Pagina richiesta non valida
Objective: Current guidelines recommend that egg-allergic patients
receive an influenza vaccine skin test before the influenza vaccine. This
study evaluated the safety of bypassing the skin test and administering
graded doses of influenza vaccine to egg-allergic children.
Methods: We conducted a retrospective chart-review study of eggallergic patients aged 6 months to 18 years who received the vaccine skin test and/or a 2-dose graded influenza vaccine. Between influenza seasons 2002–2003 and 2006 –2007, egg-allergic patients underwent a vaccine skin test before influenza vaccine administration. Starting in 2006 –2007, the skin test was removed from our protocol and eggallergic patients received the influenza vaccine in 2 graded doses. All vaccinated patients were observed for adverse reactions.
Results: Two hundred sixty-one egg-allergic patients were evaluated for influenza vaccine administration, and 171 went on to receive the vaccine. Of the 56 patients who received the skin test before the influenza vaccine, 95% (exact 95% confidence interval [CI]: 85.1–98.9) tolerated the vaccine without a serious adverse reaction. This rate was unchanged after the vaccine skin test was removed from the protocol. Of the 115 patients who received the vaccine without a preceding skin test, 97% (exact 95% CI: 91.3–99.0) tolerated the vaccine without serious adverse reaction. The tolerance rate ratio was 1.01 (95% CI: 0.97–1.06).
Conclusions: The results of our study suggest that egg-allergic patients without anaphylaxis to egg may safely receive the influenza vaccine in a 2-dose, graded fashion without a vaccine skin test.
Safety of Influenza Vaccine Administration in Egg-Allergic Patients - Pediatrics 2010;125;e1024-e1030;
Erica Y. Chung, Lin Huang and Lynda Schneider
Objective: To determine if the incidence of empyema among children in the United States has changed since the introduction of the pneumococcal conjugate vaccine in 2000.
Methods: We used the nationally representative Kids' Inpatient Database to estimate the annual total number of hospitalizations of children ≥18 years of age that were associated with empyema in 1997, 2000, 2003, and 2006. Using US Census data, estimated counts were converted into annual incidence rates per 100000 children. Incidence rates were compared between 1997 and later years to determine the impact of pneumococcal conjugate vaccine on hospitalization rates.
Results: During 2006, an estimated total of 2898 (95% confidence interval [CI]: 2532–3264) hospitalizations of children ≤18 years of age in the United States were associated with empyema. The empyema-associated hospitalization rate was estimated at 3.7 (95% CI: 3.3–4.2) per 100000 children, an increase of almost 70% from the 1997 empyema hospitalization rate of 2.2 (95% CI: 1.9–2.5) per 100000. The rate of complicated pneumonia (empyema, pleural effusion, or bacterial pneumonia requiring a chest tube or decortication) similarly increased 44%, to 5.5 (95% CI: 4.8–6.1) per 100000. The rate of bacterial pneumonia decreased 13%, to 244.3 (95% CI: 231.1–257.5) per 100000. The rate of invasive pneumococcal disease (pneumonia, sepsis, or meningitis caused by Streptococcus pneumoniae) decreased 50%, to 6.3 (95% CI: 5.7–6.9) per 100000.
Conclusions: Among children ≤18 years of age, the annual empyema-associated hospitalization rates increased almost 70% between 1997 and 2006, despite decreases in the bacterial pneumonia and invasive pneumococcal disease rates. Pneumococcal conjugate vaccine is not decreasing the incidence of empyema.
Empyema Hospitalizations Increased in US Children Despite Pneumococcal Conjugate Vaccine - Pediatrics (doi:10.1542/peds.2009-0184)
Lepoutre A., Varon E., Georges S., Gutmann L., Lévy-Su-Ting T. Li, MD, MPH and Daniel J. Tancredi, PhD
Department of Pediatrics, University of California at Davis, Sacramento, California
Context: Pneumococcal conjugate bacterial vaccines that are able to prevent invasive disease and mucosal infections have been developed.
Objective: A meta-analysis of published data from trials on pneumococcal conjugate vaccine was performed to determine the efficacy in reducing the incidence of invasive disease caused by Streptococcus pneumoniae, pneumonia, and acute otitis media in healthy infants younger than 24 months.
Methods: A systematic search of the literature was conducted. Controlled clinical trials had to compare the protective efficacy of the pneumococcal conjugate vaccine in reducing the incidence of invasive disease caused by S pneumoniae, pneumonia, and acute otitis media in healthy infants with placebo or control vaccines. Information was extracted by using a standardized protocol.
Results: The efficacy of pneumococcal conjugate vaccine in the reduction of invasive pneumococcal disease was 89% involving vaccine serotypes in both the intention-to-treat and per-protocol analyses and ranged from 63% to 74% for all serotypes. The efficacy to prevent acute otitis media sustained by vaccine serotypes was 55% in the intention-to-treat and 57% in the per-protocol analyses, whereas it was 29% to prevent otitis involving all serotypes in the per-protocol analysis. Finally, in the intention-to-treat and per-protocol analyses, the efficacy to prevent clinical pneumonia was 6% and 7%, respectively, whereas for the prevention of radiograph-confirmed pneumonia it was 29% and 32%, respectively.
Conclusions: The pneumococcal conjugate vaccine produces a significant effect regarding prevention of invasive pneumococcal disease. Results on prevention of otitis or pneumonia have been less striking, but considering the high burden of these diseases in infants, even a low efficacy has potential for tremendous impact on the health of infants in developing and industrialized countries.
Efficacy of Pneumococcal Vaccination in Children Younger Than 24 Months: A Meta-Analysis - Pediatrics Vol. 123 No. 6 June 2009, pp. e1103-e1110 (doi:10.1542/peds.2008-3422)
Maria Pavia, MD, MPHa, Aida Bianco, MDa, Carmelo G. A. Nobile, MDa, Paolo Marinelli, MDb and Italo F. Angelillo, DDS, MPHb
a Department of Hygiene, Medical School, University of Catanzaro "Magna Græcia," Catanzaro, Italy
b Department of Public, Clinical, and Preventive Medicine, Second University of Naples, Naples, Italy
Objective: Because 7-valent pneumococcal conjugate vaccine (PCV7) is highly efficacious, pneumococcal infections in vaccinated children raise concerns about immunologic disorders. We characterized a case series of US children in whom invasive pneumococcal infections developed despite vaccination.
Study design: We reviewed invasive (sterile site) pneumococcal infections in children aged <5 years who had received >/=1 PCV7 dose as identified from October 2001 to February 2004 through national passive surveillance and the Centers for Disease Control and Prevention's Active Bacterial Core surveillance. Vaccine serotype infections were considered breakthrough cases; the subset of breakthrough cases occurring in children who completed an age-appropriate vaccination series were considered PCV7 failures.
Results: We identified 753 invasive infections; 155 infections (21%) were breakthrough cases, predominantly caused by serotypes 6B (n = 50, 32%) and 19F (n = 45, 29%). The proportion of breakthrough cases decreased with the increasing number of PCV7 doses received (P < .001, X(2) for linear trend). Children with co-morbid conditions accounted for 31% of breakthrough infections. Twenty-seven cases (4%) were classified as vaccine failures. Most failures (71%) occurred in children who were vaccinated according to catch-up schedules; 37% had co-morbid conditions.
Conclusion: Invasive pneumococcal infections identified in vaccinated U.S. children were primarily caused by disease resulting from serotypes not covered with PCV7, rather than failure of the vaccine. Incomplete vaccination and co-morbid conditions likely contribute to breakthrough vaccine-type pneumococcal infections.
Invasive Pneumococcal Infections among Vaccinated Children in the United States - The Journal of Pediatrics - doi:10.1016/j.jpeds.2009.10.008
Park SY, Van Beneden CA, Pilishvili T, Martin M, Facklam RR, Whitney CG; for the Active Bacterial Core surveillance team.
Office of Workforce and Career Development, Centers for Disease Control and Prevention, Atlanta, GA; Respiratory Diseases Branch, Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA.
Vaccination with the 7-valent pneumococcal conjugate vaccine (PCV) has been recommended in France since 2003 for children under the age of two years who are at risk due to medical or living conditions. From 2006, the recommendation has been extended to all children under two years. The impact of PCV introduction on the incidence of pneumococcal meningitis and bacteraemia and on the serotype distribution in French children and other age-groups was assessed using laboratory surveillance data. The coverage with three doses of PCV was 44% in children aged 6-12 months in 2006. From 2001/2002 to 2006, the incidence of pneumococcal meningitis decreased from 8.0 to 6.0 cases per 100,000, and the incidence of pneumococcal bacteraemia decreased from 21.8 to 17.5 cases per 100,000 in children under the age of two years. For the vaccine strains, the incidence of pneumococcal meningitis and bacteraemia decreased from 20,4 to 6.0 cases per 100,000, while the incidence of pneumococcal meningitis and bacteraemia due to non-vaccine strains increased from 9.4 to 17.5 cases per 100,000 in this time period. The incidence in older children and adults did not decrease. Further expansion of PCV coverage is expected to increase the impact of the vaccination in both children and adults. However, the fact that cases caused by vaccine serotypes have been partially substituted by cases of non-vaccine serotypes is likely to reduce the overall benefit of PCV in France, should this early observation be confirmed in the future.
Impact of infant pneumococcal vaccination on invasive pneumococcal diseases in France, 2001-2006
Lepoutre A., Varon E., Georges S., Gutmann L., Lévy- Bruhl D.
Euro Surveill. 2008 Aug 28;13(35). pii: 18962
Streptococcus pneumoniae is
the leading bacterial cause of community-acquired pneumonia
hospitalizations and an important cause of bacteremia and meningitis,
especially among young children and older adults. A 7-valent
pneumococcal conjugate vaccine (PCV7) was licensed and the Advisory
Committee on Immunization Practices formulated recommendations for its
use in infants and children in February 2000.
Vaccination coverage rapidly increased during the second half of 2000, in part through funding by CDC's Vaccines for Children program. Subsequently, active population- and laboratory-based surveillance demonstrated substantial reductions in invasive pneumococcal disease (IPD) among children and adults. In addition, decreases in hospitalizations and ambulatory-care visits for all-cause pneumonia also were reported. To gauge whether the effects of PCV7 on reducing pneumonia continue, CDC is monitoring pneumonia hospitalizations by using data from the Nationwide Inpatient Sample.
This report provides an update for 2005 and 2006, the most recent years for which information is available. In 2005 and 2006, the incidence rates for all-cause pneumonia hospitalizations among children aged <2 years were 9.1 per 1,000 and 8.1 per 1,000, respectively.
In 2006, the rate for all-cause pneumonia among children aged <2 years was approximately 35% lower than during 1997--1999. Most of this decrease occurred soon after the vaccine was licensed in 2000, and the rates have remained relatively stable since then. The rate for all-cause pneumonia among children aged 2--4 years did not change after PCV7 licensure and has remained stable. Continued monitoring of pneumonia- related hospitalizations among children is needed to track the effects of pneumococcal immunization programs.
Pneumonia Hospitalizations Among Young Children Before and After Introduction of Pneumococcal Conjugate Vaccine --- United States, 1997--2006
Centers for Disease Control and Prevention (CDC).
MMWR Morb Mortal Wkly Rep. 2009 Jan 16;58(1):1-4
Epidemiological study of bacterial meningitis, particularly those forms susceptible to vaccination, is an indispensable tool in choosing vaccination strategies. Lombardy Region, where approximately 20% of the Italian population resides, has conducted an in-depth study on invasive meningococcal diseases and pneumococcal meningitis using available health statistics and performing a control of single cases to achieve complete knowledge of the phenomenon. The results, relating to the period 2000-2006, indicate limited incidence rates both for the general population and childhood age groups that do not justify hypotheses of a universal offering of the specific vaccines. However, the healthcare system must equip itself with additional tools for the identification of the serogroups and serotypes responsible for disease as a further support for possible choices modifying the current vaccination policies.
Epidemiology of bacterial meningitis in Lombardy Region in the period 2000-2006
Pavan A, Antinori S, Belloni A, Boccazzi A, Castelli F, Gramegna M, Magliano E, Marone P, Montomoli C, Tinelli M, Zuccotti G, Macchi L
New Microbiol 2007;30(3):340-5
BACKGROUND: The incidence of and mortality from invasive pneumococcal disease are significantly higher in children with sickle cell disease than in the general pediatric population. The objective of this population-based study was to assess the effect of pneumococcal conjugate vaccine on rates of invasive pneumococcal disease among children with sickle cell disease.
PATIENTS AND METHODS: Records, including the history of pneumococcal conjugate vaccine administration, of 1247 children born after 1983 residing in metropolitan Atlanta, Georgia, with confirmed hemoglobinopathies were linked to an active surveillance database for invasive pneumococcal disease for the period of January 1, 1995, through January 1, 2003. The incidence of invasive pneumococcal disease and the percentage of rate reduction were estimated before and after pneumococcal conjugate vaccine licensure. Survival analysis was used to estimate the effect of pneumococcal conjugate vaccine on invasive pneumococcal disease rates while accounting for herd immunity.
RESULTS: A significant decline in invasive pneumococcal disease in children with sickle cell disease < or = 10 years of age was noted after pneumococcal conjugate vaccine licensure, from 1.7 infections per 100 person-years (1995-2000) to 0.5 infections per 100 person-years (2001-2002), which represents a 68% reduction. The effectiveness of > or = 1 dose of pneumococcal conjugate vaccine was estimated by crude analysis to be 84.5% and by stratified survival analysis to be 81.4% when controlling for the presence of herd immunity in the 2 years after pneumococcal conjugate vaccine licensure. Serotype 6A invasive pneumococcal disease represented 36% of invasive pneumococcal disease before pneumococcal conjugate vaccine licensure and 0% after pneumococcal conjugate vaccine licensure, suggesting a protective effect against this pneumococcal conjugate vaccine-related serotype.
CONCLUSIONS: Invasive pneumococcal disease significantly decreased in children with sickle cell disease < or = 10 years of age after pneumococcal conjugate vaccine licensure. Pneumococcal conjugate vaccine was effective even when controlling for herd immunity. Extending guideline recommendations for catch-up vaccination beyond 4 years of age should be considered.
Effectiveness of the 7-valent pneumococcal conjugate vaccine in children with sickle cell disease in the first decade of life
Adamkiewicz TV, Silk BJ, Howgate J, Baughman W, Strayhorn G, Sullivan K, Farley MM
Pediatrics 2008 Mar;121(3):562-9
Background. Although hospitalizations due to invasive pneumococcal disease decreased after routine vaccination of young children with a 7-valent pneumococcal conjugate vaccine (PCV7) began in 2000, information on the trends in pneumococcal meningitis is limited.
Methods. We estimated national trends in rates of hospitalization for pneumococcal meningitis, using data from the Nationwide Inpatient Sample, 1994-2004. Pneumococcal meningitis cases and deaths were identified on the basis of the International Classification of Diseases, Ninth Edition, Clinical Modification coded primary discharge diagnosis, and rates were calculated using US Census data as denominators. The year 2000 was considered to be a transition year, and the average annualized rate after PCV7 introduction (2001-2004) was compared with that during the baseline years (1994-1999).
Results. During 1994-2004, there were 21,396 hospitalizations and 2684 deaths (12.5%) due to pneumococcal meningitis in the United States. In children aged <2 years, the average annualized rates of pneumococcal meningitis hospitalizations per 100,000 population decreased from 7.7 in 1994-1999 to 2.6 in 2001-2004 (change, -66.0%; 95% confidence interval [CI], -73.5% to -56.3%). Among children aged 2-4 years, the hospitalization rate decreased from 0.9 to 0.5 per 100,000 (change, -51.5%; 95% CI, -66.9% to -28.9%). Average rates also decreased by 33.0% (95% CI, -43.4% to -20.9%) among adults aged >/=65 years. After PCV7 introduction (2001-2004), an estimated 1822 and 573 pneumococcal meningitis hospitalizations were prevented in persons aged <5 years and >/=65 years, respectively. Overall, an estimated 3330 pneumococcal meningitis hospitalizations and 394 deaths were prevented in persons of all ages during 2001-2004 in the United States.
Conclusion. After implementation of routine childhood vaccination with PCV7, hospitalizations for pneumococcal meningitis decreased significantly for both children and adults. Most pneumococcal meningitis cases now occur among adults.
Changing Epidemiology of Pneumococcal Meningitis after the Introduction of Pneumococcal Conjugate Vaccine in the United States
Tsai CJ, Griffin MR, Nuorti JP, Grijalva CG.
Clin Infect Dis 2008 Apr 23
OBJECTIVES:To explore the relation between study concordance, take home message, funding, and dissemination of comparative studies assessing the effects of influenza vaccines.
DESIGN: Systematic review without meta-analysis.
DATA EXTRACTION: Search of the Cochrane Library, PubMed, Embase, and the web, without language restriction, for any studies comparing the effects of influenza vaccines against placebo or no intervention. Abstraction and assessment of quality of methods were carried out.
DATA SYNTHESIS: We identified 259 primary studies (274 datasets). Higher quality studies were significantly more likely to show concordance between data presented and conclusions (odds ratio 16.35, 95% confidence interval 4.24 to 63.04) and less likely to favour effectiveness of vaccines (0.04, 0.02 to 0.09). Government funded studies were less likely to have conclusions favouring the vaccines (0.45, 0.26 to 0.90). A higher mean journal impact factor was associated with complete or partial industry funding compared with government or private funding and no funding (differences between means 5.04). Study size was not associated with concordance, content of take home message, funding, and study quality. Higher citation index factor was associated with partial or complete industry funding. This was sensitive to the exclusion from the analysis of studies with undeclared funding.
CONCLUSIONS: Publication in prestigious journals is associated with partial or total industry funding, and this association is not explained by study quality or size.
Relation of study quality, concordance, take home message, funding, and impact in studies of influenza vaccines: systematic review
T. Jefferson, C. Di Pietrantonj, M. G. Debalini, A. Rivetti, V. Demicheli,
BACKGROUND: Influenza vaccination is recommended for asthmatic patients in many countries as observational studies have shown that influenza infection can be associated with asthma exacerbations, but influenza vaccination itself has the potential to adversely affect pulmonary function. A recent overview concluded that there was no clear benefit of influenza vaccination in patients with asthma but this conclusion was not based on a systematic search of the literature. OBJECTIVES: Whilst influenza may cause asthma exacerbations, there is controversy about the use of influenza vaccinations, since they may precipitate an asthma attack in some people. The objective of this review was to assess the efficacy of influenza vaccination in children and adults with asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register and checked reference lists of articles. The last search was carried out in September 2007. SELECTION CRITERIA: Randomised trials of influenza vaccination in children (over two years of age) and adults with asthma. Studies involving people with chronic obstructive pulmonary disease were excluded. DATA COLLECTION AND ANALYSIS: Inclusion criteria and assessment of trial quality were applied by two reviewers independently. Data extraction was done by two reviewers independently. Study authors were contacted for missing information. MAIN RESULTS: Nine trials were initially included. Four of these trials were of high quality. Six further articles have been included in three updates (Bueving 2003; Castro 2001; Fleming 2006; Redding 2002; Reid 1998). The included studies covered a wide diversity of people, settings and types of influenza vaccination, but data from the more recent studies that used similar vaccines have been pooled.Benefits: Bueving 2003 studied 696 children with asthma and did not demonstrate a significant reduction in influenza related asthma exacerbations (Risk Difference 0.01; 95% confidence interval -0.02 to 0.04).Harms: The pooled results of two trials involving 2306 people with asthma did not demonstrate a significant increase in asthma exacerbations in the two weeks following influenza vaccination (Risk Difference 0.00; 95% confidence interval -0.02 to 0.02). AUTHORS' CONCLUSIONS: Uncertainty remains about the degree of protection vaccination affords against asthma exacerbations that are related to influenza infection. Evidence from recently published trials indicates that there is no significant increase in asthma exacerbations immediately after vaccination (at least with inactivated influenza vaccination). There is concern regarding possible increased wheezing and hospital admissions in infants given live intranasal vaccination..
Vaccines for preventing influenza in people with asthma
Cates C, Jefferson T, Rowe B.
Cochrane Database Syst Rev 2008;(2):CD000364.
L'Organizzazione Mondiale della Sanità (OMS), nell'ambito del "Piano Salute per Tutti entro l'anno 2000", aveva adottato il Programma Esteso di Immunizzazione (EPI), stabilendo obiettivi per il controllo, l'eliminazione o l'eradicazione di alcune malattie prevenibili con vaccino. Ai fini del raggiungimento di tali obiettivi strategici, erano stati successivamente definiti e periodicamente aggiornati gli obiettivi operativi, consistenti nel raggiungimento, per il ciclo primario di immunizzazione, di coperture superiori al 95% prima dei due anni per difterite, tetano, polio e superiori al 99% per morbillo, rosolia e parotite. Gli obiettivi operativi dell'OMS sono stati in gran parte recepiti dal Piano Sanitario Nazionale 1998-2000 che, nell'Obiettivo II "Contrastare le principali patologie", aveva stabilito che la copertura vaccinale per la popolazione di età inferiore a 24 mesi, anche immigrata, dovesse raggiungere almeno il 95% su tutto il territorio nazionale per tutte le vaccinazioni obbligatorie (difterite, tetano, polio, epatite B) e raccomandate (pertosse, morbillo, parotite e rosolia, Haemophilus influenzae B). L'Ufficio V del Ministero della Salute, al termine del periodo di riferimento del PSN, ha condotto una valutazione sull'effettivo conseguimento di tali obiettivi operativi. I risultati sono esposti in tabelle e grafici riassuntivi relativi al periodo 2000-2006.
Vaccinazioni (PNV) vengono redatti dalla Commissione Nazionale Vaccini, cui partecipano rappresentanti delle Regioni e Province Autonome, del Ministero della Salute, dell’Istituto Superiore di Sanità e delle Società scientifiche. L’attuale assetto normativo (Modifica titolo V della Costituzione, Legge Costituzionale n. 3 del 18 ottobre 2001) prevede che la tutela della salute sia materia “concorrente” tra Stato e Regioni. Le Regioni, cioè, hanno la proprietà legislativa, salvo che per la determinazione dei principi fondamentali, riservata alla legislazione dello Stato. I documenti che riguardano le strategie vaccinali, incluso il Piano Nazionale Vaccini, per diventare operativi devono quindi essere approvati dalla Conferenza Stato-Regioni...
Vaccini e devolution: è possibile superare la diversità di offerta tra Regioni?
Marta Luisa Ciofi degli Atti
Medico e Bambino 2008;27(2):75-77
The 7-valent anti-pneumococcal conjugate vaccine (PCV), anti-meningococcal C-conjugate vaccine (MenC) and varicella vaccine have been recently introduced in EU. In Italy, these vaccines have so far been recommended for use in specific groups. Since the health system is decentralised, the Regional Health Authorities (RHAs) can decide to recommend vaccination for other target populations. We conducted a survey to describe the recommendations on these vaccines currently in place in the 21 Italian regions. In November 2005, a standardised questionnaire was sent to RHAs, including information on the existence of regional recommendations, vaccination target population, and whether vaccines were provided free of charge, or at a reduced cost compared to pharmacies. Information reported in the questionnaires were followed up in May 2006. All 21 regions completed and returned the questionnaire and were contacted for follow-up. Recommendations about at least one of the three vaccines were present in 20 out of 21 regions. All included free of charge PCV offering to specific groups, while MenC and varicella immunisations were recommended in 17 and 19 regions, respectively. Recommendations for other individuals varied greatly by area: free of charge PCV and MenC vaccinations targeting all infants have been recommended in nine regions, and varicella vaccination targeting children in the second year of life in three regions. These different recommendations can lead to marked variation in vaccination coverage rates observed through the country, with a consequent different level of disease control. It is thus crucial to properly monitor vaccination coverage rates for PCV, MenC and varicella, as these are not routinely collected at the national level.
Pneumococcal conjugate, meningococcal C and varicella vaccination in Italy
F D’Ancona, V Alfonsi, M Caporali, A Ranghiasci, ML Ciofi degli Atti, on behalf of the Regional referents for infectious diseases and vaccinations
Eurosurveillance, Volume 12, Issue 2, 01 February 2007
In accordance with its mandate to provide guidance to Member States on health policy matters, WHO is issuing a series of regularly updated position papers on vaccines and vaccines combinations against diseases that have an international public health impact. These papers, which are concerned primarily with the use of vaccines in largescale immunization programmes, summarize essential background information on their respective diseases and vaccines and conclude by giving WHO’s current position on their use in the global context. The papers have been reviewed by a number of experts within and outside WHO and, since April 2006, they have been reviewed and endorsed by WHO’s Strategic Advisory Group of Experts (SAGE) on immunization. The position papers are designed for use mainly by national public health offi - cials and managers of immunization programmes. However, they may also be of interest to international funding agencies, the vaccine manufacturing industry, the medical community, the scientific media and the public...
Il vaccino tetravalente contro il papillomavirus umano (HPV), virus a trasmissione sessuale correlato allo sviluppo della neoplasia della cervice uterina, è stato approvato nel giugno 2006 dalla Food and Drug Administration (FDA) americana e tre mesi dopo dall’European Agency for the Evaluation of Medicinal Products (EMEA) per l’Europa. Il Ministero della Salute italiano ha deciso di rendere il vaccino disponibile nelle farmacie già da questa primavera e di proporlo dal prossimo anno gratuitamente a tutte le dodicenni tramite, come nel caso dei vaccini destinati all’età infantile, i servizi territoriali e i pediatri di comunità...
Vaccinazione anti-HPV: alcuni interrogativi per il pediatra
Editoriale Medico e Bambino 2007;26(5):279-280
Il vaccino per il cancro della cervice
a cura dell'Agenzia Italiana del Farmaco, AIFA
Medico e Bambino pagine elettroniche 2007;10(4)
Il vaccino contro i papillomavirus per la prevenzione del cancro del collo dell'utero e dei conditomi acuminati
di Giorgio Bartolozzi
Medico e Bambino pagine elettroniche 2007;10(2)
Il vaccino anti-Rotavirus, sperimentato e commercializzato nel 1998, è stato ritirato dal commercio perché la sua somministrazione risultava associata a un maggior rischio a breve termine di invaginazione intestinale. Sebbene questo effetto sia stato in seguito ridimensionato, quel vaccino non è stato più riammesso. Peraltro, all’inizio dello scorso anno, due nuovi vaccini (ingegnerizzati), efficaci e sicuri, sono stati messi in commercio negli Stati Uniti e nell’America Latina, dopo larghissima e accurata sperimentazione. L’argomento merita un’approfondita farmacoriflessione.
Quale? quando? perché? per chi?
Farmacoriflessioni Medico e Bambino 2007;26(4):173-175
Linee guida per l'uso del vaccino pentavalente contro i rotavirus (RotaTec)
di G. Bartolozzi, Medico e Bambino pagine elettroniche 2007; 10(3)
Background: Rotavirus gastroenteritis causes many deaths in infants in sub-Saharan Africa. Because rotavirus vaccines have proven effective in developed countries but had not been tested in developing countries, we assessed efficacy of a pentavalent rotavirus vaccine against severe disease in Ghana, Kenya, and Mali between April, 2007, and March, 2009.
Methods: In our multicentre, double-blind, placebo-controlled trial, undertaken in rural areas of Ghana and Kenya and an urban area of Mali, we randomly assigned infants aged 4—12 weeks without symptoms of gastrointestinal disorders in a 1:1 ratio to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age. Infants with HIV infection were not excluded. Randomisation was done by computer-generated randomisation sequence in blocks of six. We obtained data for gastrointestinal symptoms from parents on presentation to health-care facilities and clinical data were obtained prospectively by clinicians. The primary endpoint was severe rotavirus gastroenteritis (Vesikari score ≥11), detected by enzyme immunoassay, arising 14 days or more after the third dose of placebo or vaccine to end of study (March 31, 2009; around 21 months of age). Analysis was per protocol; infants who received scheduled doses of vaccine or placebo without intervening laboratory-confirmed naturally occurring rotavirus disease earlier than 14 days after the third dose and had complete clinical and laboratory results were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT00362648.
Findings: 5468 infants were randomly assigned to receive pentavalent rotavirus vaccine (n=2733) or placebo (n=2735). 2357 infants assigned to vaccine and 2348 assigned to placebo were included in the per-protocol analysis. 79 cases of severe rotavirus gastroenteritis were reported in 2610·6 person-years in the vaccine group, compared with 129 cases in 2585·9 person-years in the placebo group, resulting in a vaccine efficacy against severe rotavirus gastroenteritis of 39·3% (95% CI 19·1—54·7, p=0·0003 for efficacy >0%). Median follow-up in both groups was 527 days starting 14 days after the third dose of vaccine or placebo was given. 42 (1·5%) of 2723 infants assigned to receive vaccine and 45 (1·7%) of 2724 infants assigned to receive placebo had a serious adverse event within 14 days of any dose. The most frequent serious adverse event was gastroenteritis (vaccine 17 [0·6%]; placebo 17 [0·6%]).
Interpretation: Pentavalent rotavirus vaccine is effective against severe rotavirus gastroenteritis in the first 2 years of life in African countries with high mortality in infants younger than 5 years. We support WHO's recommendation for adoption of rotavirus vaccine into national expanded programmes on immunisation in Africa.
Funding: PATH (GAVI Alliance grant) and Merck.
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial
The Lancet, Volume 376, Issue 9741, Pages 606 - 614, 21 August 2010
Prof George E Armah PhD a, Prof Samba O Sow MD, Robert F Breiman MD, Michael J Dallas PhD, Milagritos D Tapia MD, Daniel R Feikin MD, Prof Fred N Binka MD, A Duncan Steele PhD, Kayla F Laserson ScD, Nana A Ansah MD, Prof Myron M Levine MD, Kristen Lewis MPH, Michele L Coia BS, Margaret Attah-Poku MPhil, Joel Ojwando BSc, Stephen B Rivers MBA, John C Victor PhD, Geoffrey Nyambane MA, Abraham Hodgson MD, Florian Schödel MD, Max Ciarlet PhD, Dr Kathleen M Neuzil MD
Background: Rotavirus vaccine has proved effective for prevention of severe rotavirus gastroenteritis in infants in developed countries, but no efficacy studies have been done in developing countries in Asia. We assessed the clinical efficacy of live oral pentavalent rotavirus vaccine for prevention of severe rotavirus gastroenteritis in infants in Bangladesh and Vietnam.
Methods: In this multicentre, double-blind, placebo-controlled trial, undertaken in rural Matlab, Bangladesh, and urban and periurban Nha Trang, Vietnam, infants aged 4—12 weeks without symptoms of gastrointestinal disorders were randomly assigned (1:1) to receive three oral doses of pentavalent rotavirus vaccine 2 mL or placebo at around 6 weeks, 10 weeks, and 14 weeks of age, in conjunction with routine infant vaccines including oral poliovirus vaccine. Randomisation was done by computer-generated randomisation sequence in blocks of six. Episodes of gastroenteritis in infants who presented to study medical facilities were reported by clinical staff and from parent recollection. The primary endpoint was severe rotavirus gastroenteritis (Vesikari score ≥11) arising 14 days or more after the third dose of placebo or vaccine to end of study (March 31, 2009; around 21 months of age). Analysis was per protocol; infants who received scheduled doses of vaccine or placebo without intervening laboratory-confirmed naturally occurring rotavirus disease earlier than 14 days after the third dose and had complete clinical and laboratory results were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT00362648.
Findings: 2036 infants were randomly assigned to receive pentavalent rotavirus vaccine (n=1018) or placebo (n=1018). 991 infants assigned to pentavalent rotavirus vaccine and 978 assigned to placebo were included in the per-protocol analysis. Median follow up from 14 days after the third dose of placebo or vaccine until final disposition was 498 days (IQR 480—575). 38 cases of severe rotavirus gastroenteritis (Vesikari score ≥11) were reported during more than 1197 person-years of follow up in the vaccine group, compared with 71 cases in more than 1156 person years in the placebo group, resulting in a vaccine efficacy of 48·3% (95% CI 22·3—66·1) against severe disease (p=0·0005 for efficacy >0%) during nearly 2 years of follow-up. 25 (2·5%) of 1017 infants assigned to receive vaccine and 20 (2·0%) of 1018 assigned to receive placebo had a serious adverse event within 14 days of any dose. The most frequent serious adverse event was pneumonia (vaccine 12 [1·2%]; placebo 15 [1·5%]).
Interpretation: In infants in developing countries in Asia, pentavalent rotavirus vaccine is safe and efficacious against severe rotavirus gastroenteritis, and our results support expanded WHO recommendations to promote its global use.
Funding: PATH (GAVI Alliance grant) and Merck.
Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial
The Lancet, Volume 376, Issue 9741, Pages 615 - 623, 21 August 2010
K Zaman PhD, Dang Duc Anh PhD, Dr John C Victor PhD Corresponding AuthorEmail Address, Sunheang Shin MS, Md Yunus MBBS , Michael J Dallas PhD, Goutam Podder MBBS, Vu Dinh Thiem MD, Le Thi Phuong Mai MD, Stephen P Luby MD, Le Huu Tho MD f, Michele L Coia BS, Kristen Lewis MPH, Stephen B Rivers MBA, Prof David A Sack MD, Florian Schödel MD, A Duncan Steele PhD, Kathleen M Neuzil MD, Max Ciarlet PhD
OBJECTIVE. Our goal was to predict, using delayed diphtheria-tetanus-acellular pertussis vaccination as an indicator, whether the current narrowly defined age limits for pentavalent rotavirus vaccine exclude a substantial proportion of children from complete immunization against rotavirus and to assess adherence of providers to recommended age limits by examining the first 6 months of use of pentavalent rotavirus vaccine in Philadelphia, Pennsylvania. PATIENTS AND METHODS. Data from a computerized children's immunization registry in Philadelphia were analyzed. Demographics and age at immunization with first 3 diphtheria-tetanus-acellular pertussis doses were examined from 2001 to 2005. Similar characteristics were evaluated for children who received pentavalent rotavirus vaccine doses during the first 6 months of its availability (August 2006 through January 2007). RESULTS. During the 5-year period, 24 403 of 103 967 recipients of first diphtheria-tetanus-acellular pertussis vaccine were >12 weeks of age; only 56 411 of 79 564 first diphtheria-tetanus-acellular pertussis recipients ≤12 weeks of age received the first 3 doses at ages that they could have completed the pentavalent rotavirus vaccine series if vaccines were given at the same visit. Children using public providers were more likely to have delayed immunization. During the first 6 months of pentavalent rotavirus vaccine implementation, 5566 pentavalent rotavirus vaccine doses were recorded in the Kids Immunization Database/Tracking System: 3912 first doses, 1419 second doses, and 235 third doses. Of 3912 first-dose pentavalent rotavirus vaccine recipients, 770 were >12 weeks of age. Hospital-based providers were less likely to administer pentavalent rotavirus vaccine off-label. CONCLUSIONS. With the current level of vaccine implementation and current pentavalent rotavirus vaccine recommendations for series initiation, a substantial proportion of children are expected to be excluded from receiving any pentavalent rotavirus vaccine or completing the series. In the first 6 months of availability, pentavalent rotavirus vaccine frequently was used off-label for age, underscoring the importance of education of immunization providers. Current outreach programs for finding 10-month-old toddlers delinquent for immunizations will not improve the possibility of protection against rotavirus.
Implementation of Rotavirus Immunization in Philadelphia, Pennsylvania: High Levels of Vaccine Ineligibility and Off-Label Use
PEDIATRICS Vol. 122 No. 1 July 2008, pp. e33-e38 (doi:10.1542/peds.2007-2464)
Nel mese di settembre l’ACP ha organizzato a Roma, presso la Sala Cenacolo della Camera, una giornata di lavoro sulle vaccinazioni per riprendere il confronto con tutti i soggetti coinvolti in un’analoga iniziativa nel 2003. Il documento offerto alla discussione comune - “8 passi di prevenzione a tutela della salute dei bambini” (vedi documento pubblicato a pag. 643) - è stato commentato da: Ministero, Istituto Superiore di Sanità, Regioni, Società scientifiche (di Pediatria e di Medicina preventiva), Sindacati della pediatria di libera scelta, pediatri di comunità, ASL, medici della prevenzione, associazioni di cittadini e UNICEF.
8 passi dell'ACP per un cammino condiviso
Editoriale - Medico e Bambino 2006;25(10):619-622
8 passi di prevenzione a tutela
della salute dei bambini.
Le proposte dell’ACP per una politica vaccinale nazionale
Documenti - Medico e Bambino 2006;25(10):643-646
Riportiamo tre importanti contributi sulla influenza aviaria
e sulla vaccinazione anti-influenzale, di estrema chiarezza e semplicità.
Sia l'Associazione Culturale Pediatri che la Società Italiana
di Pediatria ci dicono che la vaccinazione antiinflunezale non ha nulla
a che vedere che vedere con l'influenza aviaria e che la vaccinazione
in primis alle categorie a rischio di bambini che sono i bambini con gravi patologie croniche.
necessario vaccinare tutti i bambini sani per l'influenza? No.
di D. Faraguna
Vaccinazione antinfluenzale: il parere della Società Italiana di Infettivologia Pediatrica
a cura della Società Italiana di Infettivologia Pediatrica
Influenza aviaria: proviamo a fare chiarezza di L. Grandori
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