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Use of a new combined vaccine in pediatric practices.

OBJECTIVE: On December 13, 2002, Pediarix, a combination vaccine that contains diphtheria, tetanus, acellular pertussis; hepatitis B; and inactivated polio vaccines, was licensed by the Food and Drug Administration for use in the primary immunization series. Use of this vaccine decreases the number of injections that children receive when completing their primary immunization series at the 2-, 4-, and 6-month well-child visits. The objective of this study was to determine the factors that influence the use of this combined vaccine in private pediatric practices, with particular attention to the perceived economic impact of Pediarix and actions taken to address this impact within the private pediatric setting. METHODS: A mail survey study was conducted of a random sample of 565 practicing pediatricians that was obtained from the American Medical Association Masterfile. Frequency distributions were developed for all responses, and the vaccine financing policies of the state of practice for each respondent were determined. Chi2 analysis was performed to assess any associations of the predictor variables with the outcome variables of interest, use or consideration of use of the Pediarix vaccine. Logistic regression was used to determine the independent association of the predictor variables with use or consideration of use of Pediarix. Regression models that did and did not include practice ownership as a predictor variable were developed. RESULTS: Response rate was 63% (N = 355). A total of 39% (n = 123) of the respondents' practices were purchasing Pediarix for use with their private patients. An additional 18% (n = 55) were considering purchasing the vaccine. Those who were in practices that were owned by hospitals or health systems were more likely than those who were in solo or group practices to purchase Pediarix for their private patients. Approximately half of the remaining respondents order Pediarix through their state immunization program. Among the 52% of respondents who did not, 23% reported that the vaccine was not yet available through their state program, and 47% stated that they did not want to use different vaccines for their public and private patients. Only 11% believed that Pediarix was not compatible with their other vaccine products. Physicians that currently were purchasing or considering purchasing Pediarix were more likely to be influenced by both parental and provider desire to decrease the number of injections at a single visit and the reduced time for immunization delivery. Fewer than 1% of respondents reported either having experienced or expecting to experience a significant decrease in practice revenue as a result of the use of Pediarix. CONCLUSIONS: Although use of the vaccine results in fewer administration fees for most physicians, the magnitude of the change seemed not to be significant for the majority of respondents or was outweighed by other factors. It also is possible that larger practices or buying cooperatives were able to negotiate discounted rates for Pediarix relative to the constituent products. This may have been a strategy of manufacturers and/or distributors to provide incentive for practices to switch to the combination product. Of note was the appreciation of respondents for the preferences of patients for fewer vaccines and, to a lesser degree, for the decrease in office staff time required to provide vaccination with multiple antigens when using Pediarix. Also, the role of the availability of a given vaccine through the Vaccines for Children program is important in its adoption into practice.

Adult↗

Polyarteritis nodosa and extrahepatic manifestations of HBV infection: the case against autoimmune intervention in pathogenesis.

Numerous extrahepatic manifestations have been reported in patients with both acute and chronic hepatitis B (arthralgias or arthritis, skin rashes, glomerulonephritis and neuritis), all of which are present in polyarteritis nodosa (PAN) which is the most unique and spectacular extrahepatic manifestation. In the 1970s, the frequency of PAN due to the hepatitis B (HBV) reached 30%. Immunization programs explain the decrease and it is now down to 7%. PAN usually occurs within 6 months of infection. Clinical manifestations reflect this most classic form of PAN, Hepatic manifestations including, ALT/AST elevations are mild and usually overlooked. Besides HBV, other viruses may be responsible for cases of vasculitides including PAN, HIV, Parvovirus B19, and EBV. Different pathogenic mechanisms have been identified but immune complexes are mainly thought to be responsible. In glomerulonephritis, detailed immunostaining and ultrastructural findings indicate that HBe antigen (Ag) is more likely to be the responsible antigen. In PAN, fewer reports are available and early studies with poorly defined antibodies need to be revisited. Interestingly almost all cases of HBV/PAN are associated with wild-type HBV infection, characterised by HBe antigenemia and high HBV replication, supporting the concept that lesions could result from the deposit of viral Ag/Ab complexes soluble in Ag excess, possibly involving HBe Ag. The recent observation of PAN cases associated with precore mutation which abrogates the formation of HBe Ag challenges this view. It may suggest that other, still undefined, circulating HBV-related Ag(s) distinct from HBe Ag could be involved. Remarkably, none of the HBV/PAN cases or glomerulonephritis exhibit antineutrophil cycoplasmic antibodies (ANCA) reactivity. Viral PAN can now be completely separated from other form of vasculitis mostly autoimmune in nature. Based on the efficacy of antiviral agents in chronic hepatitis B and of plasma exchanges in PAN we combined both therapies to treat HBV PAN. This was associated with swift recovery, even in the most severe forms. The perfect time correlation between inhibition of virus replication and resolution of all bioclinical signs suggest a direct pathogenic role of the virus possibly via immune complexes. Traditional immunosuppressive and steroid therapy should no longer be used for HBV PAN cases.

Autoimmunity↗

Prevalence of measles antibodies in hospital personnel.

A community outbreak of measles prompted a serologic survey of personnel in a hospital serving that community. Two hundred sixty-six personnel, primarily physicians (129) and nurses (100), voluntarily participated. Serum specimens were initially tested by the immunofluorescent antibody and enzyme-linked immunosorbent assay (EIA) methods. Specimens with negative results by either test were further examined using the hemagglutination inhibition and plaque neutralization (PN) methods. If EIA and PN results were negative, an individual was considered susceptible. Only one of the 98 participants born during or after 1957 and none of the 168 participants born before 1957 were serosusceptible. The low rate of serosusceptibility, in contrast to previous studies of young adults, appears attributable to the sensitivity of the testing methods used. Based on our experience, institutions considering a measles serologic testing and immunization program should expect to identify very few serosusceptible personnel, even among those born during or after 1957.

Adult↗

The National Survey of Children's Health: a new data resource.

CONTEXT: Federal and state maternal and child health programs are responsible for promoting and improving the health and well-being of children. To support achievement of this goal, the federal Maternal and Child Health Bureau (MCHB) in partnership with the National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention has developed a new survey that will provide uniform national and state data on the health and well-being of children, as well as the characteristics of their families and neighborhoods. PURPOSE: The National Survey of Children's Health was designed to produce reliable and representative state- and national-level estimates for Healthy People 2010 national prevention objectives, for each state's Title V needs assessment, and for Title V program planning and evaluation. In addition, it will provide a new data resource for researchers, advocacy groups, and other interested parties. It is anticipated that this survey will be repeated periodically, making trend analysis possible. METHODS: This survey was conducted using the State and Local Area Integrated Telephone Survey (SLAITS) mechanism, which shares the random-digit-dial sampling frame of the National Immunization Survey (sponsored by the National Immunization Program and NCHS). Using the SLAITS platform, interviews on approximately 2000 children were conducted in each state and the District of Columbia. The parent or guardian most knowledgeable about the child completed a battery of questions on health and development, health insurance coverage, access to care, utilization of health care services, presence of a medical home, family functioning, parental health, and neighborhood characteristics. Data collection began in January 2003 and continued through April 2004. Summary reports and electronic data files will be available to the public by early 2005. CONCLUSION: This is the second state and national survey jointly completed by MCHB and NCHS. It is designed to complement the 2001 National Survey of Children with Special Health Care Needs by providing data on the health of the general child population.

Centers for Disease Control and Prevention, U.S.↗

Hepatitis A vaccination options for Australia.

The epidemiology of hepatitis A is changing, with an increasing proportion of the population becoming susceptible to infection. The burden of hepatitis A is comparable to that of other vaccine-preventable diseases for which new vaccines are available. Options for vaccination include selective programmes for high-risk groups, which could involve screening prior to vaccination, or universal programmes for infants and/or adolescents. Selective programmes have been shown to be highly cost-effective if well implemented, but there is evidence that they might be poorly implemented. If a universal vaccination programme were considered for Australia, an infant programme, with doses at 18 months and 2 years, possibly with an additional adolescent programme, would be the recommended option. Universal hepatitis A vaccination for infants and/or adolescents is of comparable cost-effectiveness compared with other preventive strategies, but needs to be considered in the context of competing vaccination options.

Australia↗

Immunisation coverage in Australia corrected for under-reporting to the Australian Childhood Immunisation Register.

OBJECTIVE: To assess the level of under-reporting to the Australian Childhood Immunisation Register (ACIR) and the resulting underestimation of national immunisation coverage using ACIR data, and to correct national immunisation estimates for under-reporting. METHODS: A national population-based telephone survey was conducted in May-July 2001 of two random samples of children born in 1998 and 1999 who were recorded on the ACIR as incompletely immunised at either 12 months or 24 months of age. Parents were asked whether and when their child had received the vaccinations required to qualify as fully immunised. Survey data were then used to correct ACIR-derived coverage estimates at 12 and 24 months of age. RESULTS: Of 640 surveyed children in the 12-month group, 258 (40%) met the study definition of 'definitely immunised'. This adjusted the ACIR coverage estimate upwards by 2.7% to 94% (95% CI 93.6-94.1). Of 698 surveyed children in the 24-month group, 387 (55%) met the study definition of 'definitely immunised' at the second birthday. Adjusted coverage for doses due by 24 months was 89.8% (95% CI 89.6-90.1), 5% higher than recorded on the ACIR. CONCLUSIONS: Immunisation coverage in Australia for all scheduled vaccines due by 12 months of age is 94% and for all vaccines due by two years of age is almost 90%. The ACIR underestimates coverage by up to 5%. As the ACIR database relies on provider notification, published estimates of immunisation coverage are unlikely to rise significantly above current levels, unless mechanisms are put in place to further improve notification to the ACIR.

Australia↗

Effects of medicaid managed care on quality: childhood immunizations.

BACKGROUND: Underimmunization is distributed unevenly across populations, concentrated among the impoverished. Managed care has stimulated the development of quality indicators such as immunization rates to assess health status of populations. OBJECTIVE: To determine if enrollment in Medicaid managed care (MMC) improves quality of health care as reflected by immunization rates when compared with fee-for-service Medicaid (FFSM). DESIGN. Prospective cohort study of infants born between May 1994 and April 1995 with a 24-month follow-up period. SETTING: Urban teaching hospital and surrounding ambulatory settings. PARTICIPANTS: Consecutive sample of infants (n = 644) enrolled in MMC or FFSM. Ninety-two percent of eligible patients were enrolled, and 87% completed follow-up. MAIN OUTCOME MEASURE: Up-to-date immunization status. RESULTS: Seventy-three percent of the MMC and 72.4% of the FFSM patients were up-to-date on their immunizations: relative risk 1.01, (95% confidence interval [CI] 0.87, 1.17). No differences were found in age at immunization between the MMC and FFSM groups. After adjusting for other factors in multivariate analysis, insurance status remained unassociated with immunization status: adjusted odds ratio (OR) 1.04, (95% CI: 0.90, 1.10). Factors associated with up-to-date immunization included firstborn child, OR 2.28 (95% CI: 1.45, 3.60) and adequate maternal prenatal care, OR 2.24 (95% CI: 1.44, 3.48). Variables characterizing children less likely to be adequately immunized included father living in home with child, OR 0.53 (95% CI: 0.33, 0.85) and using private office-based primary care, OR 0.39 (95% CI: 0.23, 0.63). CONCLUSIONS: Enrollment in MMC did not improve rates of immunizations when compared with FFSM.

Child↗

A middle school immunization law rapidly and substantially increases immunization coverage among adolescents.

OBJECTIVES: This study assessed the effectiveness of a middle school vaccination requirement for raising second-dose measles, mumps, and rubella vaccine and hepatitis B vaccine coverage among adolescents. METHODS: Random-digit-dialed telephone surveys were conducted before (1998) and after (1999) the implementation of a vaccination requirement for entry into the seventh grade in San Diego, Calif. RESULTS: Vaccination coverage was higher among children subject to the vaccination requirement (seventh-grade students; 60%) than among fifth- and sixth-grade students 1 year before the requirement (13%, P <.001), and 8th- through 12th-grade students not subject to the requirement (27%, P <.0001). CONCLUSIONS: Middle school-entry vaccination requirements can rapidly and substantially raise vaccination coverage among students subject to the law.

Adolescent↗

Vaccinations in women.

Obstetricians/gynecologists who deliver primary care have an opportunity to enhance the preventive care of their patients. At the first visit with each patient, the vaccination history should be taken. Systems should be developed to remind the physician and office staff of the need for influenza and pneumococcal vaccination, including prompts for patients. One should create or use forms already developed by the CDC to record vaccination data in the patient chart. Additional information is available on the Web at www.cdc.gov/nip provided by the National Immunization Program. The Facts and Comparisons section has a Web site with links to other sources: www.immunofacts.com. All current recommendations of the ACIP are included in the reference list.

Adult↗

Viral hepatitis: from A to E, and beyond?

Identification of hepatitis viruses A-E has enabled researchers to investigate the epidemiology, pathogenesis, sequelae, and possible means of prevention of these infections. This knowledge also provides a basis for further study of the pathological significance of candidate hepatitis viruses. With improvements in hygiene in many parts of the world, hepatitis A virus infection has decreased markedly. However, this success has the unintended consequence of rendering a large percentage of the younger population susceptible to hepatitis A virus infection. Fortunately, effective active immunization for hepatitis A virus is now available. Hepatitis B remains a common condition, especially in Asia and Africa which have high prevalences of chronic infection. Chronic hepatitis B carriers serve as reservoirs of infection for the community and are at risk of chronic liver disease and hepatocellular carcinoma. A mass immunization program in Taiwan has been remarkably successful in reducing the prevalence of chronic hepatitis B infection. Genotypes of the hepatitis B viruses may be associated with the severity of liver disease and the responses to therapies. Hepatitis C is another important cause of death worldwide. The infection easily becomes refractory and the chronicity contributes to the development of cirrhosis and hepatocellular carcinoma. Although no effective immunization is currently available for hepatitis C, it can be controlled by preventative measures and recently developed interferon-based treatments, especially in combination with ribavirin. The prevalence of hepatitis D has markedly decreased in the last decade and new cases are now rarely encountered. Hepatitis E is endemic in limited areas and travel to these areas appears to be the main risk factor for contracting the infection. Several new candidate hepatitis viruses have been identified, including GB virus-C, TT virus, and SEN virus, but none of these has been shown to cause hepatitis, and they may be passenger viruses.

Global Health↗

Improving the monitoring of immunization services in Kyrgyzstan.

Following the disbanding of the Soviet Union in 1991, the government of Kyrgyzstan was unable to maintain the previous level of health services. To revitalize the health services, the Ministry of Health (MOH) first focused on improving their immunization services, including the immunization component of the Health Management Information System (HMIS). Secondly, to increase immunization coverage, the MOH set as a priority the elimination of prescribing false contraindications to immunization. To accomplish both goals, the MOH updated the national immunization policies and established a more effective structure for managing immunization services. To support the MOH, the US Agency for International Development (USAID) Resources for Child Health (REACH) and Basic Support for Institutionalizing Child Survival (BASICS) projects provided technical assistance through a resident coordinator and consultants, and by organizing an international seminar. The improvements extended beyond systems and forms, but, instead, emphasized monitoring by the frontline health worker and supervising the quality of health information. To accomplish their objectives, the MOH appointed a Working Group to define the problems, revise record-keeping procedures, and develop monitoring tools. This group, representing both national and local levels, was composed of MOH epidemiologists, paediatricians and a management information specialist. To reduce the burden of excessive record-keeping and reporting requirements, the Working Group identified four key indicators for the service delivery level: (1) DPT3 immunization coverage rates for children less than 1 year of age; (2) contraindication rates for DPT; (3) usage of DPT vaccine; and (4) daily refrigerator temperatures. Additional indicators were included at district and provincial levels. After a successful 1-year trial, the MOH implemented the revised HMIS nationally. Not only did the quality of the information system improve, but the new approach provided visible evidence, from facility to national levels, that the MOH was approaching their objective of reducing contraindication rates for DPT immunizations to 5% or less, and that vaccine wastage could be substantially reduced. The project demonstrated that giving health workers the basic epidemiologic skills to monitor their own work measurably improved the quality of the data, and by acquiring the new skills, the workers developed a sense of pride in their work.

Child↗

[Mumps in Poland in 2002].

In 2002, 39,978 cases of mumps were reported in Poland. The incidence (104.6 per 100,000) was higher then in 2001 (43.3), which corresponds to a periodical increase of mumps incidence occurring in Poland every 3-4 years. This year's peak is much lower than the previous ones, which can be attributed to the growing vaccine coverage. Even though the mumps vaccine was not included into the national immunization program, the coverage in the 3-year old children reached in 2002 35.5%. Approximately 3.5% of cases were hospitalized (1400) and no mumps deaths were reported. Children 5-9 years old constituted the most affected age group (incidence 965.2 per 100,000). In Poland the MMR vaccine was recommended on voluntary basis in place of measles vaccine for children in their 2nd and 7th year of age. Immunization of 2-years old children is mandatory beginning in 2004.

Adolescent↗

Immunization strategies for the elimination of hepatitis B.

Rates of hepatitis B infection have remained high despite immunization programs for infants of HBsAg-positive mothers and individuals considered to be at high risk for exposure. The Centers for Disease Control and Prevention and the American Academy of Pediatrics have provided new recommendations for a comprehensive strategy to eliminate hepatitis B virus. The first priority is the prenatal screening of all pregnant women and follow-up vaccination of all infants. The second is the immunization of at-risk adolescents and adults. Ultimately, it is hoped that all adolescents will be immunized when feasible and that the incidence of hepatitis B virus infection will decline. Primary care providers have an important role in the provision of public education about hepatitis B and in the implementation of these new recommendations.

Adolescent↗

Immunization against infectious disease.

Mortality and morbidity from infectious diseases in the United States have declined more than 90 percent since 1900. Factors believed to be responsible for this decline include changes in the natural history of disease, sanitation, quarantine measures, control of nonhuman vectors, antibacterial drugs, and immunization. The contributions of each of these factors differ among the various infectious diseases; except for smallpox and diphtheria control, immunization had little effect until after World War II. The success of present and future immunization programs is endangered by public and physician complacency and by complex legal and ethical problems related to informed consent and responsibility for rare, vaccine-related injury.

Adolescent↗

[Mumps in Poland in 2003].

In 2003, 87,336 cases of mumps were reported in Poland. The incidence (228,7 per 100,000) was higher then in 2002(104.6), which corresponds to a periodical increase of mumps incidence. According to the natural periodicity the peak incidence would be expected to take place in 2002. The increase of mumps incidence in 2003, still lower however then the previous peaks, can be attributed to the prolongation of the epidemics cycle usually occurring with growing vaccine coverage. Even though the mumps vaccine was not included into the national immunization program, the coverage in 3-year old children in 2003 reached 39.6%. Approximately 4.6% of cases were hospitalized (4,056) and no mumps deaths were reported. Children 5-9 year old constituted the most affected age group (incidence 2,133.1 per 100,000). In Poland the MMR vaccine was recommended on voluntary basis in place of measles vaccine for children in their 2nd and 7th year of age. Immunization of 2-years old children is mandatory beginning in 2004.

Adolescent↗

Conjugate vaccines--a breakthrough in vaccine development.

The encapsulated bacteria Streptococcus pneumoniae (the pneumococcus), Neisseria meningitidis (the meningococcus) and Haemophilus influenzae type b (Hib) are the main causes of purulent meningitis, the peak incidence of which is seen in the first two years of life. The polysaccharide capsule of these bacteria is an essential virulence determinant, and antibodies to it are protective, suggesting that a polysaccharide vaccine could prevent these diseases. The young child is, however, unable to respond with antibody production to these polysaccharides, making such vaccines useless in infancy. Conjugation of the polysaccharide to a protein carrier has proven a way to solve the problem. Immunization of infants with such a Hib conjugate vaccine was shown in 1987 to result in the desired antibody production and protection from Hib meningitis and bacteremia. The Hib vaccine is now a part of national infant immunization programs in large parts of Europe, the Americas and Australia, and has resulted in the virtual disappearance of Hib disease from these areas. A group C meningococcal and 7-valent pneumococcal vaccine, available since 2000, are likewise proving highly effective in preventing bacteremic disease. Further advantages of the conjugate vaccines are their ability to elicit immunologic memory and to reduce asymptomatic carriage of the bacteria, resulting in marked herd immunity. This paper was delivered as a lecture in January 2003 in Bangkok on the occasion of the Prince Mahidol Award for a life's work in the field of vaccinology.

Bacterial Vaccines↗

Congenital rubella syndrome in Haiti (Short communication).

OBJECTIVE: To determine if there is an unrecognized problem of congenital rubella syndrome (CRS) in Haiti, a country without a national rubella immunization program. METHODS: During March 2001 and June 2001, screening physicals were conducted on approximately 80 orphans at three orphanages in Haiti that accept disabled children. Children were classified as probable CRS cases based on established clinical criteria. Photo documentation of findings was obtained whenever possible. RESULTS: Six children met the criteria for probable CRS. Using data from surrounding Caribbean countries and from the United States of America prior to rubella immunization, we estimated that there are between 163 and 440 new cases of CRS per year in Haiti. CONCLUSIONS: CRS exists in Haiti, but its presence is generally unrecognized. A national rubella immunization policy should be considered.

Adolescent↗