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 () 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. contain variola virus, the virus that causes smallpox. A bifurcated needle. 0 Vaccination 3-4 Because routine smallpox vaccination ceased successful vaccination is often referred to as a “take.” Vials of intramuscular VIG (IM-VIG) are stored at the 5-6 Vesicle with surrounding -> 30 years ago, many clinicians are unacquainted CDC and are available only under IND protocols. An Two vaccine types will be used in the coming years: Bifurcated Needle vesicle with depressed center with the vaccinia (smallpox) vaccine. effort is underway to produce new lots that will meet 8-9 Well-formed pustule 1. Calf-lymph vaccine: Dryvax (Wyeth and Aventis) Satellite Lesions Lymphangitis Edema the standards for intravenous VIG (IV-VIG). 2. Tissue culture cell vaccine (Acambis/Baxter) Step-by-Step Instructions 12+ Pustule crusts over -> scab This pocket guide provides health care personnel Dip Needle Retained Vaccine 17-21 Scab detaches revealing scar Normal Variants VIG Administration with concise information on the vaccine, method Immunity 1. NO alcohol: vaccination will be inhibited. No skin of vaccination and the nature of the expected 1. preparation is required prior to vaccination. Normal variants (rate: 2.4% - 6.6%) are NOT adverse Indicated • Accidental implantation Primary vaccination Fades after 5 years, after 20 No Reaction responses to vaccination. Additional in-depth 2. Dip needle into vaccine vial; a minute drop of vaccine events and require no specific treatment. • (extensive lesions) years probably negligible A non-reaction means no immunity and vaccination information is available by visiting: is retained. They include: • Eczema vaccinatum must be repeated. Revaccination Found to persist 30+ years (1) 3. Make 15 perpendicular insertions within a 5-mm • Satellite lesions • Generalized vaccinia www.bt.cdc.gov/training/smallpoxvaccine/reactions diameter area. NOTE: Strokes should be vigorous • Lymphangitis from the site to regional nodes • (if severe or recurrent) Vaccination after Within 2-3 days, can protect Systemic Symptoms enough to evoke a trace of blood after 15-30 seconds. • Regional lymphadenopathy • Progressive vaccinia The guide also includes images and text to help exposure to smallpox against smallpox Approximately one week after vaccination: 4. Absorb excess vaccine with sterile gauze and discard • Considerable local edema at the site differentiate the more common, self-limiting Within 4-5 days, may protect • Fever gauze in a biohazard waste receptacle. • Intense erythema (viral ) Not • Accidental implantation adverse reactions of vaccination from those that against a fatal outcome • Malaise Day 8 5. Cover site with sterile gauze (loosely taped). Proper Position 15 Insertions Recommended • (mild instances) are serious and may require intervention. • Myalgia 6. Prevent contact transmission. Revaccination • Generalized vaccinia (1) May protect against a fatal outcome, but not against • Soreness at the vaccination site Most vaccinees experience only a mild fever and local developing a milder form of smallpox Unlike other immunizations, smallpox vaccination is Potential revaccination responses: • (mild or limited - most instances) • Local lymphadenopathy discomfort with localized redness and swelling. characterized by a virus that propagates in the skin • Intense erythema ringing the vaccination Response Description • Erythema multiforme and can potentially contaminate the vaccinee's hands • Post-vaccinial encephalitis Contraindications for Vaccinees & Potential Contacts Typical primary reaction Clear-cut pustule 6-8 days after or the skin and mucosa of others with whom the • Pregnancy vaccination • Immunodeficiencies vaccinee comes into contact. Contraindicated • Vaccinia keratitis (may produce • severe corneal opacities) • Extensive skin diseases (1) Caution vaccinee and/or guardian (until a scab has Major reaction Area of definite induration or • Immunosuppressive therapies (2) formed) to: congestion surrounding a central Dosage • Inflammatory eye diseases (3) • Keep the vaccination site covered Post-insertion Absorb Excess lesion that may be a scab or The usual dose of IM-VIG is 0.6 ml/kg body weight. • Eczema; present, past or “healed” () • Do not touch, scratch or rub the site, even though 6-8 days after vaccination. As much as 1-10 ml/kg body weight has been used in • Vaccine component allergy (4) • it is itchy The evolution of the lesion is more rapid than following a serious, life-threatening complications. (1) E.g., , burns, wounds, recent incisions, , • Avoid person-to-person contact with susceptible • individuals (see contraindications) primary reaction. Day 6 Day 8 Day 10 Day 14 The exact dose of IV-VIG has not been determined but (2) E.g., cancer Rx, organ transplants, other conditions with Rx • Avoid touching, rubbing or any other maneuvers most likely will be administered at a lower dose than (3) Implantation by rubbing of eye; no immune defect present • that might transfer vaccinia virus to the eye or Equivocal reaction Any other reaction or response; the intramuscular preparation. (4) Dryvax contains: polymyxin B sulfate, streptomycin • surrounding skin e.g., an "allergic" reaction sulfate, chlortetracycline hydrochloride and neomycin sulfate • Discard used gauze safely in a sealed plastic bag (revaccination is indicated) or • After handling used gauze, thoroughly wash hands Discard Properly Sterile Cover no reaction (revaccination is Vincent A. Fulginiti MD, Senior Author & Editor Smallpox Outbreak indicated) Professor Emeritus, University of Arizona In the event of a smallpox outbreak, those who normally Health care worker caution: Treat contaminated materials would have a contraindication for vaccination, but who as infectious waste (e.g., towels, gowns, instruments, If a patient has never had a successful take, the patient 3445 Winton Place, Suite 212 Rochester, NY 14623 are at risk of exposure to smallpox, would be offered etc.). These materials should be placed in an appropriate should be informed that he/she is almost certainly NOT 1.800.357.7611 the vaccination. biohazard container. Day 6 Day 8 Day 10 Day 14 immune. 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 are common 1-2 Generalized vaccinia is rare, usually benign, and the Progressive vaccinia is a rare complication occurring Although a rare occurrence, vaccinia virus can be 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 varies from erythema- result of viremia. Within a week, lesions appear on any primarily in T-cell deficient persons. Congenital T-cell implanted into diseased or injured conjunctiva and 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 cornea resulting initially in viral replication with ulcera- 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 tion and ultimately in an antigen-antibody interaction 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. leading to corneal cloudiness. 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 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 Ten days after transfer the clinical signs of infection (a 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 central, grayish, disciform corneal lesion) can be seen. 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 VIG is contraindicated for use in vaccinial keratitis. 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, Topical antiviral agents are the treatment of choice in 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. consultation with an experienced ophthalmologist. 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- 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 Severity: Severe if untreated 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 Frequency: Rare 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 VIG: Contraindicated 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. 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 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 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 Photographs courtesy of Vincent Fulginiti MD, Henry Kempe MD, NIH, 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 NEJM, CDC and Logical Images, Inc. All photographs are printed with the permission of the copyright holders and may not be reproduced Post-vaccinial encephalitis is a rare complication of Frequency: Somewhat common Severity: Benign, avoid hospitalization Globulin (VIG). without the written permission of the copyright holders. primary vaccination (15/million). Encephalitis occurs Severity: Mild to severe - hospitalize severe Severity: Mild VIG: Indicated Severity: Benign (exception: recurrent generalized vaccinia - hospitalize) Copyright © by Logical Images, Inc. 10-14 days after vaccination with headache, vomiting, Frequency: Common Frequency: Unknown (exception: Stevens-Johnson Syndrome (SJS) - severe) Frequency: Rare Severity: Severe - hospitalize 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 For more information, please go to: cases life-threatening complications can develop. VIG: Not recommended for mild instances VIG: Not recommended VIG: Indicated if severe or recurrent VIG: Indicated www.bt.cdc.gov/training/smallpoxvaccine/reactions Severity: Severe - hospitalize Frequency: Rare Not recommended if mild or limited (most instances)