Summary Hepatitis B virus (HBV) is transmitted via blood or sexual contact. Persons with chronic HBV infection are at increased risk for cirrhosis and liver cancer and require medical care. This report updates and summarizes previously published recommendations from the Advisory Committee on Immunization Practices (ACIP) and CDC regarding the prevention of HBV infection in the United States. ACIP recommends testing all pregnant women for hepatitis B surface antigen (HBsAg), and testing HBsAg-positive pregnant women for hepatitis B virus deoxyribonucleic acid (HBV DNA); administration of HepB vaccine and hepatitis B immune globulin (HBIG) for infants born to HBV-infected women within 12 hours of birth, followed by completion of the vaccine series and postvaccination serologic testing; universal hepatitis B vaccination within 24 hours of birth, followed by completion of the vaccine series; and vaccination of children and adolescents aged <19 years who have not been vaccinated previously. ACIP recommends vaccination of adults at risk for HBV infection, including universal vaccination of adults in settings in which a high proportion have risk factors for HBV infection and vaccination of adults requesting protection from HBV without acknowledgment of a specific risk factor. These recommendations also provide CDC guidance for postexposure prophylaxis following occupational and other exposures. This report also briefly summarizes previously published American Association for the Study of Liver Diseasest guidelines for maternal antiviral therapy to reduce perinatal HBV transmission
There was no increase in the risk of vaccine-associated Guillain-Barré syndrome from 1992-1993 to 1993-1994. For the two seasons combined, the adjusted relative risk of 1.7 suggests slightly more than one additional case of Guillain-Barré syndrome per million persons vaccinated against influenza.
Guillain-Barré syndrome (GBS) is the leading cause of acute flaccid paralysis in developed countries and is characterized by various degrees of weakness, sensory abnormalities and autonomic dysfunction. Although the underlying aetiology and pathophysiology of GBS are not completely understood, it is broadly believed that immune stimulation plays a role in its pathogenesis. Thus, since vaccines have an effect on the immune system it is biologically plausible that immunizations may be associated with subsequent GBS. The objective of this article is to review the current body of evidence that either supports or does not support a causal, rather than just temporal, association between various vaccines and GBS, and to provide an evidence-based review of this issue. The scope of the article includes published reports that, regardless of method of case ascertainment, appeared in peer-reviewed literature between 1950 and 2008. Our review indicates that, with rare exceptions, associations between vaccines and GBS have been only temporal. There is little evidence to support a causal association with most vaccines. The evidence for a causal association is strongest for the swine influenza vaccine that was used in 1976-77. Studies of influenza vaccines used in subsequent years, however, have found small or no increased risk of GBS. Older formulations of rabies vaccine cultured in mammalian brain tissues have been found to have an increased risk of GBS, but newer formulations of rabies vaccine, derived from chick embryo cells, do not appear to be associated with GBS at a greater than expected rate. In an earlier review, the Institute of Medicine concluded that the evidence favoured a causal association between oral polio vaccine and tetanus toxoid-containing vaccines and GBS. However, recent evidence from large epidemiological studies and mass immunization campaigns in different countries found no correlation between oral polio vaccine or tetanus toxoid-containing vaccines and GBS. Spontaneous reports to the US Vaccine Adverse Events Reporting System shortly after the introduction of quadrivalent conjugated meningococcal vaccine (MCV4) raised concerns of a possible association with GBS. Comparisons with expected rates of GBS, however, were inconclusive for an increased risk, and lack of controlled epidemiological studies makes it difficult to draw conclusions about a causal association. For other vaccines, available data are based on isolated case reports or very small clusters temporally related to immunizations, and no conclusion about causality can be drawn. There are certain circumstances in which immunizing individuals, particularly those with a prior history of GBS, may require caution. However, the benefit of vaccines in preventing disease and decreasing morbidity and mortality, particularly for influenza, needs to be weighed against the potential risk of GBS.
Summary Hepatitis A is a vaccine-preventable, communicable disease of the liver caused by the hepatitis A virus (HAV). The infection is transmitted via the fecal-oral route, usually from direct person-to-person contact or consumption of contaminated food or water. Hepatitis A is an acute, self-limited disease that does not result in chronic infection. HAV antibodies (immunoglobulin G [IgG] anti-HAV) produced in response to HAV infection persist for life and protect against reinfection; IgG anti-HAV produced after vaccination confer long-term immunity. This report supplants and summarizes previously published recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the prevention of HAV infection in the United States. ACIP recommends routine vaccination of children aged 12–23 months and catch-up vaccination for children and adolescents aged 2–18 years who have not previously received hepatitis A (HepA) vaccine at any age. ACIP recommends HepA vaccination for adults at risk for HAV infection or severe disease from HAV infection and for adults requesting protection against HAV without acknowledgment of a risk factor. These recommendations also provide guidance for vaccination before travel, for postexposure prophylaxis, in settings providing services to adults, and during outbreaks
a b s t r a c tIn preparation for pandemic vaccine safety monitoring, we assessed adverse events reported to the Vaccine Adverse Event Reporting System following receipt of trivalent inactivated influenza vaccines among adults from 1990 through 2005. We calculated reporting rates for nonserious, serious, and neurological adverse events. We reviewed reports of recurrent events and deaths, as well as reports identified through advanced signal detection. The most frequently reported events were local reactions and systemic symptoms. Guillain-Barré syndrome was the most frequently reported serious event (0.70 reports per million vaccinations). Adverse event reporting rates have been reasonably constant over time. No new safety concerns emerged after our review of 15 years of post-licensure surveillance data. These findings provide useful information if pandemic vaccine is rapidly distributed and pre-licensure data are limited.Published by Elsevier Ltd. BackgroundInfluenza vaccines are the primary method for the control of influenza and its complications and the most widely used type of vaccine for adults in the United States (US). The US and much of the world is preparing for the use of pandemic influenza vaccines [1]. However, even with extensive planning, limited safety data will be available for these vaccines prior to use. Safety profile highlights of the seasonal trivalent inactivated influenza vaccines (TIV) can provide a background for interpretation of adverse events that can be anticipated if pandemic influenza vaccines must be employed in the future. In addition, special importance for TIV safety monitoring stems from the 1976-1977 influenza season, when a mass vaccination effort in the US against swine influenza was halted after the vaccines appeared to be associated with an elevated risk of Guillain-Barré syndrome (GBS) [2].Placebo-controlled trials among older and healthy young adults have demonstrated that TIV administration is not associated with an increased risk of systemic symptoms (e.g., fever, malaise, myalgia); the most frequent adverse effect following vaccination is pain at the injection site [3] including anaphylaxis can occur [3], but the latter is rare [4]. A pre-licensure study of the recently licensed H5N1 vaccine identified headache, malaise, and myalgia as the most frequent systemic symptoms but also identified these at similar rates among placebo recipients [5]. Clinical trials are generally not large enough to detect rare adverse events. Post-licensure safety data provide examples of adverse event experiences among a larger and more diverse population, and reporting of adverse events following receipt of seasonal TIV to the US Vaccine Adverse Event Reporting System (VAERS) is an important source of this information. We examined 15 years of VAERS data among adults aged ≥18 years to describe patterns of adverse events after seasonal vaccines and to identify possible safety concerns that might merit intensified monitoring or evaluation. Although pandemic influenza vaccines will differ fr...
Widespread use of varicella vaccine in the United States could enable detection of rare adverse events not identified previously. We reviewed data from 1995 to 2005 from the Vaccine Adverse Event Reporting System, including data from laboratory analyses, to distinguish adverse events associated with wild-type varicella-zoster virus (VZV) versus those associated with vaccine strain. Almost 48 million doses of varicella vaccine were distributed between 1995 and 2005. There were 25,306 adverse events reported (52.7/100,000 doses distributed); 5.0% were classified as serious (2.6/100,000 doses distributed). Adverse events associated with evidence of vaccine-strain VZV included meningitis in patients with concurrent herpes zoster. Patients with genetic predispositions may rarely have disease triggered by receipt of varicella vaccine. Overall, serious adverse events reported after varicella vaccination continue to be rare and must be considered relative to the substantial benefits of varicella vaccination. Ongoing safety surveillance and further studies may shed light on some of the hypothesized associations.
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