Smallpox Vaccine: Smallpox Vaccine: Overview for Health Care Overview for Health Care Response Teams Response Teams Thomas G. Franck, MD, MPH Thomas G. Franck, MD, MPH Regional Physician Consultant Regional Physician Consultant Office of Emergency Preparedness & Office of Emergency Preparedness & Response Response Virginia Department of Health Virginia Department of Health January 2003 January 2003
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Smallpox Vaccine: Overview for Health Care Response Teams Thomas G. Franck, MD, MPH Regional Physician Consultant Office of Emergency Preparedness & Response.
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Smallpox Vaccine:Smallpox Vaccine:
Overview for Health Care Overview for Health Care Response TeamsResponse Teams
Thomas G. Franck, MD, MPHThomas G. Franck, MD, MPHRegional Physician ConsultantRegional Physician Consultant
Office of Emergency Preparedness & ResponseOffice of Emergency Preparedness & Response
Virginia Department of HealthVirginia Department of Health
January 2003January 2003
ObjectivesObjectives
To briefly review smallpox diseaseTo briefly review smallpox disease To gain an in depth understanding To gain an in depth understanding
of smallpox vaccine, including:of smallpox vaccine, including:– history of smallpox vaccinationhistory of smallpox vaccination– overview of vacciniaoverview of vaccinia– indicationsindications– contraindicationscontraindications– normal responsenormal response– complicationscomplications
– Vaccination - protective if given Vaccination - protective if given within 3 days of exposurewithin 3 days of exposure
Smallpox:Smallpox:Why the Concern Now? Why the Concern Now?
Last case in US in 1949Last case in US in 1949 Last naturally acquired case in 1977Last naturally acquired case in 1977 Disease declared eliminated by WHO in 1980Disease declared eliminated by WHO in 1980 Stocks of Variola virus held by U.S. & RussiaStocks of Variola virus held by U.S. & Russia Bio Weapons programs in several countries Bio Weapons programs in several countries Recent Intelligence review: 4 countries may Recent Intelligence review: 4 countries may
have covert stocks of smallpox virus – Russia, have covert stocks of smallpox virus – Russia, Iraq, North Korea, and FranceIraq, North Korea, and France
Live virus called “Vaccinia”Live virus called “Vaccinia”
An orthopoxvirus, genetically distinct An orthopoxvirus, genetically distinct from other orthopoxviruses such as from other orthopoxviruses such as cowpox, monkeypox, and variola (cause cowpox, monkeypox, and variola (cause of smallpox)of smallpox)
Origin unknown: May be a virus now Origin unknown: May be a virus now extinct in natureextinct in nature
Contains NY City Board of Health strainContains NY City Board of Health strain
2.7 million doses licensed (phase 1)*2.7 million doses licensed (phase 1)*
Enough vaccine “to vaccinate every single Enough vaccine “to vaccinate every single person in the country in an emergency”*person in the country in an emergency”*
Reduces chance of getting infected Reduces chance of getting infected (i.e., decreases secondary attack (i.e., decreases secondary attack rate)rate) 91%-97% reduction in cases among 91%-97% reduction in cases among
case contacts with vaccination scarcase contacts with vaccination scar
For those infected, reduces fatality For those infected, reduces fatality rate and severity of diseaserate and severity of disease
Mack, J. Inf Dis, 1972
Vaccine Efficacy:Vaccine Efficacy:Post Exposure Post Exposure
Generally prevents smallpox, or Generally prevents smallpox, or significantly decreases severity, significantly decreases severity, if if given within 3 days of exposuregiven within 3 days of exposure
Vaccination 4 to 7 days post-Vaccination 4 to 7 days post-exposureexposurestill offered protection to many still offered protection to many people, but significantly less than people, but significantly less than vaccination before 4 daysvaccination before 4 days
High level of protection (95-100%) for 3-5 High level of protection (95-100%) for 3-5 years following vaccinationyears following vaccination
Immunity wanes after 5 years, but some Immunity wanes after 5 years, but some residual protection evident at 10 and even residual protection evident at 10 and even 20+ years20+ years
Reduction in disease severity with any Reduction in disease severity with any history of vaccinationhistory of vaccination
However, best protection if vaccinated <3-5 However, best protection if vaccinated <3-5 yrs ago; yrs ago; we cannot rely on previous we cannot rely on previous vaccinations to protect our population and vaccinations to protect our population and we should consider the population to lack we should consider the population to lack immunity to smallpox.immunity to smallpox.
Current Indications:Current Indications:– Laboratory workers who handle cultures or Laboratory workers who handle cultures or
animals infected with non-highly attenuated animals infected with non-highly attenuated vaccinia or other Orthopoxvirusesvaccinia or other Orthopoxviruses
New Recommendations:New Recommendations:– Public health, hospital, and other personnel, Public health, hospital, and other personnel,
generally 18-65 years of age, who may have generally 18-65 years of age, who may have to respond to a smallpox case or outbreakto respond to a smallpox case or outbreak
Ring VaccinationRing Vaccination– Persons exposed to initial releasePersons exposed to initial release– Close contact with confirmed or suspected Close contact with confirmed or suspected
casecase– Direct care or transportation of confirmed or Direct care or transportation of confirmed or
suspected casesuspected case– Laboratory personnelLaboratory personnel– Persons with risk of contact with infectious Persons with risk of contact with infectious
materials from casematerials from case Mass Vaccination of entire populations?Mass Vaccination of entire populations?
Eczema/atopic dermatitis (active or history of) or Eczema/atopic dermatitis (active or history of) or household contact with eczema/atopic dermatitishousehold contact with eczema/atopic dermatitis
Other active skin conditions (allergic rash, burns, Other active skin conditions (allergic rash, burns, impetigo, chickenpox, shingles, herpes,psoriasis, impetigo, chickenpox, shingles, herpes,psoriasis, severe acne, etc.) or household contact with acitve severe acne, etc.) or household contact with acitve skin conditionskin condition
Immunosuppression or household contact with Immunosuppression or household contact with immunosuppressionimmunosuppression
Pregnancy or pregnant household contactPregnancy or pregnant household contact
BreastfeedingBreastfeeding Infants (not advised in children < 18)Infants (not advised in children < 18) Severe allergic reaction to prior vaccination or Severe allergic reaction to prior vaccination or
Conditions causing immunodeficiency:Conditions causing immunodeficiency:– HIV, leukemia, lymphoma, other cancers, HIV, leukemia, lymphoma, other cancers,
agammaglobulinemia, certain autoimmune agammaglobulinemia, certain autoimmune disorders (e.g., SLE), other immune disorders (e.g., SLE), other immune disordersdisorders
Contraindications: Contraindications: Eczema/Atopic Eczema/Atopic DermatitisDermatitis Eczema:Eczema: a red, itchy rash that lasts a red, itchy rash that lasts
at least two weeks and then comes at least two weeks and then comes and goesand goes
It is estimated that at least 15 It is estimated that at least 15 million people in U.S. have atopic million people in U.S. have atopic dermatitisdermatitis
These people are at risk of a serious These people are at risk of a serious complication, eczema vaccinatumcomplication, eczema vaccinatum
Exposed persons – no Exposed persons – no contraindicationscontraindications
Unexposed persons – generally same Unexposed persons – generally same as non-emergency situations w/ some as non-emergency situations w/ some modifications, depending on situationmodifications, depending on situation
Remember – Remember – live vaccinia viruslive vaccinia virus is is present at site of vaccination until present at site of vaccination until scab falls off on its own, usually 2-3 scab falls off on its own, usually 2-3 weeks.weeks.
DressingDressingHealth care setting: 3 layers of protection Health care setting: 3 layers of protection
– gauze, semipermeable dressing, shirt– gauze, semipermeable dressing, shirtNon-health care setting: 2 layers of Non-health care setting: 2 layers of
protection – gauze & shirtprotection – gauze & shirt Avoid salves and ointmentsAvoid salves and ointments Avoid touching/scratching site and Avoid touching/scratching site and
Semipermeable dressing: change Semipermeable dressing: change dressing at least every 3-5 days and as dressing at least every 3-5 days and as neededneeded
Gauze dressing secured by tape: change Gauze dressing secured by tape: change dressing every 1-3 days and as neededdressing every 1-3 days and as needed
““Take” evaluation: 7 days after Take” evaluation: 7 days after vaccination (+/- 1 day)vaccination (+/- 1 day)
If significant side effects or adverse If significant side effects or adverse event, follow-up with designated health event, follow-up with designated health care providercare provider
Clinical Response to Clinical Response to Vaccination* Vaccination*
Sign/symptomPapuleVesiclePustule
Maximum erythemaScab
Scab separation
Time after Vacc3 days
5-6 days7-11 days8-12 days14 days21 days
*typical response in a nonimmune person
Clinical Response to Clinical Response to Vaccination Vaccination
Major (primary) reactionMajor (primary) reaction– Indicates viral replication has Indicates viral replication has
occurred and vaccination was occurred and vaccination was successfulsuccessful
No reaction or equivocal reactionNo reaction or equivocal reaction– No immunity and vaccination must be No immunity and vaccination must be
repeatedrepeated
Major Reaction*Major Reaction*(6-8 days after (6-8 days after vaccination) vaccination)
Primary vaccinationPrimary vaccination– Vesicular or pustular lesionVesicular or pustular lesion– Area of definite palpable induration Area of definite palpable induration
surrounding a central crust or ulcersurrounding a central crust or ulcer RevaccinationRevaccination
– Less pronounced and more rapid Less pronounced and more rapid progressionprogression
– Pustular lesion or induration surrounding Pustular lesion or induration surrounding a central crust or ulcera central crust or ulcer*WHO Expert Committee on Smallpox,
1964
Day 3
Primary Revaccination
Day 7
Primary Revaccination
Day 10
Primary Revaccination
Day 14
Primary Revaccination
Normal Variants:Normal Variants:Satellite LesionsSatellite Lesions
Normal Variants:Normal Variants:Cellulitis & Cellulitis & LymphangitisLymphangitis
Smallpox Vaccination:Smallpox Vaccination:Normal Side EffectsNormal Side Effects
Fever: 10% of adultsFever: 10% of adults Localized soreness: 35-47%Localized soreness: 35-47% Headache/muscle aches: 40-50%Headache/muscle aches: 40-50% Redness/swelling > 3 inches: 15% Redness/swelling > 3 inches: 15% 1/3 may feel bad enough to miss 1/3 may feel bad enough to miss
work, school, activity, or have work, school, activity, or have trouble sleepingtrouble sleeping
Contact transmission: spread vaccinia to others Contact transmission: spread vaccinia to others Inadvertent autoinoculation: spread to other Inadvertent autoinoculation: spread to other
sites on bodysites on body Generalized vaccinia: spread throughout bodyGeneralized vaccinia: spread throughout body Eczema vaccinatum: severe skin reactionEczema vaccinatum: severe skin reaction Progressive vaccinia (vaccinia necrosum)Progressive vaccinia (vaccinia necrosum) Postvaccinial encephalitisPostvaccinial encephalitis DeathDeath
Accidental InoculationAccidental Inoculation
Accidental auto-inoculation of cheek with vaccinia virus, approximately 5 days old. Primary take on arm, 10-12 days old. Photo courtesy of John M. Leedom, MD.
Accidental InoculationAccidental Inoculation
Generalized VacciniaGeneralized Vaccinia
Generalized vaccinia in an apparently normal child. Recovered without sequelae. Photo courtesy of John M. Leedom, M.D.
Generalized VacciniaGeneralized Vaccinia
Eczema VaccinatumEczema Vaccinatum
Eczema VaccinatumEczema Vaccinatum
Progressive VacciniaProgressive Vaccinia
Post-Vaccinial Post-Vaccinial EncephalitisEncephalitis Autoimmune process Autoimmune process No predictors of susceptibility No predictors of susceptibility Supportive care; no specific therapy Supportive care; no specific therapy Vaccinia Immune Globulin is not Vaccinia Immune Globulin is not
effective and is effective and is not recommendednot recommended. . 15-25% mortality; and 25% had permanent neurological
sequelae
Vaccinia Keratitis
Vaccine Adverse Vaccine Adverse EventsEvents
ComplicationComplication # per # per millionmillion
Indicated:Indicated:– Eczema vaccinatumEczema vaccinatum– Progressive vacciniaProgressive vaccinia– Generalized vaccinia (if severe or recurrent)Generalized vaccinia (if severe or recurrent)– Accidental implantation (ocular or extensive Accidental implantation (ocular or extensive
lesions)lesions) Not Recommended:Not Recommended:
– Accidental implantation (mild instances)Accidental implantation (mild instances)– Generalized vaccinia (mild or limited - most Generalized vaccinia (mild or limited - most
“…it now becomes too manifest to admit of controversy, that the annihilation of the Small Pox, the most dreadful scourge of the human species, must be the final result of this practice.”