Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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4 Measles, Mumps, and Rubella Vaccine
4 Measles, Mumps, and Rubella Vaccine
Pages 103-238
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From page 103... ...
. The incubation period of the measles virus is 10 to 12 days (CDC, 1998)
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From page 104... ...
. In 1965 and 1968, the Schwarz and Moraten (more attenuated strain derived from Ender's attenuated Edmonston measles virus)
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. Hearing loss due to infection of the endolymph is also a potential complication of mumps infection (Tanaka et al., 1988)
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From page 106... ...
. In the United States, mumps vaccines are manufactured using the Jeryl Lynn strain mumps virus that was isolated from the throat of Jeryl Lynn Hilleman in the 1960s (Plotkin and Rubin, 2008)
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From page 107... ...
Although Merck is licensed to produce monovalent measles, mumps, and rubella vaccines -- Attenuvax, Meruvax, and Mumpsvax, respectively -- currently, these vaccines are no longer available in the United States. The combination vaccine, M-M-R II (Merck)
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From page 108... ...
. ProQuad contains greater than 3.0 log10 TCID50 of a more attenuated line of measles virus derived from Ender's attenuated Edmonston strain, greater than 4.3 log10 TCID50 of Jeryl Lynn mumps virus, greater than 3.0 log10 TCID50 of Wistar Institute RA 27/3 rubella virus, and greater than 3.99 log10 plaque-forming units (PFUs)
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From page 109... ...
, presenting with generalized convulsive seizures lasting 40 minutes 9 months after receiving a measles, mumps, and rubella vaccine. Despite treatment the patient continued to develop partial and generalized seizures.
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From page 110... ...
The committee assesses the mechanistic evidence regarding an as sociation between the measles vaccine and measles inclusion body encephalitis in individuals with demonstrated immunodeficiencies as strong based on one case presenting definitive clinical evidence. The committee assesses the mechanistic evidence regarding an as sociation between the mumps or rubella vaccine and measles inclu sion body encephalitis as lacking.
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From page 111... ...
. The authors concluded that MMR vaccination does not increase the risk of encephalitis in children.
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From page 112... ...
The authors concluded that MMR vaccination is not associated with an increased risk of encephalopathy owing to the absence of a consistent time association between vaccination and encephalopathy onset.
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From page 113... ...
Weight of Epidemiologic Evidence Two of the three studies detailed above showed no significant increased risk of encephalopathy after MMR vaccination. Makela et al.
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From page 114... ...
identified in 11/1982 to encephalitis Risk period: 199 children the nationwide 6/1986 within 3 0–3 months hospitalized hospital months after MMR for encephalitis discharge of MMR vaccination register Nine vaccination Control period: encephalitis (p = .28) Subsequent events occurred 3-month within 3 intervals months after the risk of MMR period until 24 vaccination months was reached Ray et al.
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From page 115... ...
and 9/2001 disease vaccination: 6–11 days after MMR obtained 5.68 (95% CI, of MMR vaccination Six events from monthly 2.31–13.97) vaccination occurred surveillance Control reported within 6–11 RR of severe surveys to period: all complex days of neurologic pediatricians time observed febrile seizures vaccination disease within outside the risk combined with 15–35 days period Five events encephalopathy of MMR occurred vaccination: within 1.34 (95% CI, 15–35 days of 0.52–3.47)
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From page 116... ...
(1987) described a 7-year-old girl presenting with vomiting, headache, twitching of upper extremities, followed by coma lasting for several hours 54 days after receiving a measles, mumps, and rubella vaccine containing the Moraten measles strain and 5.5 years after receiving a
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From page 117... ...
Measles virus was demonstrated in the CSF again. Weight of Mechanistic Evidence Encephalitis is considered a complication of infection with wild-type measles, mumps, and rubella viruses (Gershon, 2010a,b; Litman and Baum, 2010)
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From page 118... ...
(1987) reported the isolation of measles virus, on two occasions, from the CSF in a patient that developed symptoms of encephalopathy after administration of measles, mumps, and rubella vaccines.
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From page 119... ...
FEBRILE SEIZURES Epidemiologic Evidence The committee reviewed 19 studies to evaluate the risk of febrile seizures after the administration of vaccines containing measles, mumps, and rubella alone or in combination. Nine studies (Al Awaidy et al., 2010; Bino et al., 2003; D'Souza et al., 2000; Fescharek et al., 1990; Landrigan and Witte, 1973; Miller, 1982; Patja et al., 2000; Stetler et al., 1985; Vahdani et al., 2005)
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From page 120... ...
The control period was defined as any time not included in the risk period. The relative risk of febrile seizures within 6–11 days of MMR vaccination including the Jeryl Lynn mumps strain was 3.77 (95% CI, 1.95–7.30)
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From page 121... ...
. The authors found a significantly increased risk of febrile seizures within 6 to 11 days of MMR vaccination.
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From page 122... ...
. The authors concluded that MMR vaccination is associated with a significantly increased risk of febrile seizures within 2 weeks of vaccine administration.
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From page 123... ...
The authors found a significant increased risk of seizures in the 1-year age group within 6 to 11 days of MMR vaccination. However, the study included two vaccine formulations, one of which is not available in the United States, and the association of these vaccines with febrile seizures was not analyzed separately.
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From page 124... ...
The committee has a high degree of confidence in the epidemio logic evidence based on seven studies with validity and precision to assess an association between MMR vaccine and febrile seizures; these studies consistently report an increased risk. Mechanistic Evidence The committee identified 15 publications reporting febrile seizures developing after the administration of vaccines containing measles, mumps, and rubella alone or in combination.
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From page 125... ...
after MMR computerized between seizures vaccination RR of febrile seizures hospital 10/1988 within 15–35 days of records and 2/1993 Control MMR vaccination: period: all 1.04 (95% CI, time not 0.56–1.93) included in the risk period 125 continued
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From page 126... ...
and 15–30 seizures obtained in days after occurred Adjusted RR of the HMO MMR within febrile seizures within data systems vaccination 30 days 8–14 days of MMR of MMR vaccination: vaccination 2.83 (95% CI, 1.44–5.55) Adjusted RR of febrile seizures within 15–30 days of MMR vaccination: 0.97 (95% CI, 0.49–1.95)
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From page 127... ...
vaccination Adjusted RR of febrile seizures within the combined 2 weeks following MMR vaccination: 2.75 (95% CI, 2.32–3.26) 127 continued
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From page 128... ...
seizures London and 17 years in 1-year within 6–11 days of 6 to 11 days Risk periods: South East diagnosed age group MMR vaccination: of MMR 6–11 days and region of with experienced 2.07 (95% CI, vaccination 15–35 days the United seizures a total of 1.00–4.27) after MMR Kingdom from 367 seizures vaccination RR of seizures in 11/1/1999 (326 febrile the 1-year age group through Control seizures and within 15–35 days of 9/30/2003 period: 41 other or MMR vaccination: all time not unspecified 0.65 (95% CI, included in the seizures)
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From page 129... ...
admissions and South months case series children within 6–11 days of described for febrile Thames diagnosed were MMR vaccination: Risk periods: convulsions region of with hospitalized 4.27 (95% CI, 6–11 days and (includes the United seizures with 988 3.17–5.76) 15–35 days all National Kingdom from seizure after MMR RR of febrile seizures Health 1/1/1998 episodes vaccination within 15–35 days of Service through 52 febrile MMR vaccination: hospitals)
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From page 130... ...
Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence.
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From page 131... ...
presented with a febrile seizure, exanthem, meningismus, and right side hemiparesis 10 days after receiving a measles, mumps, and rubella vaccine.
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From page 132... ...
In addition, the four publications described above presented clinical evidence sufficient for the committee to conclude the vaccine may be a contributing cause of febrile seizures after administration of MMR vaccine. The publications presented a symptomology of fever with seizure developing within the incubation phases for measles and mumps viruses.
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From page 133... ...
(1991) was described in detail in the section on febrile seizures following MMR vaccination.
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From page 134... ...
Weight of Epidemiologic Evidence Two large studies (Barlow et al., 2001; Davis et al., 1997) failed to identify enough cases to adequately address whether MMR vaccination is associated with an increased risk of afebrile seizures.
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From page 135... ...
confirmed and NCK years and cohort children No chart-confirmed described clinic, HMOs from 10–12 ages 10–12 visits for seizure Risk period: emergency 3/1991 years years diagnoses 1 month department, through after MMR 8,514 10- to 12-year-olds: and hospital 12/1994 vaccination children Three seizures visits for ages 4–6 diagnoses during the seizures Control years risk period compared period: Began to none during the 3 months control period before MMR vaccination and ended 2 months before vaccination 135 continued
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From page 136... ...
of afebrile in the with within 8–14 days of Risk periods: seizures VSD from afebrile MMR vaccination: 0–7 days, 8–14 from medical 1991–1993 seizures 1.11 (95% CI, days, and records 0.11–11.28) 15–30 days Three obtained in after MMR afebrile Adjusted RR of the HMO data vaccination seizures afebrile seizures systems occurred within 15–30 days of Seizures among within MMR vaccination: children with 30 days 0.48 (95% CI, diagnoses of of MMR 0.05–4.64)
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From page 137... ...
Weight of Mechanistic Evidence The committee assesses the mechanistic evidence regarding an as sociation between MMR vaccine and afebrile seizures as lacking. Causality Conclusion Conclusion 4.5: The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and afebrile seizures.
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From page 138... ...
This retrospective cohort study investigated the occurrence of aseptic meningitis following MMR vaccination in children (1 to 7 years of age) in Finland.
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From page 139... ...
. The authors concluded that MMR vaccination with Jeryl Lynn or Rubini mumps strain does not appear to be associated with an increased risk of aseptic meningitis in children.
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From page 140... ...
identified 11/1982 to aseptic meningitis Risk period: 161 children in the 6/1986 within 3 months 0–3 months after hospitalized nationwide of MMR MMR vaccination for meningitis hospital vaccination
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From page 141... ...
c Studies designated as serious had more methodological limitations than those designated as negligible. Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence.
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From page 142... ...
The three publications described above did not present evidence sufficient for the committee to conclude the vaccine may be a contributing cause of meningitis after administration of a vaccine containing measles, mumps, and rubella alone or in combination. The publications reported the isolation of mumps virus from urine, blood, pharyngeal fluid and smears, and CSF, but while one publication reported the isolation of a mumps virus that acted similarly to vaccine strain mumps virus in cell culture studies, no publications definitively reported the isolation of vaccine strain mumps virus.
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From page 143... ...
Mechanistic Evidence The committee identified eight publications reporting ataxia after the administration of vaccines containing measles, mumps, and rubella alone or in combination. Seven publications did not provide evidence beyond temporality (Ehrengut and Zastrow, 1989; Fescharek et al., 1990; MartinonTorres, 1999; Nader and Warren, 1968; Peltola et al., 1998; Plesner et al., 2000; Trump and White, 1967)
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From page 144... ...
The committee assesses the mechanistic evidence regarding an as sociation between measles or mumps vaccine and ataxia as weak based on knowledge about the natural infection and one case. The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and ataxia as lacking.
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From page 145... ...
were not considered in the weight of epidemiologic evidence because they provided data from a passive surveillance system lacking an unvaccinated comparison population or an ecological comparison study lacking individual-level data. Five controlled studies (DeStefano et al., 2004; Richler et al., 2006; Schultz et al., 2008; Taylor et al., 2002; Uchiyama et al., 2007)
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From page 146... ...
The relative risk of autism diagnosis within 12 months of MMR vaccination was 0.94 (95% CI, 0.60–1.47) and within 24 months of MMR vaccination was 1.09 (95% CI, 0.79–1.52)
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From page 147... ...
. The authors concluded that MMR vaccination is not associated with an increased risk of autistic disorder or other autistic-spectrum disorders.
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From page 148... ...
The committee has a high degree of confidence in the epidemiologic evidence based on four studies with validity and precision to assess an association between MMR vaccine and autism; these studies consistently report a null association. Mechanistic Evidence The committee identified four publications reporting autism developing after the administration of MMR vaccine.
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From page 149... ...
c Taylor Autism North East Children Self-controlled 357 children RR of autism RR of parental Negligible et al. diagnosis Thames born from case series with autism diagnosis within 12 concern within (1999)
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From page 150... ...
c Farrington Autism North East Children Self-controlled 357 children RR of autism None Negligible et al. diagnosis Thames born from case series with autism diagnosis within 59 described (2001)
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From page 151... ...
the ICD-10 Registration Denmark after MMR 316 children criteria and System and from vaccination: with autism was obtained five other 1/1/1991 0.92 (95% CI, diagnosis from Danish national through 0.68–1.24) Psychiatric registries 12/31/1998 1,647,504 Adjusted RR of Central person-years of diagnosis of other Register follow-up for autistic spectrum exposed group disorders following 482,360 MMR vaccination: person-years 0.83 (95% CI, of follow-up 0.65–1.07)
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From page 152... ...
criteria and general vaccination: by age, 192 controls was obtained practice 0.17 (95% CI, gender, and from general records 0.06–0.52) physician's practitioner practice Adjusted OR for records autism diagnosis after single-antigen measles or MMR vaccination: 0.28 (95% CI, 0.10–0.76)
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From page 153... ...
Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between MMR vaccine and ADEM. Mechanistic Evidence The committee identified three publications reporting the development of ADEM after the administration of vaccines containing measles, mumps, and rubella alone or in combination.
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From page 154... ...
Mechanistic Evidence The committee identified five publications reporting the development of transverse myelitis after the administration of vaccines containing measles, mumps, and rubella alone or in combination. Two publications did not provide evidence beyond temporality (Cizman et al., 2005; Landrigan and
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From page 155... ...
(2004) described a 9-year-old girl presenting with urinary incontinence 16 days after administration of a measles and rubella vaccine containing the Edmonston-Zagreb measles strain and RA 27/3 rubella strains.
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From page 156... ...
Weight of Epidemiologic Evidence The committee has limited confidence in the epidemiologic evi dence, based on one study that lacked validity and precision to assess an association between MMR vaccine and optic neuritis. Mechanistic Evidence The committee identified three publications reporting optic neuritis developing after the administration of vaccines containing measles, mumps,
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From page 157... ...
Autoantibodies, T cells, immune complexes, direct viral infection, persistent viral infection, and molecular mimicry may contribute to the symptoms of optic neuritis; however, the publications did not provide evidence linking these mechanisms to MMR vaccine. The committee assesses the mechanistic evidence regarding an as sociation between MMR vaccine and optic neuritis as weak based on knowledge about the natural infection and two cases.
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From page 158... ...
Mechanistic Evidence The committee identified one publication reporting the development of NMO after the administration of rubella vaccine. Kline et al.
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From page 159... ...
The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and neuromyelitis optica as weak based on knowledge about the natural infection and one case. The committee assesses the mechanistic evidence regarding an as sociation between measles or mumps vaccine and NMO as lacking.
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From page 160... ...
vaccine strains, as well as Schwarz measles strain found in the monovalent vaccine. The authors concluded that measles, mumps, and rubella vaccinations are not associated with MS onset, and noted that the increased odds ratio observed with early MMR vaccination relative to MMR vaccination given at other ages is considered weak evidence owing to the small number of subjects (only eight subjects in early vaccination group)
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From page 161... ...
The committee has limited confidence in the epidemiologic evi dence, based on two studies that lacked validity and precision to assess an association between MMR vaccine and onset of MS in adults. Mechanistic Evidence The committee identified one publication reporting the onset of MS in adults after the administration of rubella vaccine.
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From page 162... ...
medical Sahlgrenska Sweden, with MS vaccination records and University from compared to no 888 confirmed by Hospital and 1959–1986 MMR vaccination: controls authors the National 1.13 (95% CI, 0.62– Cases had Patient 2.05; p = .6849) MS onset at Register of 10 years of OR of MS onset Sweden age or older with monovalent or combined measles, mumps, and rubella vaccination compared to no
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From page 163... ...
Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence.
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From page 164... ...
vaccine strains, as well as Schwarz measles strain found in the monovalent vaccine. The authors concluded that measles, mumps, and rubella vaccinations are not associated with MS onset, and noted that the increased odds ratio observed with early MMR vaccination relative to MMR vaccination given at other ages is considered weak evidence owing to the small number of subjects (only eight subjects in early vaccination group)
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From page 165... ...
Mechanistic Evidence The committee identified seven publications reporting the development of GBS after the administration of vaccines containing measles, mumps, and rubella alone or in combination. Patja et al.
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From page 166... ...
(2002) did not report relapse in GBS patients after administration of measles, mumps, or rubella vaccines.
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From page 167... ...
Mechanistic Evidence The committee identified one publication reporting the development of OMS after the administration of rubella vaccine. Lapenna et al.
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From page 168... ...
Mechanistic Evidence The committee did not identify literature reporting clinical, diagnostic, or experimental evidence of brachial neuritis developing after the administration of MMR vaccine. Weight of Mechanistic Evidence Autoantibodies, T cells, and complement activation may contribute to the symptoms of brachial neuritis; however, the committee did not identify literature reporting evidence of these mechanisms after administration of MMR vaccine.
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From page 169... ...
Mechanistic Evidence The committee identified 11 publications describing clinical, diagnostic, or experimental evidence of anaphylaxis after the administration of vaccines containing measles, mumps, and rubella alone or in combination that contributed to the weight of mechanistic evidence. These publications are described below.
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From page 170... ...
Case 1 describes a 15-month-old presenting with cyanosis, tachypnea, and angiodema less than 15 minutes after vaccination with the Schwarz-containing measles vaccine. Case 2 describes an 18-month-old presenting with stridor, erythema, and vomiting less than 5 minutes after vaccination with rubella vaccine.
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From page 171... ...
(1993) reported one case of anaphylaxis developing after administration of a measles vaccine containing the Edmonston-Zagreb strain.
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From page 172... ...
Case 1 described an 11-month-old boy, with a history of sensitivity to egg, presenting with generalized urticaria and pruritus after undergoing an intradermal test using a 1:100 dilution of a measles, mumps, and rubella vaccine. Case 2 described a 22-month-old girl, with a history of egg allergy, presenting with dyspnea and wheezing within 30 minutes of undergoing an intradermal test using a 1:100 dilution of a measles, mumps, and rubella vaccine.
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From page 173... ...
Weight of Mechanistic Evidence The publications described above presented clinical and experimental evidence sufficient for the committee to conclude the vaccine was a contributing cause of anaphylaxis after administration of vaccines containing measles, mumps, and rubella alone or in combination. The clinical descriptions provided in many of the publications establish a strong temporal relationship between administration of the vaccine and the anaphylactic reaction.
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From page 174... ...
TRANSIENT ARTHRALGIA IN WOMEN Epidemiologic Evidence The committee reviewed five studies to evaluate the risk of transient arthralgia in women after the administration of rubella vaccine. One controlled study (Polk et al., 1982)
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From page 175... ...
The odds ratio for the frequency of acute arthralgia or arthritis among postpartum women receiving RA 27/3 strain rubella vaccine compared to placebo was 1.73 (95% CI, 1.17–2.57)
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From page 176... ...
The authors concluded that certain DR2 and DR5 alleles may influence the development of acute arthropathy in postpartum women receiving rubella vaccine. Weight of Epidemiologic Evidence Of the four studies described above, Tingle et al.
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From page 177... ...
TABLE 4-7 Studies Included in the Weight of Epidemiologic Evidence for MMR Vaccine and Transient Arthralgia in Women Primary Effect Operationally Size Estimatea Heterogeneous Limitations Defined Study Defined Study (95% CI or p Subgroups at (Negligible Citation Outcome Setting Population Study Design Sample Size value) Higher Riskb or Serious)
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From page 178... ...
TABLE 4-7 Continued 178 Primary Effect Operationally Size Estimatea Heterogeneous Limitations Defined Study Defined Study (95% CI or p Subgroups at (Negligible Citation Outcome Setting Population Study Design Sample Size value) Higher Riskb or Serious)
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From page 179... ...
Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence.
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From page 180... ...
assay who received the RA 27/3 rubella vaccine. The authors reported the development of transient arthralgia in 9 of the 36 seronegative women after vaccination and transient arthritis in 6 of the 36 women.
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From page 181... ...
The committee assesses the mechanistic evidence regarding an asso ciation between rubella vaccine and transient arthralgia in women as intermediate based on clinical evidence and 13 cases. The committee assesses the mechanistic evidence regarding an asso ciation between measles or mumps vaccine and transient arthralgia in women as lacking.
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From page 182... ...
The adjusted odds ratio for arthralgia in the 14- to 18-month age group within 21 days following MMR vaccination was 3.66 (95% CI, 1.74–7.70)
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From page 183... ...
. The authors concluded that MMR vaccination was associated with an increased risk of arthralgia in children, but noted the wide confidence interval.
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From page 184... ...
Before MMR vaccination, 40 flares occurred in 36 patients, which was lower than the 56 flares reported in 50 patients after vaccination. The authors concluded that the risk of active disease was not significantly increased by MMR vaccination; however, they noted the limitations of a retrospective study design, the limited power to detect a significant association, and the likely presence of residual bias in the data set.
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From page 185... ...
The studies consistently report an increased risk of transient arthralgia following MMR vaccination in children, with some limitations. The evidence includes (a)
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From page 186... ...
TABLE 4-8 Studies Included in the Weight of Epidemiologic Evidence for MMR Vaccine and Transient Arthralgia in 186 Children Operationally Primary Effect Size Heterogeneous Limitations Defined Study Defined Study Estimatea (95% CI Subgroups at (Negligible or Citation Outcome Setting Population Study Design Sample Size or p value) Higher Riskb Serious)
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From page 187... ...
Chart- GHC Children aged Retrospective 18,036 10–12-year-olds: None Negligible (1997) confirmed and NCK 4–6 years and cohort children ages 13 visits for joint described clinic, HMOs 10–12 years 10–12 years pain 1 month after Risk period: emergency from MMR vaccination 1 month 8,514 department, 3/1991 after MMR children ages Six visits for joint and hospital through vaccination 4–6 years pain 3 months visits for joint 12/1994 before MMR pain Control vaccination period: began 3 4–6-year-olds: months No visits for joint before MMR pain vaccination and ended 2 months before vaccination 187 continued
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From page 188... ...
self-report Clinic, aged 12–24 crossover children increases in joint described (2006) of joint Wisconsin months, 4–6 problems were Risk period: problems years, and reported in any 4 weeks using diaries 10–12 years of the three age after MMR receiving groups after MMR vaccination care at the vaccination Marshfield Control Clinic period: 2 weeks before MMR vaccination
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From page 189... ...
Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence.
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From page 190... ...
Causality Conclusion Conclusion 4.21: The evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia in children. CHRONIC ARTHRALGIA IN WOMEN Epidemiologic Evidence The committee reviewed two studies to evaluate the risk of chronic arthralgia in women after the administration of rubella vaccine.
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From page 191... ...
The committee has limited confidence in the epidemiologic evi dence, based on two studies that lacked validity and precision to assess an association between rubella vaccine and chronic arthral gia in women. The epidemiologic evidence is insufficient or absent to assess an association between measles or mumps vaccine and chronic ar thralgia in women.
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From page 192... ...
c Studies designated as serious had more methodological limitations than those designated as negligible. Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence.
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From page 193... ...
Case 2 describes a 26-year-old woman presenting with an erythematous maculopapular rash on the trunk and extremities followed by fatigue, myalgia, and arthralgias involving the large joints 4 weeks after receiving a rubella vaccine. Serologic tests were negative for hepatitis B virus, cytomegalovirus, and Borrelia burgdorferi and showed past infections of Epstein-Barr virus and parvovirus.
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From page 194... ...
The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and chronic arthralgia in women as low-intermediate based on clinical evidence in four cases. The committee assesses the mechanistic evidence regarding an asso ciation between measles or mumps vaccine and chronic arthralgia in women as lacking.
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From page 195... ...
This randomized controlled trial reported an odds ratio of 1.58 (95% CI, 1.01–2.45) for the frequency of persistent arthralgia or arthritis among postpartum women receiving rubella vaccine compared to placebo.
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From page 196... ...
The committee has limited confidence in the epidemiologic evi dence, based on two studies that lacked validity and precision to assess an association between rubella vaccine and chronic arthritis in women. The epidemiologic evidence is insufficient or absent to assess an as sociation between measles or mumps vaccine and chronic arthritis in women.
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From page 197... ...
(acute, chronic, Kaiser testing was women vaccinated and traumatic) Permanente performed women were 2,421 identified in Health Plan from 1990 diagnosed with seropositive, inpatient and through 1991 chronic arthritis unvaccinated outpatient during the study Exposed aged-matched records and period group received controls confirmed by a rubella vaccine rheumatologist 924 seronegative, within 1 year unvaccinated following unmatched testing controls Tingle Acute and Participating Postpartum, Double- 268 vaccinated OR of persistent None Negligible et al.
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From page 198... ...
Autoantibodies, T cells, immune complexes, and complement activation may contribute to arthritis as well; however, the publications did not provide evidence linking these mechanisms to MMR vaccine. The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and chronic arthritis in women as low-intermediate based on clinical evidence in five cases.
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From page 199... ...
Mechanistic Evidence The committee identified five publications describing chronic arthropathy in children after the administration of vaccines containing measles, mumps, and rubella alone or in combination. Two publications did not provide evidence beyond temporality (Balfour et al., 1980; Bottiger et al., 1974)
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From page 200... ...
The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and chronic arthropathy in chil dren as weak based on knowledge about the natural infection and two cases. The committee assesses the mechanistic evidence regarding an as sociation between measles or mumps vaccine and chronic arthropa thy in children as lacking.
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From page 201... ...
were not considered in the weight of epidemiologic evidence because they provided data from passive surveillance systems and lacked unvaccinated comparison populations. Two controlled studies (Chen et al., 1991; Pattison et al., 2008)
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From page 202... ...
The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and arthropathy in men as weak based on knowledge about the natural infection. The committee assesses the mechanistic evidence regarding an as sociation between measles or mumps vaccine and arthropathy in men as lacking.
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From page 203... ...
pain identified during dormitories at BU or swelling or with self- 3/1985 MIT 391 unvaccinated joint ache/ administered pain following Exposed group MIT: questionnaires MMR or included students 133 vaccinated measles who received MMR vaccination or measles vaccine on 352 unvaccinated their college campus Pattison Psoriatic United Cases: Psoriatic Case-control 125 patients OR for None Serious et al. arthritis Kingdom arthritis patients with psoriatic psoriatic described (2008)
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From page 204... ...
One study (Fescharek et al., 1990) was not considered in the weight of epidemiologic evidence because it provided data from a passive surveillance system and lacked an unvaccinated comparison population.
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From page 205... ...
. The authors concluded that administration of rubella vaccine does not increase the risk of type 1 diabetes in children.
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From page 206... ...
The vaccination data were verified with records from the National Health System. A larger proportion of the controls were exposed to MMR vaccine and measles vaccine when compared to the cases: MMR vaccination in 8.1 percent of cases and 18.7 percent of controls; measles vaccination in 10.3 percent of cases and 12.9 percent of controls.
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From page 207... ...
The committee has a high degree of confidence in the epidemiologic evidence based on five studies with validity and precision to assess an association between MMR vaccine and type 1 diabetes; these studies consistently report a null association. Mechanistic Evidence The committee identified five publications reporting type 1 diabetes developing after the administration of vaccines containing measles and mumps alone or in combination.
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From page 208... ...
reported to with type 1 any time after Cases were enrolled the Swedish diabetes MMR vaccination: in the Swedish Childhood 0.95 (95% CI, Childhood Diabetes 786 Diabetes 0.71–1.28) Register from controls Register 9/1/1985 through matched on OR for type 8/31/1986 age, sex, 1 diabetes and county diagnosis any Controls were time after measles identified in the vaccination: official Swedish 0.74 (95% CI, population register 0.55–1.00)
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From page 209... ...
diabetes in the VSD 1997, ages 10 with type 1 any time after diagnosis in months to 10 years diabetes MMR vaccination the medical using Model 1: 768 record 1.36 (95% CI, controls 0.70–2.63) matched on sex, date OR for type 1 of birth, diabetes diagnosis HMO, and any time after length of MMR vaccination enrollment using Model 2: in the 1.43 (95% CI, HMO 0.71–2.86)
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From page 210... ...
diagnosis in Italy type 1 diabetes in with type 1 any time after the diabetes the diabetes register diabetes MMR vaccination: register of the Abruzzo 0.382 (95% CI, 272 region from 1990 0.201–0.798) controls to 1996 matched OR for type Controls identified on age and 1 diabetes in the National registration diagnosis any Health System with the time after measles records of Italy same vaccination: family 0.777 (95% CI, pediatrician 0.403–1.498)
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From page 211... ...
HEPATITIS Epidemiologic Evidence No studies were identified in the literature for the committee to evaluate the risk of hepatitis after the administration of MMR vaccine. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between MMR vaccine and hepatitis.
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From page 212... ...
The committee assesses the mechanistic evidence regarding an as sociation between MMR vaccine and hepatitis as weak based on knowledge about the natural infection. Causality Conclusion Conclusion 4.27: The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and hepatitis.
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From page 213... ...
Mechanistic Evidence The committee did not identify literature reporting clinical, diagnostic, or experimental evidence of fibromyalgia after the administration of MMR vaccine. Weight of Mechanistic Evidence The committee assesses the mechanistic evidence regarding an as sociation between MMR vaccine and fibromyalgia as lacking.
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From page 214... ...
Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between MMR vaccine and hearing loss. Mechanistic Evidence The committee identified 11 publications reporting hearing loss after the administration of vaccines containing measles, mumps, and rubella alone or in combination.
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From page 215... ...
Case 3 (number 8 in the report) describes a 1.5-year-old girl presenting with fever and exanthem subitum 2 weeks after administration of a measles, mumps, and rubella vaccine.
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From page 216... ...
. Similarly, infection with wild-type measles virus has been associated with bilateral sensorineural hearing loss in 5–10 percent of measles cases (McKenna, 1997)
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From page 217... ...
The committee assesses the mechanistic evidence regarding an as sociation between rubella vaccine and hearing loss as lacking. Causality Conclusion Conclusion 4.30: The evidence is inadequate to accept or reject a causal relationship between MMR vaccine and hearing loss.
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From page 218... ...
7 Intermediate 12 Convincingly Supports MMR Afebrile Seizures Limited 2 Lacking None Inadequate MMR Meningitisb Moderate (null) 3 Weak 4 Inadequate (mumps)
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From page 219... ...
MMR Multiple Sclerosis Onset Limited 2 Lacking None Inadequate in Adults MMR Multiple Sclerosis Onset in Limited 1 Lacking None Inadequate Children MMR Guillain-Barré Syndrome Insufficient None Weak None Inadequate MMR Chronic Inflammatory Insufficient None Lacking None Inadequate Disseminated Polyneuropathy MMR Opsoclonus Myoclonus Insufficient None Lacking None Inadequate Syndrome MMR Brachial Neuritis Insufficient None Lacking None Inadequate MMR Anaphylaxis Insufficient None Strong 43c Convincingly Supports MMR Transient Arthralgia in Moderate (increase) 4 Intermediate 13 Favors Acceptanced Women (rubella)
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From page 220... ...
(measles or mumps) MMR Chronic Arthritis in Limited 2 Low-Intermediate 5 Inadequate Women (rubella)
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From page 221... ...
c Some cases were from passive surveillance systems; however, it was not possible to know how many represented unique cases or were reported elsewhere. d The committee attributes causation to the rubella component of the vaccine.
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From page 222... ...
1980. RA27/3 rubella vaccine.
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From page 223... ...
2005. Safety and immunogenicity of concomitant versus nonconcomitant administration of hepatitis B, tetanus-diphtheria, and measles-mumps-rubella vaccines in healthy eleven to twelve-year-olds.
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From page 224... ...
2004. No evidence for links between autism, MMR and measles virus.
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From page 225... ...
1995. A new method for active surveillance of adverse events from diphtheria/ tetanus/pertussis and measles/mumps/rubella vaccines.
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From page 226... ...
2001. Rubella vaccine and arthritic adverse reactions: An analy sis of the vaccine adverse events reporting system (VAERS)
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From page 227... ...
diabetic children and a plateau in the rising incidence of type 1 diabetes after introduction of the mumps measles-rubella vaccine in finland. Diabetologia 36(12)
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From page 228... ...
1993. Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gelatin.
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From page 229... ...
2006. Evaluation of potentially common adverse events associated with the first and second doses of measles-mumps rubella vaccine.
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From page 230... ...
1993. Chronic rubella vaccine-associated arthropathy.
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From page 231... ...
1986. Frequency of true adverse reactions to measles-mumps rubella vaccine.
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From page 232... ...
1982. A controlled comparison of joint reactions among women receiving one or two rubella vaccines.
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From page 233... ...
2002. Surveillance of measles-mumps rubella vaccine-associated aseptic meningitis in Germany.
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From page 234... ...
1999. Autism and measles, mumps, and rubella vaccine: No epidemiological evidence for a causal association.
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From page 235... ...
2004. MMR vaccination and febrile seizures: Evaluation of suscepti ble subgroups and long-term prognosis.
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From page 236... ...
1980a. Clinical and laboratory studies of combined live measles, mumps, and rubella vaccines using the RA 27/3 rubella virus.
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From page 237... ...
1994. Inadvertent administration of DTP and DT after age six as recorded in the Vaccine Adverse Event Reporting System.
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Key Terms
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