The Institute of Medicine (IOM) Reports and NVIC Statements
The National Academy of Sciences (NAS) was established in 1863 under President Abraham Lincoln's administration to report on science to policymakers and the public. In 1970 the Institute of Medicine (IOM) of NAS – renamed the Health and Medicine Division in March 2016 - was chartered as the health arm of the NAS to provide evidence to the government and private sector that would assist in informed health decisions.
In the National Childhood Vaccine Injury Act of 1986, and Congress directed DHHS to contract with the Institute of Medicine (IOM), to evaluate and report on adverse effects of federally recommended childhood vaccines. Beginning in 1990, IOM appointed committees of experts to review the evidence in the medical literature and from other sources on the safety of government recommended and mandated childhood vaccines.
NVIC’s co-founder and president Barbara Loe Fisher was invited to participate as a consumer representative on an Institute of Medicine Vaccine Safety Forum, which sponsored public vaccine safety workshops and published reports on vaccine adverse detection and response and vaccine safety research, and she was a co-editor of the Forum’s 1997 report on Risk Communication and Vaccination. Barbara was also invited to make presentations to IOM expert committees reviewing the evidence for vaccine risks in 2001 and 2012.
IOM Vaccine Safety Reports (1991-2013)
IOM published a series of reports on evidence for adverse effects of vaccines between 1991 and 2013 confirming that:
- Vaccines can and do carry risks for complications that can be greater for some individuals than others and may lead to chronic brain and immune system damage or death. IOM committees published reports in 1991, 1994a, 1994b, and 2012 and found that the following health problems are causally related to vaccination:
- Acute encephalopathy (brain inflammation)
- Chronic Nervous System Dysfunction (brain damage)
- Anaphylaxis (whole-body allergic reaction)
- Febrile Seizures (convulsions with fever)
- Guillain-Barre Syndrome (peripheral nerve inflammation)
- Brachial Neuritis (arm nerve inflammation)
- Deltoid Bursitis (shoulder inflammation)
- Acute & Chronic Arthritis (joint inflammation)
- Syncope (sudden loss of consciousness/fainting)
- Hypotonic/Hyporesponsive Episodes (shock and “unusual shock-like state)
- Protracted, Inconsolable Crying and Screaming
- Vaccine Strain Infection (smallpox, live polio, measles, varicella zoster vaccines)
- Death (smallpox, live polio, measles vaccines)
- IOM published a report in 2012 revealing that there were continuing significant gaps in scientific knowledge about the biological mechanisms of vaccine injury and death, a point that was made two decades earlier in 1991 and 1994 IOM reports. Because there are not enough methodologically sound epidemiological and biological mechanism studies evaluating vaccine adverse events, the IOM committee could not come to definitive conclusions about causation for many of the reported vaccine reactions involving chronic brain and immune system dysfunction and death. The Committee also concluded that some individuals are more susceptible to vaccine reactions for genetic, biological, environmental and other reasons that have not been fully identified.
- For eight routinely used vaccines, (MMR, DTaP, hepatitis B, hepatitis A, varicella zoster and meningococcal) there were too few scientifically sound studies published in the medical literature to determine whether more than 100 serious brain and immune system problems are or are not caused by the vaccines, including multiple sclerosis, arthritis, lupus, stroke, SIDS, autism and asthma.
- Both epidemiologic and biological mechanism research suggest that there are known and unknown biological, genetic and environmental high risk factors, which can increase “individual susceptibility” to vaccine reactions. These predispositions can include genetic variants (in human or microbiome DNA), environmental exposures, behaviors and illness or developmental stage, all of which can interact and, while some of the predispositions may be detectable before vaccination, others are not.
- IOM published a report in 2013 that revealed the federally recommended birth to six-year old child vaccine schedule had not been fully scientifically evaluated and there was not enough scientific evidence for physician committees to determine if the childhood vaccine schedule is or is not associated with the development of the following brain and immune system disorders prevalent among children today:
- Learning disorders
- Communication disorders
- Developmental disorders
- Intellectual disability
- Attention deficit disorder
- Disruptive behavior disorder
- Tics and Tourette’s syndrome
- Febrile seizures
Since 1982, NVIC has advocated that well-designed, independent, on-going scientific studies must be conducted to: (1) define the various biological mechanisms involved in vaccine injury and death: (2) identify genetic and other biological high risk factors for suffering chronic brain and immune system dysfunction after vaccination; and (3) evaluate short and long-term health outcomes of individuals, who use many vaccines, and those, who use fewer or no vaccines, to determine the health effects of vaccination on individuals and the public health.
Below are links to selected statements by NVIC to the IOM in the accomplishment of these vaccine safety and research advocacy goals.
- NVIC's Statement on Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies - Jan. 16, 2013
- NVIC's Statement on Conducting Research into Health Outcomes of Vaccinated and Unvaccinated Children - Feb. 9, 2012
- NVIC's Statement on the Institute of Medicine Report on Adverse Effects of Vaccines - Aug. 25, 2011
- IOM Committee on NIP's Procedures & Data Sharing Program - Aug. 23, 2004
- IOM Safety Review Committee: Vaccine Safety Research & Reports - Jan. 2001
- Institute of Medicine Immunization Safety Committee - Jan. 11, 2001
- IOM Vaccine Safety Forum Workshop on Risk Communication & Vaccination - May 13, 1996
- Statement on Vaccine Safety Research Needs - Perspective From Parents - April 1, 1996
- Vaccine Adverse Event Report Response Methodologies IOM Vaccine Safety Forum - Nov. 6, 1995
- Statement on Vaccine Adverse Event Detection Methodologies - Nov. 6, 1995
- IOM Vaccine Safety Forum Statement: Where we stand? - Nov. 6, 1995
- NVIC Statement Opposing Continued Use of Live Oral Polio Vaccine (OPV) - June 7, 1995
Institute of Medicine (IOM) Publications Related to Vaccine Safety
Adverse Effects of Vaccines: Evidence and Causality
Adverse Effects of Vaccines: Evidence and Causality published by the Institute of Medicine (2012). Reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. NVIC Note: This report investigated 158 of the most commonly reported vaccine adverse events and for 85%, or 135, of these events the IOM was prevented from determining causality due to either an absence of science, or the lack of quality science.
Multiple Immunizations and Immune Dysfunction
Multiple Immunizations and Immune Dysfunction published by the Institute of Medicine (2002). The committee recommends limited but continued public health attention to this issue in terms of capitalizing on current research efforts. No recommendations for policy review is made, but the committee does recommend an analysis of new frameworks for immunization policy, particularly as the number of licensed vaccines increases.
Vaccine Safety Forum: Summaries of Two Workshops
Vaccine Safety Forum: Summaries of Two Workshops published by the Institute of Medicine (1997). The Vaccine Safety Forum convened a workshop entitled Research to Identify Risks for Adverse Events Following Vaccination: Mechanisms and Possible Means of Prevention. The workshop discussed the various immunologic and genetic factors that might influence individuals' responses to vaccines, current research aimed at assessing what populations are at increased risk for experiencing adverse events from vaccines, and research avenues that could be pursued in this regard.