Risk of Immune Thrombocytopenic Purpura After Measles-Mumps-Rubella Immunization in Children
Department of Preventive Medicine, Kaiser Pemanente Colorado, Denver, CO 80231, USA. PEDIATRICS
(Impact Factor: 5.47).
03/2008; 121(3):e687-92. DOI: 10.1542/peds.2007-1578
The measles-mumps-rubella vaccine has been associated with immune thrombocytopenia purpura in 2 small studies.
By using the Vaccine Safety Datalink, we identified measles-mumps-rubella-vaccinated children aged 1 to 18. A case of immune thrombocytopenia purpura was defined as a patient with a platelet count of < or = 50,000/microL with clinical bleeding and normal red and white blood cell indices. The immune thrombocytopenia purpura incidence rates during exposed (42 days after vaccination) and unexposed time periods were determined. A retrospective cohort of vaccinated children was used to determine incident rate ratios for children aged 1 to 18 years, 12 to 23 months, and 12 to 15 months.
A total of 1,036,689 children received 1,107,814 measles-mumps-rubella vaccinations; there were 259 confirmed patients with immune thrombocytopenia purpura. Because only 5 exposed cases occurred after age 2, analyses were limited to children aged 12 to 23 months. Exposed patients aged 12 to 23 months had lower median platelet counts than those who were unexposed and had similar median duration of illness (11 vs 10 days). The incident rate ratio was highest for children aged 12 to 15 months at 7.10. The incident rate ratio for boys aged 12 to 15 months was 14.59, and the incident rate ratio for girls in the same age group was 3.22. Seventy-six percent of immune thrombocytopenia purpura cases in children aged 12 to 23 months were attributable to measles-mumps-rubella vaccination. This vaccine causes 1 case of immune thrombocytopenia purpura per every 40,000 doses.
Measles-mumps-rubella vaccine that is given in the second year of life is associated with an increased risk of immune thrombocytopenia purpura.
Available from: PubMed Central
- "Once established, the size of the VSD network enabled CDC and HMO researchers to undertake a series of seminal research projects that evaluated the risk of new (and existing) vaccines, and it also allowed researchers the ability to quickly respond to new concerns about vaccine safety. Such studies conducted by the VSD included ones that outlined the risk of seizures following whole-cell pertussis or measles-mumps-rubella vaccine, found a lack of association between thimerosal containing vaccines and risk for poor neurodevelopment or for autism and analyzed the risk for idiopathic thrombocytopenic purpura ITP after measles, mumps and rubella (MMR) vaccination [9,10,11,12]. "
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ABSTRACT: Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an "industrialized process" approach and (vi) political safe harbor.
Available from: So-ichi Suenobu
- "Thrombocytopenia is common in many infectious processes , especially in association with infectious mononucleosis, cytomegalovirus infection, rubella, measles, Gram-negative bacteria , and rickettsial diseases. The combined live vaccines such as the measles-mumps-rubella (MMR) and MR vaccines   may have an increased risk for inducing ITP, especially in early infancy . "
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ABSTRACT: A 15-month-old infant presented with thrombocytopenic purpura after sequential administration of measles-rubella combined vaccine, varicella vaccine and mumps vaccine every 4 weeks. Her thrombocytopenia persisted for more than 12 months. Both anti-measles and anti-rubella virus IgG antibodies were detected in the patient's-isolated platelets on day 154 of illness, which were not detected when there was a reduction of the serum IgG antibody titers on days 298 and 373 of illness, respectively.We also detected the isolated platelet-binding anti-measles and anti-rubella virus IgG antibodies in two other pediatric patients. This is the first report demonstrating direct evidence of vaccine-induced thrombocytopenic purpura.
Available from: Immanuel Barth
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ABSTRACT: Schutzimpfungen sind eine der effektivsten Maßnahmen zur primären Prävention von Infektionskrankheiten. Fortschritte bei der
Entwicklung, Herstellung und Kontrolle tragen zur zunehmenden Sicherheit und Verträglichkeit von Impfstoffen bei. Aber auch
moderne Impfstoffe sind nicht vollständig frei von Nebenwirkungen. Solche Nebenwirkungen beziehungsweise Impfkomplikationen
müssen kontinuierlich erkannt, verstanden, bewertet und, soweit möglich, verhütet beziehungsweise in ihrer Häufigkeit und
Schwere reduziert werden. Mit diesen Aktivitäten beschäftigt sich die Pharmakovigilanz (Arzneimittelsicherheit) sowohl vor,
während als auch nach der Zulassung der Arzneimittel, um deren fortwährende Sicherheit zu gewährleisten. Die klinische Prüfung
von Impfstoffen ist eine Voraussetzung für ihre Zulassung. Trotz intensiver Forschung ist zum Zeitpunkt der Zulassung eines
Impfstoffes die klinische Erfahrung jedoch begrenzt. Zumeist liegen Daten über wenige Tausend bis Zehntausend Impflinge vor.
In der Regel können damit unerwünschte Ereignisse im Bereich von bis zu 1/1000, maximal von 1/10.000 bis 1/20.000 detektiert
werden. Seltenere Nebenwirkungen und Langzeiteffekte werden daher zumeist erst nach der Zulassung erkannt. Ein passives Surveillance-System
zum frühzeitigen Erkennen von Risikosignalen nach der Zulassung ist das sogenannte Spontanerfassungssystem. Hier werden spontane
Verdachtsmeldungen an das Paul-Ehrlich-Institut gemeldet, dort registriert, bewertet und – falls erforderlich – Maßnahmen
zur Risikoabwehr und Risikovorsorge eingeleitet. Aus dem Spontanerfassungssystem können jedoch keine Nebenwirkungshäufigkeiten
sondern lediglich Signale ermittelt beziehungsweise detektiert werden. Auch ist es schwer, eine Kausalität zu belegen. Um
Kausalität und Häufigkeiten von Impfkomplikationen zu ermitteln, sind andere Instrumente (zum Beispiel klinische Studien,
epidemiologische Untersuchungen) erforderlich. Im vorliegenden Beitrag wird der wissenschaftliche Kenntnisstand zur Kausalität
und Häufigkeit einzelner Nebenwirkungen und hypothetischer Risiken zusammengefasst.
Vaccinations rank among the most effective preventive measures for protection against infectious diseases. Advances in development,
production, and control of vaccines facilitate the increasing standards of vaccine safety and tolerance. Comprehensive pre-clinical
and clinical tests as well as modern manufacturing and testing methods ensure that vaccines marketed nowadays are safe. As
a rule, clinical trials performed before granting the marketing authorisation identify the most frequent adverse events and
these results are used to evaluate the safety of the product. Such trials can identify relatively rare adverse events, which
occur with a frequency of 1:1,000 to 1:10,000 of all vaccinated individuals. These adverse events will then be included in
the summary of product characteristics (SPC) for the vaccine. Even after comprehensive clinical trials of vaccines, it is
possible that very rare adverse events may be observed for the first time during general use of a vaccine. In recent years
concern over real and alleged risks of vaccines relative to their benefit has grown in many countries including Germany. One
reason for this is the fact that most infections that were previously feared have now faded from memory. This situation can
be ascribed in part to the success of vaccination. In recent years an increased awareness of substantiated and assumed risks
following immunization has been reported in Germany as well as many other countries. In part this may be due to the absence
of infectious disease-related mortality and morbidity and to the fact that the severity of vaccine-preventable diseases is
no longer observable. Consequently, rare and hypothetical adverse events attain undue public attention. As vaccination willingness
diminishes, a resulting lower vaccination rate renders the population susceptible to the natural wild type infection with
concomitant increases in mortality and morbidity of vaccine-preventable diseases. Thus, very rare or even unproven adverse
events have attracted public attention. Declining vaccination rates resulting from these fears may result in a renewed increase
of vaccine-preventable diseases. Adverse events following immunization (AEFI) need to be recognized and adequately assessed.
This review presents the scientific knowledge concerning causality and frequency of several AEFI and hypothetical risks.
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