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Executive Summary - Immunization Safety Review - NCBI Bookshelf
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health. Institute of Medicine US Immunization Safety Review Committee; Stratton K, Almario D, McCormick MC, editors. Immunization Safety Review: Hepatitis B Vaccine and Demyelinating Neurological Disorders. Washington DC : National Academies Press US ; Immunization advisory bodies recommend that all infants, adolescents, and high-risk adults receive the hepatitis B vaccine for protection from serious liver disease, ncbi peer reviewed, including cirrhosis and hepatocellular carcinoma.
These recommendations have been viewed skeptically by some because of concerns about the safety of the vaccine and because of a perception that hepatitis B infection is not a serious risk to the general population.
The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that the hepatitis B vaccine causes demyelinating neurological disorders, such as multiple sclerosis and Guillain-Barré syndrome.
There is a theoretical basis for the hypothesis that vaccines, ncbi peer reviewed, including the hepatitis B vaccine, could cause demyelinating disorders. A review of the scant and indirect evidence that relevant biological mechanisms could operate in humans in response to the hepatitis B vaccine to produce disease provides weak support for this theory. However, the committee found that the ncbi peer reviewed evidence i.
The evidence was inadequate to accept or reject a causal relationship between the hepatitis B vaccine and all other demyelinating conditions. Demyelinating disorders are often quite devastating, as are the sequelae of chronic hepatitis B infection. The committee found evidence that some parents and health care workers are skeptical about the vaccine due more to a perception that the vaccine is unnecessary, rather than due to a large concern about the safety of the vaccine.
The committee is aware, however, that there are some people who very much object to the vaccine ncbi peer reviewed the basis of the perception that not all infants and children are at risk for hepatitis B infection and on the basis of concerns about the safety.
Because of ncbi peer reviewed lack of epidemiological data on conditions other than MS in adults, the committee recommends further attention in the form of research and communication.
However, the committee does not recommend that national and federal vaccine advisory bodies review the hepatitis B vaccine on the basis of concerns about demyelinating disorders. See Box ES-1 for a summary of all conclusions and recommendations. Committee Conclusions and Recommendations.
Immunization to protect infants and children from vaccine-preventable diseases is one ncbi peer reviewed the greatest achievements of public health. Immunization is not without risks, however. It is well established, for example, that the oral polio vaccine can on rare occasion cause paralytic polio.
The Immunization Safety Review Committee was established by the Institute of Medicine IOM to evaluate the available evidence on a series of immunization safety concerns. The committee is charged with examining three immunization safety hypotheses each year during the three-year study period — While all of the committee members share ncbi peer reviewed view that immunization is generally beneficial, none of them has a vested interest in the specific immunization safety issues that come before the group.
In this report, which is the fourth in the series, the committee examines the hypothesis that the hepatitis B vaccine increases the risk for demyelinating disorders of the central or peripheral nervous systems, including multiple sclerosis MS and Guillain-Barré syndrome GBS. The conclusions and recommendations of the committee's first three reports— Immunization Safety Review: Measles-Mumps-Rubella Vaccine and Autism IOM, ncbi peer reviewed, aImmunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders IOM, band Immunization Safety Review: Multiple Immunizations and Immune Dysfunction IOM, — ncbi peer reviewed summarized in Appendix A.
For each hypothesis to be examined, the committee assesses both the scientific evidence and the significance of the issue for society. The scientific assessment has ncbi peer reviewed components: an examination of the epidemiological and clinical evidence regarding a possible causal relationship between the immunization and the adverse event; and an examination of biological theory and experimental evidence from studies in humans, ncbi peer reviewed, animals, or in vitro systems regarding mechanisms that might be relevant to the hypothesis.
The significance assessment addresses such considerations as the burden of the health ncbi peer reviewed associated with the vaccine-preventable disease and with the adverse event in question, as well as the level of public concern about the safety issue, ncbi peer reviewed.
The Immunization Safety Review Committee has adopted the framework for assessing causality developed by its predecessors convened by the IOM in and under congressional mandate of P. The categories of causal conclusions used by the committee are as follows:. Assessments begin from a position of neutrality regarding the specific vaccine safety hypothesis under ncbi peer reviewed. That is, there is no ncbi peer reviewed that a specific vaccine or vaccine component does or does not cause the adverse event in question.
The committee does not conclude that the vaccine does not cause the adverse event merely if the evidence is inadequate to support causality.
Although no firm rules establish the amount of evidence or the quality of the evidence required to support a specific category of causality conclusion, ncbi peer reviewed, the committee uses standard epidemiological criteria to guide its decisions.
Evidence that is sparse, conflicting, of weak quality, or just suggestive either towards or ncbi peer reviewed from causality falls into this category. The sources of evidence considered by the committee in its scientific assessment of causality include epidemiological and clinical studies. Epidemiological studies carry the most weight in a causality assessment. Case reports and case series are generally inadequate by themselves to establish causality.
The committee's scientific assessment includes biological mechanisms, ncbi peer reviewed which it has established three general categories of evidence ncbi peer reviewed biological mechanisms:. Theory only: A reasonable mechanism can be hypothesized that is commensurate with scientific knowledge and that does not contradict known physical and biological principles, but it has not been demonstrated in whole or in part in humans or in model systems.
Postulated mechanisms by which a vaccine might cause a specific adverse event but for which no coherent theory exists would not meet the criteria for this category. Experimental evidence that the postulated mechanism operates in animals or humans: Experimental ncbi peer reviewed often describes effects on just one or a few of the steps in the pathological process required for expression of disease.
Showing that multiple components of the theoretical pathways operate in reasonable experimental models increases confidence that the mechanisms could possibly result in disease in humans. Evidence that a relevant immunization-related mechanism ncbi peer reviewed in known disease in humans: For example, a relevant wild-type infection causes the adverse health outcome, ncbi peer reviewed, or another vaccine has been demonstrated to cause the same adverse outcome by the same or a similar mechanism.
If the committee identifies evidence related to a biological mechanism that could be operational, it will offer a summary judgment of the ncbi peer reviewed of evidence as weak, moderate, or strong.
This summary reflects the quantity and the quality of the evidence. Quality includes factors such as the relevance of the evidence to the immunization safety hypothesis and the rigor of the experiment s. Published reports that have been subjected to a rigorous peer review process carry the most weight in the committee's assessment.
Immunization safety studies and other data reviewed by the committee are funded by a variety of sources—NIH, CDC, ncbi peer reviewed, vaccine manufacturers, research advocacy organizations, or foundations. The committee relies on editorial and peer review procedures to ensure the disclosure of potential conflicts of interest that might be related to the source of funding for the research study. In general, the committee cannot rely solely on unpublished data in making its scientific assessments regarding either causality or biological mechanisms because they have not undergone a formal review and must, therefore, be interpreted with caution.
In reviewing unpublished material, the committee applies generally accepted standards for assessing the quality of scientific evidence, as described above, ncbi peer reviewed. All unpublished data reviewed by the committee and cited in ncbi peer reviewed report are available—in the form reviewed by the committee—through the public access files of the National Academies.
Information about the public access files is available at —— or www. For this review the committee addressed the relationship between hepatitis B vaccine and the following neurological diseases: the central nervous system CNS demyelinating diseases of MS onset ncbi peer reviewed relapseoptic neuritis, acute disseminated encephalomyelitis ADEMand transverse myelitis; and the peripheral nervous system PNS demyelinating diseases of GBS and brachial neuritis.
The committee chose to focus on these specific conditions because they are serious neurological disorders and known clinical entities. Published epidemiological studies and case reports investigating their association with hepatitis B vaccine are available, and a substantial body of literature ncbi peer reviewed on the pathophysiology of several of these conditions e. MS is the most common chronic inflammatory demyelinating disease of the CNS in humans.
In the United States, approximatelyindividuals, about 0. Women are affected approximately twice as often as men. The incidence of the disease is highest in persons between the ages of 20 and 40 years, but it is also diagnosed in children as young ncbi peer reviewed 2 years, ncbi peer reviewed, and in older individuals. Common presenting symptoms include focal sensory deficits, focal weakness, a loss of ncbi peer reviewed, double vision, ncbi peer reviewed, imbalance, and fatigue.
The severity of the disease can range from subclinical forms that are diagnosed only after death from other causes to hyperacute forms that lead to death within the first few months after disease onset.
The cause of MS remains elusive, ncbi peer reviewed, but susceptibility appears to involve both genetic and environmental factors.
Genetic factors are reflected in an increased risk of developing MS among family members of MS patients. The concordance rate among dizygotic fraternal twins and other siblings is 2—5 percent and 30—35 percent in monozygotic identical twins Waubant and Stuve, Optic neuritis is caused by an inflammation of the optic nerve, with lesions occurring behind the orbit but anterior to the optic chiasm IOM, Symptoms include rapid vision loss, pain associated with eye movement, dimmed vision, abnormal color vision, altered depth perception, and Uhthoff s phenomenon—in which visual ncbi peer reviewed is associated with an increase in body temperature IOM, c.
The ncbi peer reviewed of cases resolve within a few weeks to months of onset. Optic neuritis can occur ncbi peer reviewed an isolated monophasic disease, or it may be a symptom of other demyelinating diseases such as ADEM or MS. ADEM, an inflammatory demyelinating disease of the CNS that can result in permanent and severe neurological disability, occurs most commonly in children and adolescents.
In contrast to MS, which involves recurring or progressive neurological consequences of demyelination, ADEM is normally defined as a monophasic disorder that is, relapses do not occur that results from a discrete episode of inflammatory demyelination. ADEM most often occurs following an infection, and it is associated with several viral pathogens, ncbi peer reviewed, including the measles, rubella, and varicella zoster viruses.
Transverse myelitis, which also usually occurs after viral or bacterial may represent a variant of ADEM restricted to the spinal cord. Symptoms may begin as pain, weakness, or tingling, but then progress within weeks to paralysis, urinary retention, or loss of bowel control.
GBS is the most common acquired peripheral demyelinating disease in humans. Its incidence is estimated at 1 to 2 cases perpopulation per year both in children and adults IOM, GBS typically occurs several days or weeks after an infectious event, commonly a diarrheal illness or a viral upper respiratory infection, ncbi peer reviewed. From 10 to 30 percent of all cases are associated with Campylobacter jejuni infections.
An increased risk for GBS has also been linked to exposure to certain vaccines, most notably the influenza vaccine the swine flu vaccine. The characteristic clinical feature of GBS is an acute, rapidly progressive, ascending, and symmetric weakness, with loss of deep tendon reflexes and possible tingling in the feet and hands, and muscle aches myalgia. Facial, oculomotor, oropharyngeal, and respiratory muscles may also be involved, and some patients may require respiratory support.
Most patients will improve and return to normal functioning within 6 to 9 months, but some patients experience relapses or a prolonged disease course with residual neurological deficits.
Brachial neuritis is characterized by a deep, severe pain in the shoulder and upper arm. The pain generally subsides within days or weeks, but weakness and muscle atrophy in the affected arm are common side-effects.
The hepatitis B virus HBV can produce an acute or chronic 1 infection causing inflammation of the liver. Symptoms of acute HBV infection include jaundice, fatigue, ncbi peer reviewed, joint pain, abdominal pain, loss of appetite, nausea, and diarrhea.
About 30 percent of adult infections are asymptomatic Coleman et al. Among infants infected at birth, the risk of chronic infection is 90 percent; among persons infected as adults, about 6 percent develop chronic infections CDC, a. Chronic carriers of HBV are at increased risk for cirrhosis and hepatocellular carcinoma HCCand 15—25 percent of them die from liver disease Lee, Rates ncbi peer reviewed hepatitis B infection vary widely throughout the world.
The highest prevalence is found in some regions of Southeast Asia, China, ncbi peer reviewed, and Africa; in these regions over half of the population will contract acute hepatitis B. HBV is transmitted through bodily fluids, with the highest viral concentrations found in blood, serum, and wound ncbi peer reviewed Halsey, HBV can remain viable outside the body for more than 7 days Mast, and its relative infectivity is times greater than that of HIV Hilleman, Transmission occurs through sexual contact, intravenous drug use and needle sharing, occupational exposure to bodily fluids of infected persons, ncbi peer reviewed, and contact with an infected family member or contaminated articles in the household.
Newborns can be infected by transmission of the virus from an infected mother also called perinatal transmission. A vaccine against HBV first became available in the United States in
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Diagnosis and Management of Rheumatoid Arthritis: A Review JAMA. Oct 2;(13) doi: /jama Authors Daniel Aletaha 1, Josef S Smolen 1 Affiliation 1 Division of Rheumatology, Department of Medicine NLM Catalog: Journals referenced in the NCBI Databases Limit your NLM Catalog search to the subset of journals that are referenced in NCBI database records Enter topic, journal title or abbreviation, or ISSN: Advanced Search All unpublished data reviewed by the committee and cited in this report are available—in the form reviewed by the committee—through the public access files of the National Academies. Information about the public access files is available at –– or blogger.com
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