Unintended events following immunization with MMR: a
systematic review.
Jefferson T, Price D, Demicheli V, Bianco E; European Research Program for
Improved Vaccine Safety Surveillance (EUSAFEVAC) Project.
Reparto Epidemiologia Clinica, Istituto Superiore di Sanita, Viale Regina
Elena, 299-00161 Rome, Italy. toj1@aol.com
Public debate over the safety of the trivalent measles, mumps and rubella
(MMR) vaccine and the drop in vaccination rates in several countries persists
despite its almost universal use and accepted effectiveness. We carried out a
systematic review to assess the evidence of unintended effects (beneficial or
harmful) associated with MMR and the applicability of systematic reviewing
methods to the field of safety evaluation. Eligible studies were comparative
prospective or retrospective on healthy individuals up to 15 years of age,
carried out or published by 2003. We identified 120 articles satisfying our
inclusion criteria and included 22.
MMR is associated with a lower incidence of upper respiratory tract
infections, a higher incidence of irritability, similar incidence of other
adverse effects compared to placebo and is
likely to be associated with benign
thrombocytopenic purpura
(TP),
parotitis,
joint and limb complaints and aseptic meningitis (mumps Urabe
strain-containing MMR). Exposure to MMR is unlikely to be associated
with Crohn's disease, ulcerative colitis, autism or aseptic meningitis (mumps
Jeryl-Lynn strain-containing MMR). The design and reporting of safety outcomes
in MMR vaccine studies, both pre- and post-marketing, are largely inadequate.
The evidence of adverse events following immunization with MMR cannot be
separated from its role in preventing the target diseases.
MMR vaccine and idiopathic thrombocytopaenic purpura.
Black C, Kaye JA, Jick H.
Department of Public Health, Aberdeen University, Aberdeen, UK. corri.black@abdn.ac.uk
AIMS: To estimate the relationship between idiopathic thrombocytopaenic
purpura (ITP) and the measles, mumps and rubella (MMR) vaccination in
children; calculating the relative risk estimate for ITP with in 6 weeks after
MMR vaccination and the attributable risk of ITP within 6 weeks after MMR
vaccination. METHODS: Using the General Practice Research Database we
identified children with a first-time diagnosis of ITP from a base population
of children aged less than 6 years between January 1988 and December 1999.
After describing the characteristics of all the children identified with ITP,
we focused on cases aged 13-24 months to perform a population-based,
case-control analysis to estimate the relative risk of developing ITP within 6
weeks after MMR vaccination. We also calculated the risk of ITP attributable
to the MMR vaccination. RESULTS: Sixty-three children with a first time
diagnosis of ITP were identified; 23 cases were between 13 and 24 months old.
The relative risk estimate for ITP within 6 weeks after MMR vaccination,
compared to the combined group of unvaccinated children and children
vaccinated with MMR more than 26 weeks previously was 6.3 (95% CI 1.3-30.1).
The attributable risk of developing ITP within 6 weeks after MMR vaccination
was estimated to be 1 in 25,000 vaccinations (95% confidence interval 21,300,
89,400). CONCLUSION: This study
confirms the increased risk of
ITP within 6 weeks after MMR
vaccination. However, the attributable risk of ITP
within 6 weeks after MMR vaccination is low.
Immune thrombocytopenic purpura in childhood: a Lebanese
perspective.
Moussalem M, Yassine N.
Pediatric Hematology-Oncology Division, Saint Georges Hospital affiliated with
Balamand University, Beirut, Lebanon. mirnamou@inco.com.lb
Immune thrombocytopenic purpura (ITP), due to the production of antiplatelet
antibodies, is the most prevalent etiology of thrombocytopenia in children and
a frequent cause of consultation for the pediatrician. We review here a series
of Lebanese pediatric patients presenting with ITP and we discuss the relevant
characteristics of the group. STUDY: A retrospective chart analysis was
performed for 40 hospitalized or out-patient children presenting with ITP
between January 1998 and December 2001. All cases except two had a diagnosis
confirmed by bone marrow aspirate. Patients were equally distributed between
the sexes with a mean age of 56 months. More than half of the patients had an
episode of fever 2 days to 8 weeks prior to the diagnosis. For 42% of them,
the disease appeared in the months between January and March. Ten percent
presented with epistaxis but all of these had a platelet count less than
12,000. One-third of the patients had received immunization 2-8 weeks before
the diagnosis, with one patient having a relapse 4 weeks after
mumps-measles-rubella (MMR) immunization, which was 1 year after the initial
cure. Initial treatment consisted of either steroids or intravenous polyvalent
immunoglobulin in 58 and 36% of the cases, respectively. None of the patients
had life-threatening hemorrhage. Only 10% of the patients developed chronic
ITP (unremitting after 6 months). CONCLUSION: ITP is generally a benign
disease in infancy and childhood. Certain characteristics of ITP in this
series, such as the seasonal variation and the post-vaccine ITP, will need to
be better defined in larger prospective studies. Optimal treatment will
eventually be targeted towards a better delineation of the disease phenotype.
Idiopathic thrombocytopenic purpura and MMR vaccine.
Miller E, Waight P, Farrington CP, Andrews N, Stowe J, Taylor B.
Immunisation Division, Public Health Laboratory Service Communicable Disease
Surveillance Centre, Colindale, London NW9 5EQ, UK. e.miller@phls.co.uk
A CAUSAL ASSOCIATION BETWEEN MEASLES:
mumps-rubella (MMR) vaccine and idiopathic thrombocytopenic purpura
(ITP)
was confirmed using
immunisation/hospital admission
record linkage. The absolute risk within six weeks of immunisation
was 1 in 22 300 doses, with two of every three cases occurring in the six week
post-immunisation
period being caused by MMR. Children with ITP
before MMR had no vaccine associated recurrences.
[Thrombocytopenic purpura after isolated or combined
vaccination against measles, mumps and rubella]
[Article in French]
Autret E, Jonville-Bera AP, Galy-Eyraud C, Hessel L.
Service de Pharmacologie Clinique, Hopital Bretonneau, Tours, France.
A retrospective epidemiological survey was conducted to evaluate the incidence
and characteristics of thrombocytopenic purpura (TP) reported in France
following measles, mumps or rubella vaccination with monovalent or multivalent
vaccines. Sixty cases of TP were reported i.e an incidence/100,000 doses of
0.23 and 0.17 for measles or rubella vaccines respectively given alone, to
0.87 for combined measles-rubella vaccine and 0.95 for MMR vaccine. The mean
age was 21 +/- 12 months and the delay of diagnosis was 16 +/- 6 days after
vaccination. Thrombopenia was severe (mean platelet count: 8000 +/- 6000/mm3)
and always associated with purpura. The immediate outcome was favourable in
89.5 per cent of cases.
Vaccine-associated TP
appears to be similar to acute childhood idiopathic thrombocytopenic purpura
but the clear temporal relationship between MMR vaccination and the occurrence
of TP
make a causal relationship highly plausible. Acute TP seems a rare
complication of measles-rubella and MMR vaccination but clinicians had to be
informed of the possibility of their occurrence. Acute TP following
vaccination should be reported by physicians to their Regional Drug
Surveillance Centre.
A new method for active surveillance of adverse events from
diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines.
Farrington P, Pugh S, Colville A, Flower A, Nash J, Morgan-Capner P, Rush
M, Miller E.
Public Health Laboratory Service Statistics Unit, Communicable Disease
Surveillance Center, London, UK.
We describe a new method for active post-marketing surveillance of vaccine
safety based on patient records. We studied the association between
diphtheria/tetanus/pertussis (DTP) vaccination and febrile convulsion, and
between measles/mumps/rubella (MMR) vaccination and febrile convulsion and
idiopathic thrombocytopenic purpura (ITP) in five district health authorities
in England by linking vaccination records with computerised hospital admission
records. We found an increased relative incidence for convulsions 0-3 days
after DTP vaccination. The effect was limited to the third dose of vaccine for
which the attributable risk (all ages) was 1 in 12,500 doses. Completion of
vaccination by 4 months instead of 10 months after the change in the UK to an
accelerated immunisation schedule may have resulted in a 4-fold decrease in
febrile convulsions attributable to DTP vaccine. 67% of admissions for a
convulsion 6-11 days after MMR vaccination were attributable to the measles
component of the vaccine (risk 1 in 3000 doses). An excess of admissions for a
convulsion 15-35 days after MMR vaccination was found only for vaccines
containing the Urabe mumps strain (1 in 2600 Urabe doses).
There was a causal association between
MMR vaccination and ITP
resulting in admission 15-35 days subsequently; there was no evidence of a
mumps strain-specific effect. The estimated absolute risk of 1 in 24,000 doses
was 5 times that calculated from cases passively reported by clinicians. This
finding emphasises
the need for active surveillance of adverse events. The record linkage
method that we used is an effective way to identify vaccine-attributable
adverse events.
Acute thrombocytopenic purpura following measles, mumps and
rubella vaccination. A report on 23 patients.
Nieminen U, Peltola H, Syrjala MT, Makipernaa A, Kekomaki R.
Finnish Red Cross Blood Transfusion Service, Helsinki.
An acute thrombocytopenic purpura
developed shortly after measles-mumps-rubella vaccination in 23 of
approximately 700,000 children immunized over a period of seven years.
The mean interval from inoculation to the onset of purpura was 19 days. Bone
marrow aspirates obtained from 13 patients showed increased or normal amounts
of megakaryocytes. Platelet survival time was markedly shortened in the two
patients studied. Fifteen patients recovered (the platelet count exceeded 100
x 10(9)/l) in one month, five in two months and two in six months. Increase in
platelet-associated immunoglobulin was detected in 10 of 15 patients.
Circulating antiplatelet autoantibodies (AAb) against glycoprotein IIb/IIIa
were detected in 5 of 15 patients. The findings are compatible with an
autoimmune mechanism triggered by immune response to measles-mumps-rubella
vaccination. As evaluated by the clinical course and the presence of AAb,
post-vaccination thrombocytopenic purpura appears to be indistinguishable from
childhood acute idiopathic thrombocytopenic purpura.
PMID: 8495082 [PubMed - indexed for MEDLINE]
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