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Cited by 26Pharmacovigilance and Adverse Drug ReactionsVaccine Coverage and HesitancyIntramuscular injections and effects

No evidence of an association between MMR vaccine and gait disturbance

Open access
Miller, E·2005·Archives of Disease in Childhood
DOI 10.1136/adc.2003.048165PMC PMC1720314
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Abstract

BACKGROUND: MMR vaccine has been reported to cause gait disturbance, and this possible association has been claimed to support the MMR-causes-autism theory. AIMS: To determine whether any association between gait disturbance and MMR vaccination exceeds the age related background rate of gait disturbance, using record linkage and self control case series analyses. METHODS: MMR vaccination records were linked to hospital admission and general practitioner attendance data. An increased rate of gait problems with onset in various intervals in the 60 day period after MMR vaccination was looked for in children aged 12 to <24 months. RESULTS: No evidence of an increased rate of hospital admission or general practice consultations for gait disturbance was found in the putative post-vaccination risk periods. CONCLUSIONS: This study provides no evidence for a causal association between MMR and gait disturbance.

AI snapshot

Written from the paper’s full text.

TL;DR

This record-linkage self-controlled case series study found no evidence that MMR vaccination increases the risk of gait disturbance or ataxia in children aged 12 to <24 months. The only elevated consultation rate was in the 0–5 days after vaccination, driven by same-day consultations, with no increased risk in biologically plausible later periods.

Key findings

  • Hospital admissions: among 146 possible gait-disturbance admissions, 127 had case notes/immunisation records traced and 62 remained for analysis after excluding non-ataxic/non-viral cases. No category showed increased risk; probable post-viral ataxia (category 2) had RI 1.13 (95% CI 0.21 to 6.20) for 0–60 days, based on 2 cases at 22 and 34 days after MMR.
  • General practice: 1,403 children aged 12 to <24 months with possible gait disturbance were identified; 138,190 children had an MMR date recorded. The initial 0–30 day increase was due to same-day consultations; after subdividing, all cases had RI 1.88 (95% CI 1.30 to 2.72) at 0–5 days, 0.90 (0.70 to 1.17) at 6–30 days, 0.95 (0.77 to 1.19) at 31–60 days, and 0.93 (0.78 to 1.12) at 6–60 days.
  • Combined hospital category 2 plus GP ataxia category A gave RI 0.81 (95% CI 0.18 to 3.69) for 0–30 days and 0.96 (95% CI 0.33 to 2.82) for 0–60 days.
  • Thiomersal analyses showed no predictive association between early DTP/DT exposure and MMR-associated gait disturbance; for all cases at 6–60 days, RI was 0.82 (95% CI 0.60 to 1.12) with three doses by 4 months versus 0.99 (0.80 to 1.23) without, p=0.27, and mercury exposure quartiles gave p=0.76.

Methods

  • Record linkage of computerised hospital admission and immunisation records in the former North and South Thames regions, April 1995 to June 2001, covering approximately 509,000 children eligible for MMR; admissions with ICD-10 codes G111, G112, G25, R26, R27, R29, H55, and F984 were identified, validated by case note review, and grouped into five categories.
  • General Practice Research Database analysis included children born 1988–1997 with at least two years of continuous follow-up; 152,898 children were available, of whom 138,190 (90.3%) had an MMR date. Read/OXMIS codes for possible gait disturbance were grouped into six categories (A–F), with a 100-record validation subset.
  • Self-controlled case series analysis with age stratification in one-month intervals compared post-vaccination risk periods (0–30 and 31–60 days, later subdivided into 0–5 and 6–30 days) against background rates; additional analyses stratified by DTP/DT doses by 4 months and mercury exposure intensity quartiles.

Limitations

  • The paper states that GPRD validation was limited: adequate clinical information was obtained for only 37 of 100 selected cases (37%); 54 practices no longer participated, 5 children had transferred out, 1 GP did not respond, and 3 had no additional relevant information.
  • The paper states that clinical codes were chosen to maximise sensitivity rather than specificity, so many non-neurological gait-disturbance cases were included; hospital case notes were traced for 127 of 146 admissions (87%).
  • Evident from the text: this is an observational record-linkage study relying on computerised coding and vaccination records, with possible misclassification; the authors handled same-day consultations by excluding the 0–5 day period from later risk estimates, and some confidence intervals remained wide.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1136/adc.2003.048165

Cites

16 of 16 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 5 cited sources checked · 0 supported · 0 flagged

  • Findingown data
    § General practice consultations

    There was an increased incidence of consultation for any gait disturbance 0-5 days after MMR vaccination (RI 1.88, 95% CI 1.30 to 2.72).

    “the increased incidence of consultation for any gait disturbance 0-5 days after MMR vaccination (1.88, 95% CI 1.30 to 2.72)”
    Quote in the paperSubstantial claim
  • Findingown data
    § General practice consultations

    No post-vaccination risk period other than 0-5 days showed an increased incidence of consultation for gait disturbance.

    “no other post-vaccination risk period showed an increased incidence.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: Cases with gait problems diagnosed on the day of MMR vaccination are unlikely to be causally related to vaccination.
  • Findingown data
    § General practice consultations

    The increased incidence of consultation for any gait disturbance 0-5 days after MMR was attributable to an excess in categories B and C on the day of vaccination (12/31 of all events in the 0-5 day period).

    “attributable to an excess in categories B and C on the day of vaccination (12/31 of all events in the 0-5 day period)”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: Cases with gait problems diagnosed on the day of MMR vaccination are unlikely to be causally related to vaccination.
  • Findingown data
    § General practice consultations

    The initial analysis gave a significantly increased relative incidence for the 30-day post-vaccination period for unsteady gait (category B) and unspecified gait abnormality (category C), caused by an excess of consultations on the day MMR was given.

    “The initial analysis gave a significantly increased RI for the 30 day post-vaccination period for some categories of gait disturbance (B, unsteady; and C, unspecified) that was caused by a clear excess of consultations on the day that MMR was given.”
    Quote in the paperSubstantial claim
  • Findingown data
    § Hospital admissions

    For probable post-viral ataxia (category 2), the observed relative incidence in the 0-60 day post-vaccination risk period was 1.13 (95% CI 0.21 to 6.20), based on two cases admitted at 22 and 34 days after MMR.

    “For probable postviral ataxia, the category most closely resembling the cases described by Plesner, 1 the observed RI in the putative post- vaccination risk period was 1.13, based on a total of two cases admitted within 60 days of vaccination, at 22 and 34 days respectively after MMR.”
    • Also stated in: § DISCUSSION · hedged
      “Of the 19 hospital admitted cases that were categorised as most similar to those described by Plesner 1 (category 2), only two were in the putative post-vaccination risk period of 0-60 days after MMR vaccine (relative incidence 1.13, 95% CI 0.21 to 6.20).”
    Quote in the paperSubstantial claim
  • May combine two claims. 7
  • Classified as probably not a substantial claim. 13

  • May combine two claims.

    Findingown data
    § DISCUSSION

    Our incidence rates were 4.1 per 100,000 for hospital cases (category 2) and 17.4 per 100,000 for GPRD cases (category A).

    “Compared with Plesner's reported rate of six cases of gait disturbance per 100 000 MMR vaccinated children, our incidence rates were 4.1 per 100 000 for hospital cases (category 2) and 17.4 for GPRD cases (category A, a less definite group than the well validated hospital cases.)”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § Hospital admissions

    Of the 127 traced episodes, 114 (90%) had received MMR vaccine.

    “Of these, 114 (90%) had received MMR vaccine.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § General practice consultations

    Of 100 cases selected for validation, adequate clinical information was obtained on only 37 (37%).

    “Of the 100 cases selected for validation, adequate clinical information was obtained on only 37 (37%).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data
    § Hospital admissions

    The 62 analysed hospital episodes comprised 19 probable post-viral ataxias (category 2), 19 probably not post-viral ataxias (category 3), and 24 probable post-viral transient synovitis (category 5).

    “These 62 cases comprised 19 probable post-viral ataxias (category 2), 19 probably not post-viral ataxias (category 3), and 24 gait disturbances considered to be probable ''post-viral'' transient synovitis (category 5).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingown data
    § Hospital admissions

    A total of 146 admissions for possible gait disturbance were identified in children aged 12-24 months; case notes and immunisation records were traced for 127 (87%).

    “A total of 146 admissions for a possible gait disturbance were identified in children aged 12 to ,24 months for whom case notes and immunisation records were traced for 127 (87%).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Hospital admissions

    Non-ataxic, non-viral gait disturbance (category 4) was identified as the cause for admission in 65 of the 127 episodes, leaving 62 episodes for analysis, none of which met the category 1 definition.

    “Non-ataxic, non-viral gait disturbance (category 4) was identified as the cause for admission in 65 of the 127 episodes, leaving 62 episodes for analysis, none of which met the category 1 definition.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data
    § General practice consultations

    Of the 1403 children, 24 had a code for ataxia (category A), 79 unsteady gait (category B), 654 (47%) unspecified gait abnormality (category C), and 636 (45%) limp/limping gait (category D).

    “Of these, 24 had a code reflecting some form of ataxia (category A), and 79 had a code denoting unsteady gait (category B); 654 (47%) had a code denoting an unspecified gait abnormality (category C) and 636 (45%) had a code where the text description included the terms limp/ing [walk/gait] (category D).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Findingown data
    § General practice consultations

    A total of 1403 children aged 12-24 months presenting with possible gait disturbance were identified in the GPRD.

    “A total of 1403 children (1091 in the group with an exact date of birth and 312 in the group for which the day of birth was assigned to the 16th day of the month) aged 12 to ,24 months presenting with a possible gait disturbance, and in whom the date of the consultation preceded the last date when the practice data were deemed to be ''up to research standard'', were identified using the selected”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation
    § Abstract

    Plesner reported 24 cases of temporary gait disturbance in previously normal 15-month-old children shortly after MMR vaccine, at an incidence of 6 per 100,000 doses.

    “The cases were reported to the statutory adverse event notification system in Denmark between 1987 and 1995 at an incidence of 6 per 100 000 doses.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Plesner 1995

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § DISCUSSION

    The clinical codes used for identification of episodes were chosen to maximise sensitivity rather than specificity.

    “The clinical codes used for identification of episodes that might indicate the type of gait disturbance reported by Plesner 1 were chosen to maximise sensitivity (that is, minimise the number of true cases missed) rather than specificity (that is, minimise the number of non-cases identified).”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Premisecitation
    § Abstract

    The SCCS method allows the risk of events in specified post-vaccination periods to be compared with the age-specific background risk, without age-matched controls, while retaining the power of a cohort study.

    “The SCCS method allows the risk of events in specified post-vaccination periods to be compared with the age specific background risk, without the need for age matched controls yet retaining the power of a cohort study.3”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Farrington et al., 1996

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data
    § DISCUSSION

    Our study provides no evidence in support of speculations that MMR causes gait disturbance or autism.

    “Our study provides no evidence in support of these speculations and emphasises the importance of subjecting such claims to objective scientific scrutiny before invoking them in support of putative causal associations between MMR and various neurological conditions.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § METHODS

    Post-vaccination risk periods of 0-30 and 31-60 days after vaccination were specified a priori.

    “Post-vaccination risk periods of 0-30 and 31-60 days after vaccination were specified a priori after discussion with AM Plesner.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data
    § DISCUSSION

    The high proportion (around two thirds) of cases in the GPRD dataset where attempted validation was unsuccessful was disappointing.

    “The high proportion (around two thirds) of cases in the GPRD dataset, where attempted validation was unsuccessful, was disappointing.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisecitation
    § DISCUSSION

    The alleged association between MMR and gait disturbance has been invoked to support the belief that MMR vaccine causes autism.

    “The alleged association between MMR and gait disturbance has also been invoked to support the belief that MMR vaccine causes autism, as it is claimed that parents who suspect a causal link with the vaccine, frequently report gait disturbance in their previously normal children.13”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Wakefield & Montgomery 2000

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning
    § General practice consultations

    Opportunistic vaccination when children presented with coincidental gait disturbance, or expression of concerns about such symptoms when parents presented their child for immunisation, are more likely explanations for the excess consultations on the day of MMR.

    “Opportunistic vaccination when children pre- sented with coincidental gait disturbance, or expression of concerns about such symptoms when parents presented their child for immunisation, seem more likely explanations.”
    Quote in the paperSubstantial claim
    • The authors state this as an assumption: Cases with gait problems diagnosed on the day of MMR vaccination are unlikely to be causally related to vaccination.

  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § METHODS

    Categorisation of cases was carried out without knowledge of MMR vaccination status.

    “Categorisation of cases was carried out without knowledge of MMR vaccination status by BT.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductnone given
    § METHODS

    The ICD-10 diagnosis codes were validated by hospital case note review.

    “The ICD 10 diagnosis codes were validated by hospital case note review.”
    Quote in the paperSubstantial claim
18 of 18

  • The paper relies on this without support.

    If mercury is damaging, there should be a higher risk with earlier and higher dosage.

    “If mercury is damaging, there should be a higher risk with earlier and higher dosage.”

  • The authors state this as an assumption.

    Cases with gait problems diagnosed on the day of MMR vaccination are unlikely to be causally related to vaccination.

    “Based on biological plausibility arguments, such cases were considered unlikely to be causally related to the vaccination, an assumption that was confirmed by the subset that could be validated.”
2 of 2

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • In a self-controlled case series, relative incidence estimates for gait disturbance pooled across two, three and five categories were not statistically significant (RI 0.83; 95% CI 0.24 to 2.84 for 0 to 30 days and RI 0.20; 95% CI 0.03 to 1.47 for 31 to 60 days after MMR vaccination).

    “RI estimates for pooled two, three and five categories were not statistically relevant (RI 0.83; 95% CI 0.24 to 2.84 for 0 to 30 days risk time and RI 0.20; 95% CI 0.03 to 1.47 for 31 to 60 days risk time).”

    From Vaccines for measles, mumps and rubella in children (2012) · cites this paper as Miller 2005

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. Plesner AM. Gait disturbance after MMR vaccine. Lancet 1995;345:316.

Cited by

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Related

Authors
Miller, E.
Affiliations
Health Protection Agency (GB)
Corresponding author
Miller, E
ORCID
Miller, E
Venue
Archives of Disease in Childhood
Publisher
BMJ
Published
2005-03-01
Volume
90
Issue
3
Pages
292-296
ISSN
  • 0003-9888 (ISSN-L)
  • 1468-2044
DOI
10.1136/adc.2003.048165
PMC
PMC1720314
OpenAlex
W2027375988
Cited by
26
References
16
Citations by year
2024: 2 · 2021: 1 · 2020: 1 · 2019: 1 · 2018: 2 · 2016: 1 · 2015: 2 · 2014: 1 · 2013: 2 · 2012: 3
FWCI
2.52
Type
journal article
Language
en
Open access
Locations
  • Archives of Disease in Childhood (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
  • Health Sciences › Medicine › Emergency Medicine › Intramuscular injections and effects
Keywords
MMR vaccine, gait disturbance, autism spectrum disorder, vaccine adverse events, children aged 12-24 months, hospitalization, general practitioner visits, data linkage
MeSH terms
England, Family Practice, Hospitalization, Humans, Infant, Patient Acceptance of Health Care, Risk Factors, Gait Disorders, Neurologic, Measles-Mumps-Rubella Vaccine

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