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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:

  1. 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)
  1. 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.
  1. 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:
    • Asthma
    • Atopy
    • Allergy
    • Autoimmunity
    • Autism
    • Learning disorders
    • Communication disorders
    • Developmental disorders
    • Intellectual disability
    • Attention deficit disorder
    • Disruptive behavior disorder
    • Tics and Tourette’s syndrome
    • Seizures
    • Febrile seizures
    • Epilepsy

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.

Institute of Medicine (IOM) Publications Related to Vaccine Safety

Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies

Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies

Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies Released: January 16, 2013 - Pre-Publication Status. A new report from the Institute of Medicine, examines evidence about the schedule's safety and recommends the best way to conduct any needed investigations. Click here to read NVIC's summary of this report's vaccine safety science gaps.

Adverse Effects of Vaccines: Evidence and Causality

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.

Vaccine Safety Research, Data Access, and Public Trust

Vaccine Safety Research, Data Access, and Public Trust

Vaccine Safety Research, Data Access, and Public Trust published by the Institute of Medicine (2005). In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

Multiple Immunizations and Immune Dysfunction

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.

Risk Communication and Vaccination: Workshop Summary

Risk Communication and Vaccination: Workshop Summary

Risk Communication and Vaccination: Workshop Summary published by the Institute of Medicine (1997). The forum convened a workshop on risk communication and vaccination. Workshop speakers and participants discussed key concepts in risk communication, unique aspects of communicating risks about vaccines, and current practices in vaccine risk communication.

Vaccine Safety Forum: Summaries of Two Workshops

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.

DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis

DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis

DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis published by the Institute of Medicine in 1994. The committee concluded that the evidence is consistent with a causal relation between vaccination with DPT and acute encephalopathy (IOM, 1991), and the excess risk was estimated to range from 0 to 10.5 per million DPT immunizations.

Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality

Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality

Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality published by the Institute of Medicine (1994) for the U.S. Congress under the National Childhood Vaccine Injury Act of 1986. A review of the medical literature that documents evidence for and against a causal relationship between tetanus, diphtheria, polio, measles, mumps, rubella, HIB and hepatitis B vaccines and brain and immune system dysfunction.

Adverse Effects of Pertussis and Rubella Vaccines

Adverse Effects of Pertussis and Rubella Vaccines

Adverse Effects of Pertussis and Rubella Vaccines published by the Institute of Medicine (1991) for the U.S. Congress under the National Childhood Vaccine Injury Act of 1986A review of the medical literature that documents evidence for and against a causal relationship between pertussis and rubella vaccines and brain and immune system dysfunction.

 

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