About the Vaccine/Contraindications Vaccination Method Normal Primary Vaccination Normal Variants/Revaccination Vaccinia Immune Globulin (VIG)

Smallpox Vaccination About the Vaccine Recommended Vaccination Method Normal Reaction Timeline Vaccinia Immune Globulin (VIG) was produced in the The vaccinia (smallpox) vaccine is a live virus that Multiple puncture vaccination on the deltoid area of the 1960's from plasma obtained from recently vaccinated Day Description Vaccination Method & Reactions multiplies in the superficial layers of the skin. It does not upper arm, using an individually wrapped, sterile, donors and was administered intramuscularly (IM-VIG). contain variola virus, the virus that causes smallpox. A bifurcated needle. 0 Vaccination Recently, intravenous VIG (IV-VIG) has also been 3-4 Papule Because routine smallpox vaccination ceased successful vaccination is often referred to as a “take.” produced. 5-6 Vesicle with surrounding erythema -> 30 years ago, many clinicians are unacquainted Two vaccine types will be used in the coming years: Bifurcated Needle vesicle with depressed center Vials of IM-VIG and IV-VIG are stored at the CDC and with the vaccinia (smallpox) vaccine. 1. Calf-lymph vaccine: Dryvax (Wyeth and Aventis) 8-9 Well-formed pustule are available only under IND protocols. Satellite Lesions Lymphangitis Edema 2. Tissue culture cell vaccine (Acambis/Baxter) Step-by-Step Instructions 12+ Pustule crusts over -> scab This pocket guide provides health care personnel 1. NO alcohol: vaccination will be inhibited. No skin Dip Needle Retained Vaccine 17-21 Scab detaches revealing scar VIG Administration with concise information on the vaccine, method Immunity Normal Variants 1. preparation is required prior to vaccination. Normal variants (rate: 2.4% - 6.6%) are NOT adverse Indicated • Accidental implantation of vaccination and the nature of the expected Primary vaccination Fades after 5 years, after 20 2. Dip needle in vaccine vial; a minute drop is retained. No Reaction events and require no specific treatment. (extensive lesions) responses to vaccination. Additional in-depth years probably negligible 3. Make 3 or 15 (see package insert) perpendicular A non-reaction means no immunity and vaccination • Eczema vaccinatum information is available by visiting: They include: Revaccination Found to persist 30+ years (1) insertions within a 5-mm diameter area. must be repeated. • Satellite lesions • Generalized vaccinia www.bt.cdc.gov/agent/smallpox NOTE: Strokes should be vigorous enough to evoke a • Lymphangitis from the site to regional nodes (if severe or recurrent) Vaccination after Within 2-3 days, can protect Systemic Symptoms trace of blood after 15-30 seconds. • Regional lymphadenopathy • Progressive vaccinia exposure to smallpox against smallpox The guide also includes images and text to help 4. Absorb excess vaccine with sterile gauze and discard Approximately one week after vaccination: • Considerable local edema at the site Within 4-5 days, may protect differentiate the more common, self-limiting gauze in a biohazard waste receptacle. • Fever • Intense erythema (viral cellulitis) Not • Accidental implantation against a fatal outcome • Malaise Day 8 adverse reactions of vaccination from those that 5. Cover site with sterile gauze (loosely taped). Proper Position 3 or 15 Insertions Recommended (mild instances) (1) May protect against a fatal outcome, but not against developing a milder • Myalgia are serious and may require intervention. form of smallpox 6. Prevent contact transmission. Revaccination • Generalized vaccinia Unlike other immunizations, smallpox vaccination is • Soreness at the vaccination site Most vaccinees experience only a mild fever and local Potential revaccination responses: (mild or limited - most instances) Contraindications for Vaccinees & Their Close characterized by a virus that propagates in the skin • Local lymphadenopathy discomfort with localized redness and swelling. • Erythema multiforme Physical Contacts (E.g., Household Members) • Intense erythema ringing the vaccination Response Description and can potentially contaminate the vaccinee's hands • Vaccinia keratitis • Pregnancy or the skin and mucosa of others with whom the Typical primary reaction Clear-cut pustule 6-8 days after (see back of guide for details) • Immunodeficiencies vaccination vaccinee comes into contact. • Post-vaccinial encephalitis • Extensive skin diseases (1) Caution vaccinee and/or guardian (until scab has • Immunosuppressive therapies (2) Major reaction Area of definite induration or Dosage fallen off on its own) to: • Inflammatory eye diseases (3) congestion surrounding a central The usual dose of IM-VIG is 0.6 ml/kg body weight. • Keep the vaccination site covered • Atopic dermatitis (eczema); present, past, or “healed” Post-insertion Absorb Excess lesion that may be a scab or As much as 1-10 ml/kg body weight has been used in • Do not touch, scratch or rub the site, even though • Vaccine component allergy (4) ulcer 6-8 days after vaccination. serious, life-threatening complications. • it is itchy • Breastfeeding (5) The evolution of the lesion is To calculate the weight-based dose of IV-VIG, refer to • Avoid person-to-person contact with susceptible • Less than 12 months of age (5) more rapid than following a the IND protocol or package insert that accompanies (1) E.g., acne, burns, wounds, recent incisions, impetigo, contact dermatitis • individuals (see contraindications) Day 6 Day 8 Day 10 Day 14 primary reaction. the IV-VIG product. Repeated doses may be necessary (2) E.g., cancer therapy, organ transplants, other conditions with therapy • Avoid touching, rubbing or any other maneuvers to fully treat adverse events such as eczema (3) Only in vaccinee with eye disease or on steroid eye therapy • that might transfer vaccinia virus to the eye or Equivocal reaction Any other reaction or response; vaccinatum or progressive vaccinia that present with (4) Vaccinee (only) allergy to Dryvax component: polymyxin B sulfate, streptomycin • surrounding skin sulfate, chlortetracycline hydrochloride, neomycin sulfate E.g., an "allergic" reaction more severe clinical manifestations. • Discard used gauze safely in a sealed plastic bag (5) Only in vaccinee (revaccination is indicated) or • After handling used gauze, thoroughly wash hands no reaction (revaccination is Vincent A. Fulginiti MD, Senior Author & Editor, University of Arizona Discard Properly Sterile Cover DA Henderson MD MPH, Editor, HHS Smallpox Outbreak indicated) Art Papier MD, Editor, University of Rochester Health care worker caution: Treat contaminated materials In the event of a smallpox outbreak, those who normally Photographs courtesy of Vincent Fulginiti MD, C. Henry Kempe’s Estate, NIH, NEJM, would have a contraindication for vaccination, but who as infectious waste. At work, cover gauze bandage with If a patient has never had a successful take, the patient CDC and Logical Images, Inc. All photographs are printed with the permission of semipermeable dressing and pay strict attention to hand the copyright holders and may not be reproduced without the written permission of are at risk of exposure to smallpox, would be offered should be informed that he/she is almost certainly NOT the copyright holders. the vaccination. hygiene. Day 6 Day 8 Day 10 Day 14 immune. Copyright © by Logical Images, Inc. Version 2.0, 2/03 www.logicalimages.com ADVERSE REACTIONS Adverse Reactions: Accidental Implantation Adverse Reactions: Bacterial Infections Adverse Reactions: Eczema Vaccinatum Adverse Reactions: Erythema Multiforme Adverse Reactions: Generalized Vaccinia Adverse Reactions: Progressive Vaccinia Adverse Reactions: Vaccinia Keratitis

Smallpox (vaccinia) vaccination is a generally Accidental Implantation Bacterial Infections Eczema Vaccinatum Erythema Multiforme Generalized Vaccinia Progressive Vaccinia Vaccinia Keratitis safe, effective preventative against smallpox. Accidental implantation by autoinoculation or contact Bacterial infections of the vaccination site are not Individuals with eczema (i.e., atopic dermatitis), active Toxic and/or hypersensitivity rashes are common 1-2 Generalized vaccinia is rare, usually benign, and the Progressive vaccinia is a rare complication occurring Although rare, vaccinia virus can be implanted into the Some individuals may experience an adverse event; is one of the most common adverse events. Although common. Children are at greater risk as they may or healed, are at special risk from implantation of weeks after vaccination. The rash varies from erythema- result of viremia. Within a week, lesions appear on any primarily in T-cell deficient persons. Congenital T-cell periorbital structures and even into the cornea. Viral many are harmless, a few are mild to moderate and no age group is spared, infants and children are most manipulate the site more often and contaminate the vaccinia virus into the diseased skin, sometimes with tous macular lesions, to vesicles, urticaria, pustules and part of the body (most often on the trunk and abdomen, deficient children, those with T-cell deficient diseases replication and the immune response lead to ulceration require specific treatment, and rarely, more serious susceptible to more extensive inoculations because of vaccination. Occlusive dressings may lead to maceration a fatal outcome. typical bulls-eye lesions, all under the rubric “erythema less commonly on the face, limbs, palms and soles). (cancer, immunosuppressive therapy, HIV/AIDS) are with subsequent corneal scarring or clouding. adverse events occur in susceptible individuals. their tendency to scratch an itching vaccination site. and increased risk of infection. multiforme”. These are benign lesions that do not pro- Lesions undergo rapid evolution to scarring. Rarely, at risk. Transfer of vaccinia virus can occur from autoinoculation gress. Itching may accompany the rash. The most serious lesions may recur at 4-6 week intervals for as long as Ten days after inoculation the clinical signs appear; Reporting Adverse Events This surface virus is easily transferred to the hands The most common organisms are Staphylococcus aureus or from contact with a vaccinee whose lesion is in the reaction, Stevens-Johnson Syndrome (SJS) is rare. one year. The primary vaccination fails to heal and spreads locally a central, grayish, disciform corneal lesion is most To report adverse events or request consultation about and to fomites. Either may be the source of inoculation and Group A Beta Hemolytic Streptococci. Anaerobic florid stages. Because most individuals have large con- and by viremia to other parts of the body; each lesion common. Topical antiviral agents are the treatment an adverse event, please call your state or local public elsewhere, but most implantations occur as a result of organisms occasionally infect the site. Impetiginous tiguous patches of skin in the affected areas, confluent Diagnosis is by typical rash seen in temporal association Subtle minor immunologic abnormalities, particularly spreads without inflammatory response. Untreated of choice in consultation with an experienced health authorities. transfer from hand to skin or to mucosa. vesiculo-pustular lesions are seen in staph infection and lesions are the rule (on the face and limbs primarily). with primary vaccination. In the vesicular and pustular of the immunoglobulin B-cell system, are suspected to patients succumb to viral effect or to secondary fungal, ophthalmologist. piled-up eschar formation is common in streptococcal forms it is necessary to distinguish these from general- be present. Differentiate from erythema multiforme, parasitic or bacterial infections. Accidental Administration Lesions follow the same course as the primary vaccina- infections, although lesions identical to the staph infec- Diagnosis may be more difficult in contact cases, because ized vaccinia or inoculation vaccinia. The vesicles and eczema vaccinatum, progressive vaccinia, severe chicken- Vaccinia Immune Globulin (VIG) is not recommended Occasionally, an individual may ingest vaccine accidentally tion, except in patients with cell-mediated immune tions also occur. Mixed infections may be encountered. history of contact with a vaccinee may be unknown or pustules in erythema multiforme do not progress into pox and smallpox. Consultation with an immunologist is Complications include septic shock, disseminated for vaccinia keratitis, but should be given if it occurs as or may be injected inadvertently by the intramuscular or dysfunction where each lesion progresses without an unappreciated as to risk. typical vaccinations and usually can be distinguished on strongly recommended. intravascular coagulation, and superimposed microbial part of a life-threatening complication, such as eczema subcutaneous route. These are not recommended routes inflammatory response, does not heal, and expands. Bacterial cultures should be obtained from the site by this basis. infections. If viable lymphocytes are administered, the vaccinatum or progressive vaccinia, in which case it of administration. It is prudent to follow the individual swabbing or aspiration. With early recognition and prompt treatment with Vaccinia Most instances of generalized vaccinia, particularly if patient may experience graft-versus-host disease. must be administered. In instances of severe clinically and to examine the administration site for a If there are only one or a few lesions, no specific treat- Immune Globulin (VIG), mortality can be reduced to zero, Treatment is symptomatic, usually employing an anti- the lesions are few, require no specific therapy. In some periorbital disease accompanied by keratitis, VIG is not vaccination lesion. Severity: Benign Frequency: Rare ment is required. Multiple lesions, especially if they are Treatment is with antibiotics specific to the agent. Initial and morbidity alleviated. Scarring may be extensive. histamine and measures to counteract itching, if present. cases, with extensive lesions, or in recurrent disease, Viral and immunologic laboratory investigation is recommended, but some experts believe that it can be confluent and cover large portions of the body warrant treatment should anticipate staphylococcal and strepto- Mucosal involvement and evolution into SJS requires Vaccinia Immune Globulin (VIG) should be administered. mandatory. Therapy consists of intensive administration administered in a single dose at 0.6 ml/kg, or at most Post-Vaccinial Encephalitis treatment with Vaccinia Immune Globulin (VIG). coccal etiology. Severity: Severe, especially if untreated hospitalization and supportive care. of antibody, usually in the form of Vaccinia Immune two such doses. Post-vaccinial encephalitis is a rare complication of Frequency: Somewhat common Severity: Benign, avoid hospitalization Globulin (VIG). primary vaccination (15/million). Encephalitis occurs Severity: Mild to severe - hospitalize severe Severity: Mild VIG: Indicated Severity: Benign (exception: recurrent generalized vaccinia - hospitalize) Severity: Severe if untreated 10-14 days after vaccination with headache, vomiting, Frequency: Common Frequency: Unknown (exception: Stevens-Johnson Syndrome (SJS) - severe) Frequency: Rare Severity: Severe - hospitalize Frequency: Rare drowsiness and fever as the first symptoms. In severe VIG: Indicated with extensive lesions VIG: Not recommended Frequency: Most common (exception: SJS - rare) (exception: recurrent generalized vaccinia - very rare) Frequency: Rare VIG: Not recommended as noted above, consult with cases life-threatening complications can develop. VIG: Not recommended for mild instances VIG: Not recommended VIG: Indicated (if severe or recurrent) VIG: Indicated CDC for up-to-date information Severity: Severe - hospitalize Frequency: Rare Not recommended (if mild or limited - most instances)