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Management of Smallpox Vaccine Adverse Events

Management of Smallpox Vaccine Adverse Events. Department of Health and Human Services Centers for Disease Control and Prevention February 2003. Management of Smallpox Vaccine Adverse Events. Learning Objectives: Describe the treatment and management of vaccinia adverse events (AEs)

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Management of Smallpox Vaccine Adverse Events

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  1. Management of Smallpox Vaccine Adverse Events Department of Health and Human Services Centers for Disease Control and Prevention February 2003

  2. Management of Smallpox Vaccine Adverse Events • Learning Objectives: • Describe the treatment and management of vaccinia adverse events (AEs) • Describe the use of Vaccinia Immune Globulin (VIG) and Cidofovir

  3. Adverse Events Associated with Smallpox Vaccine • Inadvertent inoculation • Ocular vaccinia • Generalized vaccinia • Eczema vaccinatum • Progressive vaccinia • Post-vaccinial Encephalopathy • Encephalomyelitis • Fetal Vaccinia

  4. Local Skin ReactionsIrritation from Adhesive Dressing

  5. Non-Specific RashesErythematous Patches

  6. Dermatologic Manifestations of Hypersensitivity ReactionsErythema Multiforme

  7. Dermatologic Manifestations of Hypersensitivity ReactionsStevens-Johnson Syndrome

  8. Vaccinia Specific Adverse EventsInadvertent Inoculation

  9. Vaccinia Specific Adverse EventsKeratitis

  10. Treatment of Ocular InfectionsGuidance for Clinicians • Manage in consult with ophthalmologist • Consider off-label use of topical ophthalmic trifluridine or vidarabine • Balance with risk of drug toxicity • Continue until periocular and/or lid lesions heal and scabs fall off

  11. Treatment of Ocular InfectionsGuidance for Clinicians • Consider VIG when keratitis NOT present • Useful with severe blepharitis or blepharoconjunctivitis • Weigh risks and benefits if keratitis present • Use VIG for other severe vaccinia disease, even if keratitis present • Consider prophylaxis against bacterial infection • Enroll in studies

  12. Prevention of Contact Transmission • Proper hand-hygiene • Healthcare Setting • Cover with gauze • Cover gauze with semi-permeable dressing • Until scab separates • Non-Healthcare Setting • Cover with gauze • Wear sleeve over site

  13. Generalized Vaccinia

  14. Eczema Vaccinatum

  15. Progressive Vaccinia

  16. Post-Vaccinial EncephalitisDiagnostic and Management • None for specific diagnosis of PVE • Diagnosis of exclusion – Consider other infectious or toxic etiologies • 15-25% mortality rate • 25% varying neurological deficits • VIG not recommended

  17. Fetal Vaccinia

  18. Prophlyaxis of High-Risk Groups Accidentally Exposed • VIG NOT recommended • Vigilant clinical follow-up • Do NOT administer VIG with smallpox vaccine • Exclude those with contraindications

  19. Vaccinia Immune Globulin • Immunoglobulin fraction of plasma • Antibodies to vaccinia from vaccinated donors • Previously-licensed IM product (Baxter) • Contains 0.01% thimerosal • New IV products in production • Obtain as IND product through CDC and DoD

  20. Vaccinia Immune GlobulinIndications

  21. Vaccinia Immune GlobulinSide Effects - Mild • Local Pain • Tenderness • Swelling • Erythema • From few hours to 1 or 2 days

  22. Vaccinia Immune GlobulinSide Effects - Moderate • Joint Pain • Diarrhea • Dizziness • Hyperkinesis • Drowsiness • Pruritis • Rash • Perspiration • Vasodilation

  23. Vaccinia Immune Globulin Contraindications • Allergic reaction to thimerosal • History of severe reaction with IG preparations • IgA Deficiency • Vaccinia keratitis, except in some cases • Pregnancy • Theoretical risks as with all human plasma

  24. VIG Administration • VIG-IM 0.6ml/kg • IM, preferably in buttock or anterolateral aspect of thigh • Divide doses > 5ml • Refer to package insert

  25. Cidofovir • Nucleotide analogue of cytosine • Some antiviral activity against orthopoxviruses • Administer under IND protocol, only • Released by CDC and DoD if: • No response to VIG • Patient near death • All inventories of VIG exhausted

  26. Cidofovir Side Effects • Renal toxicity • Neutropenia • Proteinuria • Decreased intraocular pressure • Anterior uveitis/iritis • Metabolic acidosis

  27. Cidofovir Admin • 5 mg/kg IV over 60 minute period • Consider 2nd dose one week later if no response • Adjust dose for renal function • Assess baseline and post-admin renal function • IV hydration (1L of 0.9% saline IV) • 3 doses oral probenicid (25 mg/kg per dose)

  28. For More Information • CDC Smallpox website www.cdc.gov/smallpox • National Immunization Program website www.cdc.gov/nip

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