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Comparability of Vaccine Safety Data Dr. med. Jan Bonhoeffer

Comparability of Vaccine Safety Data Dr. med. Jan Bonhoeffer Coordinator, The Brighton Collaboration University Children’s Hospital Basel. 2 Challenges To Comparability. Safety assessed indirectly No standardization: of Case definitions of Guidelines.

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Comparability of Vaccine Safety Data Dr. med. Jan Bonhoeffer

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  1. Comparability of Vaccine Safety Data Dr. med. Jan Bonhoeffer Coordinator, The Brighton Collaboration University Children’s Hospital Basel

  2. 2 Challenges To Comparability • Safety assessed indirectly • No standardization: of Case definitions of Guidelines

  3. Lack of Standardized Case Definitions • WHO and CIOMS definitions -Not exaustive -Not widely used • Literature search -Large diversity of safety methods

  4. Temperature Cut-offsStudy protocols and surveillance systems Number of Studies (N=120)* 37.5 38.0 38.3/ 38.5 39.0 39.5 40.0 40.5 “Fever” 37.8 Temperature (>=) °C *Some studies with >1 cut off

  5. Cut-offs for Erythema & Swelling & IndurationStudies and Surveillance Systems Number of studies* (N=102) Cut off points in mm *Some studies with >1 cut off

  6. The Brighton Collaboration Enables Comparability • Develops case definitions for AEFI • Promotes global implementation of case definitions

  7. 4 Step Process To Develop Case Definitions • Search for existing case definitions • Develop draft definitions • Review and evaluate draft definitions 4) Finalize and disseminate definitions

  8. First Six AEFI Definitions • Fever • Local Reactions • Intussusception • Persistent Crying • Generalized Convulsive Seizure • Hypotonic- Hyporesponsive Episode

  9. Brighton Collaboration Case Definition Format Level 1 of diagnostic certainty Level 2 of diagnostic certainty Level 3 of diagnostic certainty

  10. Intussusception • Level 1 • Surgical criteria AND/OR • Radiological criteria AND/OR • Autopsy criteria • Level 2 • Clinical criteria • 2 major OR 1 major & 3 minor criteria • Level 3 • Clinical criteria • > 4 minor criteria

  11. Fever Level 1 Endogenous elevation of at least one measured body temperature of >38° C Level 2Not applicable Level 3Not applicable

  12. 4 Step Process To Develop Guidelines • Create draft definitions • Apply to real cases • Test for comparability • Formulate needed guidelines

  13. Guidelines for Investigators • Data collection e.g. vaccine, other medication, outcome • Data Analysis e.g. 5 categories, predefined increments • Data Presentation e.g. numerator and denominator, distribution of data

  14. Five Categories for Data Analysis Case definition Level 1 of diagnostic certainty Level 2 of diagnostic certainty Level 3 of diagnostic certainty Additional categories for data analysis • Reported [AEFI] with insufficient evidence • to meet the case definition • No, it is not a case of [AEFI]

  15. AEFI Definition Document Format • Preamble • Definition • Guidelines

  16. Structure of Brighton Collaboration • Steering committee • Working groups: Case definition • Working group: Methods • Reference group

  17. Board Elisabeth Loupi Bob Chen Phillippe Duclos Ulrich Heininger Harald Heijbel Tom Jefferson Secretariat Katrin Kohl Jan Bonhoeffer Bakary Drammeh Steering Committee

  18. Allergic Reaction SIDS ITP Myalgia CFS Paresthesia Smallpox AEFI Next Steps • Build reference group • Build next 7 working groups • Dissemination and Implementation

  19. Country Distribution of Participants Date: October 2002 322 Participants 42 Countries

  20. Join the Collaboration ! • Use definitions, guidelines • Be part of reference group • Be part of working groups We need aWorking Group Coordinator NOW!!

  21. secretariat@brightoncollaboration.org http://brightoncollaboration.org

  22. Funding • Centers for Disease Control and Prevention • EUSAFEVAC – European Research Program of Improved Vaccine Safety Surveillance • World Health Organization

  23. Fever Level 1 Endogenous elevation of at least one measured body temperature of >38° C Level 2 Not applicable Level 3 Not applicable

  24. Injection Site Nodule • Level 1 • The presence of • Discrete or well demarcated soft tissue mass • Firm AND • At injection site • In the absence of • Abscess formationAND/OR • Warmth • Erythema • Level 2Not applicable • Level 3Not applicable

  25. Abscess at injection site Abscess is defined by • localized soft tissue collection of fluid • with or without fluctuance • at the site of immunization

  26. Abscess of Infectious Etiology *Level 1 The presence of • Spontaneous or surgical drainage of purulent material from mass AND • Laboratory confirmation *may be accompanied by fever and/or regional lymphadenopathy.

  27. Abscess of Infectious Etiology Level 2 The presence of • Spontaneous or surgical drainage of purulent material from the mass OR • Fluid collection diagnosed by imaging technique AND • Localized sign(s) of inflammation AND/OR • Prompt resolution with antimicrobial therapy

  28. Abscess of Infectious Etiology Level 3 • Not applicable

  29. Swelling at injection site Level 1* The presence of Measured enlargement of injection site / limb                 ORVisible enlargement of injection site / limb described as "joint to joint" or "crossing joints" * the swelling may be accompanied by some erythema and tenderness

  30. Swelling at injection site Level 2* Reported visible enlargement of injection site/limb without objective measurement or specified anatomical description. Level 3 not applicable The following alone do not constitute 'swelling': An isolated injection site nodule, abscess, cellulites, induration * the swelling may be accompanied by some erythema and tenderness

  31. Cellulitis at injection site Cellulitis is defined as an acute, infectious, expanding inflammatory condition of the skin that is characterized by ……

  32. Cellulitis at injection siteLevel 1 The presence of (at least 3 of the following five) ● localized pain AND/OR ● tenderness to light touch AND/OR ● intense erythema AND/OR ● at least moderate induration AND/OR ● substantial local warmth AND ● is at the injection site AND ● laboratory confirmation

  33. Cellulitis at injection siteLevel 1 continued In the absence of ● spontaneous rapid resolution AND/OR ● fluctuance OR The presence of ● a physician diagnosis of cellulitis AND ● is at the injection site AND ● laboratory confirmation

  34. Cellulitis at injection siteLevel 2 The presence of (at least 3 of the following five) ● localized pain AND ● tenderness to light touch AND ● intense erythema AND ● at least moderate induration AND ● substantial local warmth AND ● is at the injection site AND ● health care provider diagnosis In the absence of ● spontaneous rapid resolution AND/OR ● fluctuance

  35. Cellulitis at injection siteLevel 3 The presence of (any of the following five) ● localized pain AND/OR ● tenderness to light touch AND/OR ● intense erythema AND/OR ● at least moderate induration AND/OR ● substantial local warmth AND ● is at the injection site2 AND ● health care provider diagnosis In the absence of ● spontaneous rapid resolution AND/OR ● fluctuance

  36. Cellulitis at injection siteLevel 3 (continued) OR The presence of (at least 3 of the following five) ● localized pain AND ● tenderness to light touch AND ● intense erythema AND ● at least moderate induration AND ● substantial local warmth AND ● is at the injection site AND ● non health care provider report

  37. Intussusception • Level 1 • Surgical criteria AND/OR • Radiological criteria AND/OR • Autopsy criteria • Level 2 • Clinical criteria • 2 major OR 1 major & 3 minor criteria • Level 3 • Clinical criteria • > 4 minor criteria

  38. Inconsolable Crying Level 1 The presence of Loud sustained vocalization, which ispersistent, i.e. continuous AND unaltered for > 3 hours In the absence of Response to any attempt to console the crying (e.g. by means of feeding, comforting, analgesics) Level 2Not applicable Level 3Not applicable

  39. Generalized Convulsive Seizure Level 1 • Witnessed sudden loss of consciousness AND • Generalized, tonic, clonic, tonic-clonic or atonic motor manifestations

  40. Generalized Convulsive Seizure Level 2 • History of unconsciousness AND • generalized tonic, clonic or tonic-clonic or atonic motor manifestations Level 3 • History of unconsciousness AND • Other generalized motor manifestations

  41. HHE Level 1 The sudden onset of • Limpness (muscular hypotonia) AND • Hypo-responsiveness or unresponsiveness AND • Pallor or cyanosis

  42. HHE Level 2 The sudden onset of ·Two of the three definite inclusion criteria Level 3  The sudden onset of ·Two of the three definite inclusion criteria AND ·The third one noticed to be absent

  43. 0-12 months FEVER CONVULSION AGITATION SIDS APNEA STUPOR HYPOTONIA CYANOSIS VOMIT SOMNOLENCE 1 year FEVER CONVULSION FEB SEIZURE RASH STUPOR AGITATION VOMIT OTITIS MED SOMNOLENCE APNEA 2-18 years FEVER CONVULSION VOMIT HEADACHE RASH ASTHENIA STUPOR SOMNOLENCE DYSPNEA HYPOKINESIA 1 2 3 4 5 6 7 8 9 10 Top 10 Serious* AEFI**, by Age Group >18years FEVER ASTHENIA PARESTHESIA GUILLAIN BARRE PAIN MYALGIA ARTHRALGIA HEADACHE DYSPNEA MYASTHENIA * Per FDA criteria **Source: VAERS, 1991-2000 Yellow = Currently included AEFI; Green = Next AEFI to be defined

  44. 0-12 months FEVER AGITATION SCREAMING CRY ABNORMAL HYSN INJ SITE EDEMA INJ SITE SOMNOLENCE RASH VOMIT HYPOTONIA 1 year FEVER RASH AGITATION HYSN INJ SITE RASH MAC PAP VASODILAT CONVULSION EDEMA INJ SITE URTICARIA RASH VESIC BULL 2-18 years FEVER HYSN INJ SITE VASODILAT EDEMA INJ SITE RASH URTICARIA PRURITUS PAIN INJ SITE VOMIT PAIN >18years HYSN INJ SITE FEVER VASODILAT MYALGIA PAIN INJ SITE EDEMA INJ SITE PAIN PRURITUS RASH HEADACHE 1 2 3 4 5 6 7 8 9 10 Top 10 Non-Serious* AEFI**, by Age Group * Per FDA criteria **Source: VAERS, 1991-2000 Yellow = Currently included AEFI; Green = Next AEFI to be defined

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