had been conducted
ICAN later sued CDC for studies showing infant vaccines (first 6 months) don't cause autism; CDC produced nothing
Significance
The IOM report is significant in two ways:
1. What it found: 135 of the most commonly claimed vaccine harms have never been adequately studied — a finding that Siri argues should have prompted urgent research but instead has been treated as a reason to declare vaccines safe.
2. How it was used: Plotkin and other vaccinologists cite the absence of this research as proof that vaccines are safe — inverting the scientific method.
What did the Institute of Medicine conclude about vaccine adverse effects?
The IOM reviewed 158 commonly claimed vaccine injuries in its 2012 report. It found evidence supporting causation for 18 harms, evidence rejecting causation for just 5 harms, and insufficient evidence to determine causation for 135 harms. For the vast majority of claimed serious vaccine injuries, the studies simply had not been conducted to determine whether vaccines cause them.
Did the IOM find studies ruling out a connection between DTaP and autism?
No. The IOM found no studies ruling out a connection between DTaP/Tdap and autism. It found one study suggesting pertussis vaccines were associated with increased autism rates, which IOM discounted. Congress had ordered HHS to study this connection in 1986, but by 2012 no such study had been conducted. ICAN later sued CDC for qualifying studies and CDC could not produce a single one.
How did Stanley Plotkin interpret the IOM's "insufficient evidence" findings?
Despite the IOM finding insufficient evidence for 135 vaccine harms, Plotkin testified during his 2018 deposition that vaccines do not cause those harms. When the IOM concluded evidence was "inadequate to accept or reject" a link between hepatitis B vaccine and encephalitis, Plotkin said "definitely not." He admitted his position was based on presumption rather than data, stating "in the absence of data, my conclusion is that there's no proof that causation exists."
Who commissioned and paid for the IOM vaccine safety report?
The CDC and HRSA (Health Resources and Services Administration) commissioned and paid for the IOM report. HRSA administers the National Vaccine Injury Compensation Program and directly defends against claims of vaccine injury — creating an institutional incentive favoring findings of safety. The IOM was established pursuant to a Congressional charter to provide advice "free of partisan political influence."
What did the IOM recommend after finding 135 harms were insufficiently studied?
The IOM recommended that the CDC commission prospective cohort studies comparing health outcomes in vaccinated vs. unvaccinated children. The CDC never conducted these recommended studies. Instead, the absence of research has been cited by vaccinologists as evidence that vaccines do not cause the 135 under-studied harms — substituting presumption for evidence.
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