smallpox pre-vax training 022603.ppt

Phase 1 Pre-vaccination

Training February 26, 2003

MaineMaine

Public Health Response TeamPublic Health Response Team

Office of Public Health Emergency Preparedness

Anthony J. Tomassoni, MD, MS, FACEP, DACMTAnthony J. Tomassoni, MD, MS, FACEP, DACMTMedical DirectorMedical Director

[email protected]@Maine.gov

Steven Trockman, MPH, CHESSteven Trockman, MPH, CHESCoordinatorCoordinator


Janet AustinJanet AustinPlanning & Research Associate IIPlanning & Research Associate II


Phase 1 Pre-vaccination Objectives Explain need for public health and Explain need for public health and

hospital smallpox response teamshospital smallpox response teams

Assess smallpox vaccination risks Assess smallpox vaccination risks and screen for contraindicationsand screen for contraindications

Phase 1 Pre-vaccination Objectives Describe smallpox vaccination Describe smallpox vaccination

administration procedureadministration procedure

Define how to care for smallpox Define how to care for smallpox vaccination sitevaccination site

Identify the “take” after vaccination Identify the “take” after vaccination

Phase 1 Pre-vaccination Objectives Recognize smallpox vaccination Recognize smallpox vaccination

common and serious adverse common and serious adverse reactions reactions

Explain the procedures for reporting Explain the procedures for reporting adverse reactions and receiving care adverse reactions and receiving care

List vaccination plan next stepsList vaccination plan next steps

CDC VIDEO

SMALLPOX SMALLPOX Vaccine AdministrationVaccine Administration

37:12 minutes37:12 minutes

Need for public health and hospital smallpox response teams

Smallpox

Smallpox is a severe, febrile, contagious, Smallpox is a severe, febrile, contagious, sometimes fatal disease caused by the virus sometimes fatal disease caused by the virus “variola” that is characterized by a vesicular and “variola” that is characterized by a vesicular and pustular eruption.pustular eruption.

Why fear smallpox as BW?

Case fatality rate of 30% +Case fatality rate of 30% + No specific therapyNo specific therapy Infectious dose is smallInfectious dose is small Transmission rate of 1:10-20Transmission rate of 1:10-20

Why fear smallpox?

Used in the past as a BWUsed in the past as a BW Smallpox invokes terrorSmallpox invokes terror Weaponized; stable in aerosol formWeaponized; stable in aerosol form Worldwide vaccination ended 1980:Worldwide vaccination ended 1980:

Routine smallpox vaccination discontinued in Routine smallpox vaccination discontinued in America in 1971; not required for America in 1971; not required for international travel since 1981.international travel since 1981.

Diagnosis and Management of Smallpox NEJM 346;17:1300-1308 April 25, 2002Joel G. Breman, MD, DTPH, and D.A. Henderson, MD, MPH

Last Case of Variola Major in the World

Rahima BanuRahima Banu

Bhola Island, October 16, 1975Bhola Island, October 16, 1975

Terrorist Smallpox Event

A case of smallpox anywhere in the A case of smallpox anywhere in the worldworld

““The discovery of a single suspected The discovery of a single suspected case of smallpox must be treated as case of smallpox must be treated as an international health emergency an international health emergency and be brought immediately to the and be brought immediately to the attention of national officials through attention of national officials through local and state health authorities.”local and state health authorities.”

Consensus Statement: Smallpox as a Biological Weapon, Consensus Statement: Smallpox as a Biological Weapon, JAMAJAMA. 1999; 281: . 1999; 281: 2131.2131.

Smallpox TREATMENT

Vaccinia vaccination by the 4Vaccinia vaccination by the 4 thth day day of exposure. of exposure.

No specific anti-viral therapy No specific anti-viral therapy proven effective in clinical proven effective in clinical smallpox disease.smallpox disease.

Vistide® (cidofovir)

Cidofovir unknown Cidofovir unknown benefit against smallpoxbenefit against smallpox

Toxic side-effectsToxic side-effects

Not FDA approved for Not FDA approved for use in treatment of use in treatment of smallpoxsmallpox

ME smallpox vaccination plan

General Concepts

Vaccination targeted to Public Health Vaccination targeted to Public Health Smallpox Response Teams and hospital-Smallpox Response Teams and hospital-based Healthcare Smallpox Response based Healthcare Smallpox Response TeamsTeams

Sites established considering population Sites established considering population density, hospital clusters, judicious use of density, hospital clusters, judicious use of vaccine, vaccine security, and accessibilityvaccine, vaccine security, and accessibility

Calendar

11/21/02 Request to states for pre-event and 11/21/02 Request to states for pre-event and post-event smallpox plans due 12/9/02post-event smallpox plans due 12/9/02

12/26/02 Maine Bureau of Health invites 12/26/02 Maine Bureau of Health invites volunteers for Phase 1 - Public Health volunteers for Phase 1 - Public Health Response TeamsResponse Teams

Arrival in ME: Jan. 28

Calendar: screening

2/18/03 Smallpox volunteers receive email 2/18/03 Smallpox volunteers receive email pre-vaccination screening instructions pre-vaccination screening instructions

2/19/03 Workplace Health screening starts2/19/03 Workplace Health screening starts

VACCINE CONTRAINDICATIONS

Eczema or atopic dermatitisEczema or atopic dermatitis Active skin conditionsActive skin conditions Weakened immune systemWeakened immune system PregnancyPregnancy Eye diseaseEye disease

Serious allergic reaction to a prior dose of Serious allergic reaction to a prior dose of DryvaxDryvax®® vaccine or vaccine component vaccine or vaccine component polymyxin Bpolymyxin B streptomycinstreptomycin tetracyclinetetracycline neomycinneomycin phenolphenol



Eczema/Atopic Dermatitis:Eczema/Atopic Dermatitis: Rash involves flexures Rash involves flexures Two of the following:Two of the following:

Rash started before age 5Rash started before age 5Personal history of allergies (food/env) Personal history of allergies (food/env)

or asthmaor asthmaFirst degree relative with atopic First degree relative with atopic

dermatitisdermatitis


Allergic to the vaccineAllergic to the vaccine Younger than 12 months of ageYounger than 12 months of age Moderate or severe short-term illnessModerate or severe short-term illness Currently breastfeedingCurrently breastfeeding

Smallpox Vaccine

NYC Board of HealthNYC Board of HealthLive Vaccinia VirusLive Vaccinia Virus

DryvaxDryvax®®

Wyeth LaboratoriesWyeth Laboratories

VACCINE INDICATIONS

People who have been People who have been directly exposeddirectly exposed to the to the

smallpox virus should get the smallpox virus should get the vaccinevaccine, , regardless of their regardless of their

health statushealth status..

Vaccinia Vaccinia virus is a poxvirus. Vaccinia virus is a poxvirus.

Vaccinia is related to variola but milder.Vaccinia is related to variola but milder.

Antigenic similarity allows for cross-reactivity enabling Antigenic similarity allows for cross-reactivity enabling vaccinia vaccination to protect against smallpox.vaccinia vaccination to protect against smallpox.

Vaccinia virus may cause rash, fever, and head and body Vaccinia virus may cause rash, fever, and head and body aches. In certain groups of people, complications from aches. In certain groups of people, complications from the vaccinia virus can be severethe vaccinia virus can be severe. .

Vaccinia: “Live Virus” Vaccine

Contains a "living" virus that is able to give Contains a "living" virus that is able to give and produce immunity, usually without and produce immunity, usually without causing illnesscausing illness

Care of the site important to prevent Care of the site important to prevent transmission to other parts of the body or to transmission to other parts of the body or to other peopleother people

Live virus vaccines effective and safe for most Live virus vaccines effective and safe for most people with healthy immune systems people with healthy immune systems

Sometimes experience mild symptoms post-Sometimes experience mild symptoms post-vaccination vaccination

Other live virus vaccines: measles, mumps, Other live virus vaccines: measles, mumps, rubella, chickenpoxrubella, chickenpox

Smallpox Vaccination: Immunity

High level immunity for 3 to 5 years. High level immunity for 3 to 5 years.

Immunity wanes after 10 years. Immunity wanes after 10 years. Revaccination recommended every 10 Revaccination recommended every 10 years for continued protection.years for continued protection.

Stable antibodies during a 30-year period Stable antibodies during a 30-year period in vaccinees at birth, age 8 and 18 years.in vaccinees at birth, age 8 and 18 years.

Smallpox Vaccination: Immunity Vaccination within 3 days of exposure will Vaccination within 3 days of exposure will

prevent or significantly lessen the severity prevent or significantly lessen the severity of smallpox symptoms in the vast majority of smallpox symptoms in the vast majority of people. of people.

Vaccination 4 to 7 days after exposure Vaccination 4 to 7 days after exposure likely offers some protection from disease likely offers some protection from disease or may modify the severity of disease. or may modify the severity of disease.

Calendar: training

2/26/03 Phase 1 Pre-vaccination training (2 2/26/03 Phase 1 Pre-vaccination training (2 hours)hours)

Second session date TBD (makeup if Second session date TBD (makeup if needed) needed)

Phase 1 Vaccination

Clinics 3/3 and 3/6 (makeup/overflow)Clinics 3/3 and 3/6 (makeup/overflow)

Smallpox Vaccination Method

Multiple Puncture Vaccination Using Bifurcated NeedleMultiple Puncture Vaccination Using Bifurcated Needle

Step-by-Step Method for Vaccination

1. Skin Preparation: None.1. Skin Preparation: None.

**Under no circumstances Under no circumstances should alcohol be applied should alcohol be applied to the skin prior to to the skin prior to vaccinationvaccination * *


2. Dip Needle2. Dip NeedleThe needle is dipped into the vaccine vial and withdrawn. The needle is dipped into the vaccine vial and withdrawn. The needle is designed to hold a minute drop of vaccine of The needle is designed to hold a minute drop of vaccine of sufficient size and strength to ensure a take if properly sufficient size and strength to ensure a take if properly administered. administered.


3. Make 15 perpendicular insertions 3. Make 15 perpendicular insertions within a 5mm diameter area.within a 5mm diameter area.


4. Absorb excess vaccine.4. Absorb excess vaccine.

Cover site with sterile dressing

Virus can be recovered at site from time of Virus can be recovered at site from time of papule until scab separatespapule until scab separates

Site should be kept drySite should be kept dry Normal bathing can occur if covered by Normal bathing can occur if covered by

waterproof bandagewaterproof bandage

Vaccination Site Care

Vaccination Site Care

Cover the vaccination site loosely with a gauze Cover the vaccination site loosely with a gauze bandage.bandage.

Wear long-sleeved shirt that covers the Wear long-sleeved shirt that covers the vaccination site.vaccination site.

Change the bandage every 1-2 days. Discard Change the bandage every 1-2 days. Discard bandage waste in plastic bag with “zip” closure.bandage waste in plastic bag with “zip” closure.

Hand washing after any contact with bandage or Hand washing after any contact with bandage or sitesite

Vaccination Site CareKeep the vaccination site dry.Keep the vaccination site dry.

Put the contaminated bandages in a sealed plastic Put the contaminated bandages in a sealed plastic bag and throw them away.bag and throw them away.

Wash clothing or other any material that comes in Wash clothing or other any material that comes in contact with the vaccination site. contact with the vaccination site.

When the scab comes off, throw it away in a When the scab comes off, throw it away in a sealed plastic bag.sealed plastic bag.

Vaccination Site Care Do Do notnot use a bandage that blocks all air from the use a bandage that blocks all air from the

vaccination site. This may cause the skin at the vaccination site. This may cause the skin at the vaccination site to soften and wear away. vaccination site to soften and wear away. Use loose gauze secured with medical tape to Use loose gauze secured with medical tape to

cover the site.cover the site.

Do Do notnot put salves or ointments on the vaccination put salves or ointments on the vaccination site.site.

Do Do notnot scratch or pick at the scab. scratch or pick at the scab.

Vaccinia: Vaccination Site

““Major Reaction” (vs. “Equivocal Major Reaction” (vs. “Equivocal Reaction”)Reaction”)

First VaccinationFirst 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

WHO Expert Committee on Smallpox, 1964

Clinical Response to Vaccination

RevaccinationRevaccination Less pronounced and more rapid Less pronounced and more rapid

progressionprogression Pustular lesion or induration Pustular lesion or induration

surrounding a central crust or ulcersurrounding a central crust or ulcer

WHO Expert Committee on Smallpox, 1964

Clinical Response to Vaccination

Swelling and tenderness of axillary Swelling and tenderness of axillary lymph nodes, usually during 2lymph nodes, usually during 2ndnd week week

Fever and malaise commonFever and malaise common

Major Reaction

Normal ReactionDay 7

Normal ReactionDay 12

Major ReactionFirst time vaccinee, Day 10

Major ReactionFirst time vaccinee, Day 15

Major ReactionRevaccinee, Day 4

FatigueFatigue HeadacheHeadache MyalgiaMyalgia LymphadenopathyLymphadenopathy LymphangitisLymphangitis PruritisPruritis Edema at the vaccination siteEdema at the vaccination site Satellite LesionsSatellite Lesions

Expected Range of Vaccine Reactions

Rates of Expected Reactions

21% complications required physician consult21% complications required physician consult Most Common SymptomsMost Common Symptoms

Fatigue (50%)Fatigue (50%) Headache (40%)Headache (40%) Muscle aches and Chills (20%)Muscle aches and Chills (20%) Nausea (20%)Nausea (20%) Fever Fever 37.7 37.7 ºC or 100 ºF (10%)ºC or 100 ºF (10%)

Administrative Leave

Do not need to place HCWs on leave, Do not need to place HCWs on leave, unless:unless: Physically unable to work due to Physically unable to work due to

systemic signs and symptomssystemic signs and symptoms Extensive skin lesions or vaccination site Extensive skin lesions or vaccination site

that can not be coveredthat can not be covered HCWs do not adhere to infection control HCWs do not adhere to infection control

precautions and recommendationsprecautions and recommendations

MMWR: Feb 21, 2001/52(02):136

n = 4,213 health-care workers in 27 different cities and counties

7 (~ 0.17 %) nonserious adverse events include: fever (2), rash (2), malaise (2), pruritus (2), hypertension (2) and pharyngitis (2)

US Military Data as of 2/12/03

DoD healthcare workers vaccinated against DoD healthcare workers vaccinated against smallpox: More than 8,000smallpox: More than 8,000

DoD operational forces vaccinated against DoD operational forces vaccinated against smallpox: Well over 100,000smallpox: Well over 100,000

US Military Data as of 2/12/03

Sick Leave (SL) OverallSick Leave (SL) Overall 3% of vaccinated People3% of vaccinated People

- - SL after primary (first)SL after primary (first) 4-5%4-5%

- - SL after revaccinationSL after revaccination 1% to 2%1% to 2%

- Average length of sick - Average length of sick leaveleave

1.5 days1.5 days

Auto-inoculationAuto-inoculation 1 case1 case

Transfer of vaccinia virus to Transfer of vaccinia virus to contactscontacts

0 cases0 cases

Treatments with (VIG)Treatments with (VIG) 0 cases0 cases

Deaths due to smallpox Deaths due to smallpox vaccinationvaccination

0 cases0 cases

Smallpox Vaccine Adverse Reactions

Nonspecific dermatological conditions Nonspecific dermatological conditions Inadvertent inoculationInadvertent inoculation Ocular vacciniaOcular vaccinia Generalized vacciniaGeneralized vaccinia Eczema vaccinatumEczema vaccinatum Progressive vaccinia (vaccinia necrosum)Progressive vaccinia (vaccinia necrosum) Post-vaccinial encephalitisPost-vaccinial encephalitis Fetal vacciniaFetal vaccinia Other Other Not yet characterizedNot yet characterized

Vaccinia: Adverse Reactions

The most frequent adverse The most frequent adverse complication of vaccination is complication of vaccination is inadvertent inoculationinadvertent inoculation at other at other

sites.sites.

Inadvertent Inoculation

Transfer of vaccinia virus from vaccination site Transfer of vaccinia virus from vaccination site to another site on the body, or to a close contactto another site on the body, or to a close contact

Most frequent complication of smallpox Most frequent complication of smallpox vaccinationvaccination

Most common sites are periocular/ocular, face, Most common sites are periocular/ocular, face, nose, mouth, genitalia, rectumnose, mouth, genitalia, rectum

Lesions contain vaccinia virus and follow Lesions contain vaccinia virus and follow vaccination coursevaccination course

Adverse Vaccination Reactions

Accidental ImplantationAccidental Implantation

Inadvertent Inoculation

Hand washing after contact with vaccination Hand washing after contact with vaccination site or contaminated material most effective site or contaminated material most effective preventionprevention

Uncomplicated lesions require no therapy, self-Uncomplicated lesions require no therapy, self-limited, resolve in ~3 weekslimited, resolve in ~3 weeks Risk factors: disruption of epidermis or very Risk factors: disruption of epidermis or very

youngyoung

VIG may speed recovery if extensive or severe VIG may speed recovery if extensive or severe manifestation (e.g., significant pain) manifestation (e.g., significant pain)

Nonspecific rash following smallpox vaccination

Vaccination site

Photo credit: J. Michael Lane, MD MPHCDC Teaching slide set

Adverse reactions following smallpox vaccination

Nonspecific Rashes

Flat, erythematous, macules or patches, and Flat, erythematous, macules or patches, and generalized urticarial rashes generalized urticarial rashes

Usually do not become vesicularUsually do not become vesicular Onset ~ 10 days post-vaccinationOnset ~ 10 days post-vaccination Afebrile patient, well appearing Afebrile patient, well appearing Spontaneously resolves ~2-4 daysSpontaneously resolves ~2-4 days Immune response vs. viral replicationImmune response vs. viral replication Antipruritics Antipruritics

Nonspecific rash following smallpox vaccination

Photo credit: Vaccination reactions in vaccinia-naive volunteers in a clinical study of diluted Dryvax® enrolled in NIAID VTEUs

Photo credit: V. Fulginiti, MD and Logical Imageshttp://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm

ERYTHEMA MULTIFORME


Auto-inoculationAuto-inoculation

Ocular Vaccinia May present as blepharitis, conjunctivitis, May present as blepharitis, conjunctivitis,

keratitis, iritis, or combinationkeratitis, iritis, or combination

Should be managed in consultation with an Should be managed in consultation with an ophthalmologistophthalmologist

Treatment may include topical ophthalmic Treatment may include topical ophthalmic topical antiviral agents, topical steroids topical antiviral agents, topical steroids and topical antibacterials and VIGand topical antibacterials and VIG

Secondary Corneal Infection


Vaccinia KeratitisVaccinia Keratitis


Bacterial InfectionsBacterial Infections


Generalized VacciniaGeneralized Vaccinia

Vaccination site

Regional form

Sometimes resemblesSmallpox

Photo credit: J. Michael Lane, MD MPHCDC Teaching slide set

Adverse reactions following smallpox vaccination

GENERALIZED VACCINIA


Generalized vacciniaGeneralized vaccinia


Eczema VaccinatumEczema Vaccinatum

Multiple umbilicated EV papular lesionsHealed EV

EV predilection for sites of atopic dermatitis (eczema)

Photo credit: V. Fulginiti, MD, H. Kempe MD and Logical Imageshttp://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm


Eczema vaccinatumEczema vaccinatum


Progressive VacciniaProgressive Vaccinia

““Vaccinia Necrosum/Gangrenosa”Vaccinia Necrosum/Gangrenosa”

““Disseminated Vaccinia”Disseminated Vaccinia”


Progressive VacciniaProgressive Vaccinia

Photo credit: J. Michael Lane, MD MPHCDC Teaching slide set Adverse reactions

following smallpox vaccination

Atypical PV in 64yo with lymphoma and

IgA, IgM and IgA deficiency

Severe Take

Severe take

Progressive vacciniaPhoto credit: V. Fulginiti, MD and Logical Images

http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm

SCID

HypogammaglobulinemiaLymphosarcoma

Lymphoma and PV

FETAL VACCINIAPhoto credit: J. Michael Lane, MD MPH

CDC Teaching slide set Adverse reactions following smallpox vaccination

Fetal vaccinia

Photo credit: J. Michael Lane, MD MPHCDC Teaching slide set Adverse reactions

following smallpox vaccination

Post-vaccination Responsibilities

Careful care of your siteCareful care of your site Stay hydrated – drink fluidsStay hydrated – drink fluids

Adverse reactions:Adverse reactions: Call to reportCall to report Follow-up with your primary care physicianFollow-up with your primary care physician Emergency care if neededEmergency care if needed

Reporting Adverse Events Following Smallpox Vaccine Report – clinically significant or unexpected AesReport – clinically significant or unexpected Aes

When – clinically significant/unexpected AEs within 48 When – clinically significant/unexpected AEs within 48 hours and other AEs within 7 dayshours and other AEs within 7 days

Who can report – SHDs, providers, vaccinees, Who can report – SHDs, providers, vaccinees, manufacturersmanufacturers

How to reportHow to report http://secure.vaers.org/VaersDataEntry.cfmhttp://secure.vaers.org/VaersDataEntry.cfm Fax: 877-721-0366Fax: 877-721-0366 Telephone: 800-822-7967 for formTelephone: 800-822-7967 for form

Next steps

Voluntary program: determine your risk Voluntary program: determine your risk

Vaccination clinics next weekVaccination clinics next week

Post-vaccination training Post-vaccination training Phase 2 vaccinationsPhase 2 vaccinations Prepared for mass vaccination (if event)Prepared for mass vaccination (if event)

Calendar: Vaccination clinics

3/3 Vaccination clinic 13/3 Vaccination clinic 1 3/10 Check “takes” (day 7 clinic 1)3/10 Check “takes” (day 7 clinic 1)

3/6 Vaccination clinic 2 (makeup/overflow)3/6 Vaccination clinic 2 (makeup/overflow) 3/13 Check “takes” (day 7 clinic 2)3/13 Check “takes” (day 7 clinic 2)

Calendar: Post-vax training

Phase 1 Post-vaccination training (6 Phase 1 Post-vaccination training (6 hours) on 3/20hours) on 3/20

Identify and prioritize roles of public Identify and prioritize roles of public health response team member:health response team member:

In event of smallpox In event of smallpox exposure event: (4 hours)exposure event: (4 hours)

As member of vaccination team: As member of vaccination team: (two 1-hour workshops)(two 1-hour workshops)

Calendar: Phase 2 schedule

To be determinedTo be determined

For More Information

CDC Smallpox websiteCDC Smallpox website

www.cdc.gov/smallpoxwww.cdc.gov/smallpox

National Immunization Program website National Immunization Program website www.cdc.gov/nipwww.cdc.gov/nip

Acknowledgements: sources for slides and materials

Anthony J. Carbone, MD, MS, MPH Anthony J. Carbone, MD, MS, MPH The Harvard Center For Public Health PreparednessThe Harvard Center For Public Health Preparedness

Harvard School of Public HealthHarvard School of Public Health

Centers for Disease Control and PreventionCenters for Disease Control and PreventionCertain images supplied by:

Dr. J. Michael LaneDr. Vincent Fulginiti

Dr. Henry KempeDr. John Leedom

NEJMNational Institutes of Health

Logical Images, Inc.

Acknowledgements:

Anthony J. Tomassoni, MD, MS, FACEP, DACMTAnthony J. Tomassoni, MD, MS, FACEP, DACMTMedical DirectorMedical Director

OPHEPOPHEP

Jo E. Linder, MDJo E. Linder, MDMedical Officer, Southern RegionMedical Officer, Southern Region

HHSD/Portland Public HealthHHSD/Portland Public Health

Thank You for Volunteering!

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