Phase 1 Prevaccination Training February 26, 2003

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Phase 1 Pre-vaccinationTraining February 26,
2003

• Maine
• Public Health Response Team

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Office of Public Health Emergency Preparedness

• Anthony J. Tomassoni, MD, MS, FACEP, DACMT
• Medical Director
• 287.7312
• Anthony.Tomassoni_at_Maine.gov
• Steven Trockman, MPH, CHES
• Coordinator
• 287.8104
• Steven.Trockman_at_Maine.gov
• Janet Austin
• Planning Research Associate II
• 287.7310
• Janet.Austin_at_Maine.gov

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Phase 1 Pre-vaccination Objectives

• Explain need for public health and hospital
  smallpox response teams
• Assess smallpox vaccination risks and screen for
  contraindications

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Phase 1 Pre-vaccination Objectives

• Describe smallpox vaccination administration
  procedure
• Define how to care for smallpox vaccination site
• Identify the take after vaccination

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Phase 1 Pre-vaccination Objectives

• Recognize smallpox vaccination common and serious
  adverse reactions
• Explain the procedures for reporting adverse
  reactions and receiving care
• List vaccination plan next steps

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CDC VIDEO

• SMALLPOX Vaccine Administration
• 3712 minutes

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Need for public health and hospital smallpox
response teams
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Smallpox

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

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Why fear smallpox as BW?

• Case fatality rate of 30
• No specific therapy
• Infectious dose is small
• Transmission rate of 110-20

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Why fear smallpox?

• Used in the past as a BW
• Smallpox invokes terror
• Weaponized stable in aerosol form
• Worldwide vaccination ended 1980
• Routine smallpox vaccination discontinued in
  America in 1971 not required for international
  travel since 1981.

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BIOPREPARAT (USSR)

• Began producing smallpox in large quantities in
  1980.
• Capable of producing several tons of variola
  annually.
• Militarized smallpox for use in bombs, ICBMs, and
  cruise missiles.
• Researching more virulent and contagious
  recombinant strains of variola.

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Iraqi BW Program
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Diagnosis and Management of Smallpox NEJM
346171300-1308 April 25, 2002 Joel G. Breman,
MD, DTPH, and D.A. Henderson, MD, MPH
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Last Case of Variola Major in the World

• Rahima Banu
• Bhola Island, October 16, 1975

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Terrorist Smallpox Event

• A case of smallpox anywhere in the world
• The discovery of a single suspected case of
  smallpox must be treated as an international
  health emergency and be brought immediately to
  the attention of national officials through local
  and state health authorities.
• Consensus Statement Smallpox as a Biological
  Weapon, JAMA. 1999 281 2131.

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Smallpox TREATMENT

• Vaccinia vaccination by the 4th day of exposure.
• No specific anti-viral therapy proven effective
  in clinical smallpox disease.

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Vistide (cidofovir)

• Cidofovir unknown benefit against smallpox
• Toxic side-effects
• Not FDA approved for use in treatment of
  smallpox

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ME smallpox vaccination plan
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General Concepts

• Vaccination targeted to Public Health Smallpox
  Response Teams and hospital-based Healthcare
  Smallpox Response Teams
• Sites established considering population density,
  hospital clusters, judicious use of vaccine,
  vaccine security, and accessibility

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Calendar

• 11/21/02 Request to states for pre-event and
  post-event smallpox plans due 12/9/02
• 12/26/02 Maine Bureau of Health invites
  volunteers for Phase 1 - Public Health Response
  Teams

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Arrival in ME Jan. 28
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Calendar screening

• 2/18/03 Smallpox volunteers receive email
  pre-vaccination screening instructions
• 2/19/03 Workplace Health screening starts

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VACCINE CONTRAINDICATIONS

• Eczema or atopic dermatitis
• Active skin conditions
• Weakened immune system
• Pregnancy
• Eye disease

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VACCINE CONTRAINDICATIONS

• Serious allergic reaction to a prior dose of
  Dryvax vaccine or vaccine component
• polymyxin B
• streptomycin
• tetracycline
• neomycin
• phenol

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VACCINE CONTRAINDICATIONS

• Eczema/Atopic Dermatitis
• Rash involves flexures
• Two of the following
• Rash started before age 5
• Personal history of allergies (food/env) or
  asthma
• First degree relative with atopic dermatitis

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VACCINE CONTRAINDICATIONS

• Allergic to the vaccine
• Younger than 12 months of age
• Moderate or severe short-term illness
• Currently breastfeeding

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Smallpox Vaccine

• NYC Board of Health
• Live Vaccinia Virus
• Dryvax
• Wyeth Laboratories

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VACCINE INDICATIONS

• People who have been directly exposed to the
  smallpox virus should get the vaccine, regardless
  of their health status.

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Vaccinia

• Vaccinia virus is a poxvirus.
• Vaccinia is related to variola but milder.
• Antigenic similarity allows for cross-reactivity
  enabling vaccinia vaccination to protect against
  smallpox.
• Vaccinia virus may cause rash, fever, and head
  and body aches. In certain groups of people,
  complications from the vaccinia virus can be
  severe.

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Vaccinia Live Virus Vaccine

• Contains a "living" virus that is able to give
  and produce immunity, usually without causing
  illness
• Care of the site important to prevent
  transmission to other parts of the body or to
  other people
• Live virus vaccines effective and safe for most
  people with healthy immune systems
• Sometimes experience mild symptoms
  post-vaccination
• Other live virus vaccines measles, mumps,
  rubella, chickenpox

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Smallpox Vaccination Immunity

• High level immunity for 3 to 5 years.
• Immunity wanes after 10 years. Revaccination
  recommended every 10 years for continued
  protection.
• Stable antibodies during a 30-year period in
  vaccinees at birth, age 8 and 18 years.

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Smallpox Vaccination Immunity

• Vaccination within 3 days of exposure will
  prevent or significantly lessen the severity of
  smallpox symptoms in the vast majority of people.
  
• Vaccination 4 to 7 days after exposure likely
  offers some protection from disease or may modify
  the severity of disease.

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Calendar training

• 2/26/03 Phase 1 Pre-vaccination training (2
  hours)
• Second session date TBD (makeup if needed)

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Phase 1 Vaccination

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

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Smallpox Vaccination Method

• Multiple Puncture Vaccination Using Bifurcated
  Needle

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Step-by-Step Method for Vaccination

• 1. Skin Preparation None.
• Under no circumstances should alcohol be
  applied to the skin prior to vaccination

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Step-by-Step Method for Vaccination

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

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Step-by-Step Method for Vaccination

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

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Step-by-Step Method for Vaccination

• 4. Absorb excess vaccine.

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Cover site with sterile dressing
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Vaccination Site Care

• Virus can be recovered at site from time of
  papule until scab separates
• Site should be kept dry
• Normal bathing can occur if covered by waterproof
  bandage

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Vaccination Site Care

• Cover the vaccination site loosely with a gauze
  bandage.
• Wear long-sleeved shirt that covers the
  vaccination site.
• Change the bandage every 1-2 days. Discard
  bandage waste in plastic bag with zip closure.
• Hand washing after any contact with bandage or
  site

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Vaccination Site Care

• Keep the vaccination site dry.
• Put the contaminated bandages in a sealed plastic
  bag and throw them away.
• Wash clothing or other any material that comes in
  contact with the vaccination site.
• When the scab comes off, throw it away in a
  sealed plastic bag.

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Vaccination Site Care

• Do not use a bandage that blocks all air from the
  vaccination site. This may cause the skin at the
  vaccination site to soften and wear away.
• Use loose gauze secured with medical tape to
  cover the site.
• Do not put salves or ointments on the vaccination
  site.
• Do not scratch or pick at the scab.

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Vaccinia Vaccination Site

• Major Reaction (vs. Equivocal Reaction)

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Clinical Response to Vaccination

• First Vaccination
• Vesicular or pustular lesion
• Area of definite palpable induration surrounding
  a central crust or ulcer

WHO Expert Committee on Smallpox, 1964
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Clinical Response to Vaccination

• Revaccination
• Less pronounced and more rapid progression
• Pustular lesion or induration surrounding a
  central crust or ulcer

WHO Expert Committee on Smallpox, 1964
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Major Reaction

• Swelling and tenderness of axillary lymph nodes,
  usually during 2nd week
• Fever and malaise common

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(No Transcript)
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Normal ReactionDay 7
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Normal ReactionDay 12
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Major ReactionFirst time vaccinee, Day 10
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Major ReactionFirst time vaccinee, Day 15
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Major ReactionRevaccinee, Day 4
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Major ReactionRevaccinee, Day 8
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Major ReactionRevaccinee, Day 10
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Major ReactionRevaccinee, Day 15
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Expected Range of Vaccine Reactions

• Fatigue
• Headache
• Myalgia
• Lymphadenopathy
• Lymphangitis
• Pruritis
• Edema at the vaccination site
• Satellite Lesions

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Rates of Expected Reactions

• 21 complications required physician consult
• Most Common Symptoms
• Fatigue (50)
• Headache (40)
• Muscle aches and Chills (20)
• Nausea (20)
• Fever ? 37.7 ºC or 100 ºF (10)

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Administrative Leave

• Do not need to place HCWs on leave, unless
• Physically unable to work due to systemic signs
  and symptoms
• Extensive skin lesions or vaccination site that
  can not be covered
• HCWs do not adhere to infection control
  precautions and recommendations

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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)
MMWR Feb 21, 2001/52(02)136
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US Military Data as of 2/12/03

• DoD healthcare workers vaccinated against
  smallpox More than 8,000
• DoD operational forces vaccinated against
  smallpox Well over 100,000

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US Military Data as of 2/12/03
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Smallpox Vaccine Adverse Reactions

• Nonspecific dermatological conditions
• Inadvertent inoculation
• Ocular vaccinia
• Generalized vaccinia
• Eczema vaccinatum
• Progressive vaccinia (vaccinia necrosum)
• Post-vaccinial encephalitis
• Fetal vaccinia
• Other
• Not yet characterized

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Vaccinia Adverse Reactions

• The most frequent adverse complication of
  vaccination is inadvertent inoculation at other
  sites.

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Inadvertent Inoculation

• Transfer of vaccinia virus from vaccination site
  to another site on the body, or to a close
  contact
• Most frequent complication of smallpox
  vaccination
• Most common sites are periocular/ocular, face,
  nose, mouth, genitalia, rectum
• Lesions contain vaccinia virus and follow
  vaccination course

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Adverse Vaccination Reactions

• Accidental Implantation

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Inadvertent Inoculation

• Hand washing after contact with vaccination site
  or contaminated material most effective
  prevention
• Uncomplicated lesions require no therapy,
  self-limited, resolve in 3 weeks
• Risk factors disruption of epidermis or very
  young
• VIG may speed recovery if extensive or severe
  manifestation (e.g., significant pain)

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Vaccination site
Nonspecific rash following smallpox vaccination
Photo credit J. Michael Lane, MD MPH CDC
Teaching slide set Adverse reactions following
smallpox vaccination
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Nonspecific Rashes

• Flat, erythematous, macules or patches, and
  generalized urticarial rashes
• Usually do not become vesicular
• Onset 10 days post-vaccination
• Afebrile patient, well appearing
• Spontaneously resolves 2-4 days
• Immune response vs. viral replication
• Antipruritics

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Nonspecific rash following smallpox vaccination
Photo credit Vaccination reactions in
vaccinia-naive volunteers in a clinical study of
diluted Dryvax enrolled in NIAID VTEUs
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ERYTHEMA MULTIFORME
Photo credit V. Fulginiti, MD and Logical
Images http//www.bt.cdc.gov/training/smallpoxvacc
ine/reactions/default.htm
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Erythema Multiforme

• Variety of lesions include macules, papules,
  urticaria, and typical bulls-eye (targetoid)
  lesions
• Central, dark papule, surrounded by pale zone and
  a halo of erythema
• Course is extrapolated from other infectious
  agents (HSV, mycoplasma)
• 10 days after vaccination
• Occasional Stevens-Johnson syndrome
• gt2 mucosal surfaces / 10 BSA

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Erythema Multiforme and Stevens Johnson Syndrome

• Hypersensitivity reactions
• Lesions are not thought to contain virus
• Antipruritics
• VIG not indicated
• Supportive care (hospitalize for SJS)
• Role of steroids in SJS controversial
• Consult immunologist, dermatologist, or
  infectious disease specialist

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Adverse Vaccination Reactions

• Auto-inoculation

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Ocular Vaccinia

• May present as blepharitis, conjunctivitis,
  keratitis, iritis, or combination
• Should be managed in consultation with an
  ophthalmologist
• Treatment may include topical ophthalmic topical
  antiviral agents, topical steroids and topical
  antibacterials and VIG

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Secondary Corneal Infection
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Adverse Vaccination Reactions

• Vaccinia Keratitis

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Adverse Vaccination Reactions

• Bacterial Infections

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Adverse Vaccination Reactions

• Generalized Vaccinia

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Generalized Vaccinia

• Differential diagnosis
• Erythema multiforme
• Eczema vaccinatum
• Inadvertent inoculation at multiple sites
• Early progressive vaccinia
• Disseminated herpes
• Severe varicella

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GENERALIZED VACCINIA
Vaccination site
Photo credit J. Michael Lane, MD MPH CDC
Teaching slide set Adverse reactions following
smallpox vaccination
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Generalized Vaccinia

• Generally self-limited in immunocompetent hosts
• Most cases do not require therapy
• VIG may be considered for severe disease or
  underlying illness
• Thought to be due to viremia
• Lesions contain vaccinia use infection control
  precautions

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Adverse Vaccination Reactions

• Generalized vaccinia

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Eczema Vaccinatum

• Predilection for site of atopic dermatitis
  (eczema) eruptions
• Severity independent of the activity of the
  underlying eczema
• In contacts onset 5-19 days following suspected
  exposure
• Severe cases among contacts of recently
  vaccinated person

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Adverse Vaccination Reactions

• Eczema Vaccinatum

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Eczema Vaccinatum

• Localized or generalized papular, vesicular or
  pustular rash
• Onset concurrent or shortly after vaccinial
  lesion at vaccination site
• Lesions follow same course as vaccination site,
  may be confluent with/without umbilication
• Fever, lymphadenopathy and systemically ill

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Photo credit V. Fulginiti, MD, H. Kempe MD and
Logical Images http//www.bt.cdc.gov/training/smal
lpoxvaccine/reactions/default.htm
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Adverse Vaccination Reactions

• Eczema vaccinatum

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Adverse Vaccination Reactions

• Progressive Vaccinia
• Vaccinia Necrosum/Gangrenosa
• Disseminated Vaccinia

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Adverse Vaccination Reactions

• Progressive Vaccinia

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Evolution of Progressive Vaccinia

• Primary vaccination site does not heal.
• Lesion is ulcerative or visiculo-pustular with
  central necrosis.
• Lesion expands circumferentially with extensive
  necrosis.
• Viremic or secondary inoculation lesions undergo
  same evolution with massive involvement.

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Evolution of Progressive Vaccinia

• Coalescent lesions cover large portions of body
  with extensive destruction of normal tissue.
• Lymphadenopathy, splenomegaly, or other signs of
  inflammatory response.
• May progress to toxic or septicemic shock, DIC,
  superimposed systemic fungal symptoms, parasitic
  infection symptoms, bacterial infections, or
  septicemia.

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Photo credit J. Michael Lane, MD MPH CDC
Teaching slide set Adverse reactions following
smallpox vaccination
95
Progressive Vaccinia vs. Severe Take

• Distinguishing features of severe take
• Resolves in 1-2 weeks w/o therapy
• Has signs and symptoms of inflammatory response
• Pain is present
• Lesion does not rapidly extend
• Absence of metastatic lesions
• Occurs in immunocompetent host

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SCID
Lymphoma and PV
Progressive vaccinia
Photo credit V. Fulginiti, MD and Logical
Images http//www.bt.cdc.gov/training/smallpoxvacc
ine/reactions/default.htm
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Central Nervous System Disease post-vaccination

• Usually affects primary vaccinees lt12 months of
  age and adolescents and adults receiving a
  primary vaccination
• Presents with any of a variety of CNS signs
  (e.g., ataxia, confusion, paralysis, seizures, or
  coma)
• 15-25 die, 25 develop neurological sequelae

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Post-vaccinial encephalitis and
(PVE)/Post-vaccinial encephalomyelitis (PVEM)

• PVE - lt2 years of age
• 6-10 days post-vaccination
• Cerebral vascular changes
• PVEM - gt2 years of age
• 11-15 days post-vaccination
• Demyelinating changes

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PVEM and PVE Diagnosis and evaluation

• Diagnosis of exclusion
• Other infectious or toxic causes of encephalitis
  should be ruled out
• Pathophysiology not well understood but thought
  to be immune response
• CSF findings normal or nonspecific
• Use of modern imaging studies has not been
  evaluated

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PVE and PVEM Treatment

• Treatment is supportive
• VIG not effective
• Anticonvulsive therapy and intensive care may be
  required

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Fetal Vaccinia

• Disseminated viremia with characteristic lesions
• Rare complication (lt50 cases reported)
• Cases reported in association with all
  trimesters, but greatest risk appears to be 3rd
  trimester
• Outcomes premature birth, fetal loss, high
  mortality
• No known pattern of congenital malformations

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FETAL VACCINIA
Photo credit J. Michael Lane, MD MPH CDC
Teaching slide set Adverse reactions following
smallpox vaccination
103
Fetal Vaccinia

• Death usually occurs before birth or in perinatal
  period
• Route of transmission unknown
• VIG may be considered if infant born alive with
  lesions
• Antivirals not recommended
• No known reliable intrauterine diagnostic test

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Fetal vaccinia
Photo credit J. Michael Lane, MD MPH CDC
Teaching slide set Adverse reactions following
smallpox vaccination
105
Post-vaccination Responsibilities

• Careful care of your site
• Stay hydrated drink fluids
• Adverse reactions
• Call to report
• Follow-up with your primary care physician
• Emergency care if needed

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Reporting Adverse Events Following Smallpox
Vaccine

• Report clinically significant or unexpected Aes
• When clinically significant/unexpected AEs
  within 48 hours and other AEs within 7 days
• Who can report SHDs, providers, vaccinees,
  manufacturers
• How to report
• http//secure.vaers.org/VaersDataEntry.cfm
• Fax [phone]
• Telephone [phone] for form

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Next steps

• Voluntary program determine your risk
• Vaccination clinics next week
• Post-vaccination training
• Phase 2 vaccinations
• Prepared for mass vaccination (if event)

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Calendar Vaccination clinics

• 3/3 Vaccination clinic 1
• 3/10 Check takes (day 7 clinic 1)
• 3/6 Vaccination clinic 2 (makeup/overflow)
• 3/13 Check takes (day 7 clinic 2)

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Calendar Post-vax training

• Phase 1 Post-vaccination training (6 hours) on
  3/20
• Identify and prioritize roles of public health
  response team member
• In event of smallpox exposure event (4 hours)
• As member of vaccination team (two 1-hour
  workshops)

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Calendar Phase 2 schedule

• To be determined

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For More Information

• CDC Smallpox website
• www.cdc.gov/smallpox
• National Immunization Program website
  www.cdc.gov/nip

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Acknowledgements sources for slides and
materials

• Anthony J. Carbone, MD, MS, MPH
• The Harvard Center For Public Health Preparedness
• Harvard School of Public Health
• Centers for Disease Control and Prevention
• Certain images supplied by
• Dr. J. Michael Lane
• Dr. Vincent Fulginiti
• Dr. Henry Kempe
• Dr. John Leedom
• NEJM
• National Institutes of Health
• Logical Images, Inc.

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Acknowledgements

• Anthony J. Tomassoni, MD, MS, FACEP, DACMT
• Medical Director
• OPHEP
• Jo E. Linder, MDMedical Officer, Southern
  RegionHHSD/Portland Public Health

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Thank You for Volunteering!