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, FAC...
Phase 1 Pre-vaccination
Objectives
 Explain need for public health andExplain need for public health and
hospital smallpo...
Phase 1 Pre-vaccination
Objectives
 Describe smallpox vaccinationDescribe smallpox vaccination
administration proceduread...
Phase 1 Pre-vaccination
Objectives
 Recognize smallpox vaccinationRecognize smallpox vaccination
common and serious adver...
CDC VIDEO
SMALLPOXSMALLPOX 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 caus...
Why fear smallpox as BW?
 Case fatality rate of 30% +Case fatality rate of 30% +
 No specific therapyNo specific therapy...
Why fear smallpox?
 Used in the past as a BWUsed in the past as a BW
 Smallpox invokes terrorSmallpox invokes terror
 W...
Diagnosis and Management of Smallpox NEJM 346;17:1300-1308 April 25, 2002
Joel G. Breman, MD, DTPH, and D.A. Henderson, MD...
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 theA case of smallpox anywhere in the
worldworld
““The discovery o...
Smallpox TREATMENT
 Vaccinia vaccination by the 4Vaccinia vaccination by the 4thth
dayday
of exposure.of exposure.
 No s...
Vistide®
(cidofovir)
 Cidofovir unknownCidofovir unknown
benefit against smallpoxbenefit against smallpox
 Toxic side-ef...
ME smallpox vaccination plan
General Concepts
 Vaccination targeted to Public HealthVaccination targeted to Public Health
Smallpox Response Teams and ...
Calendar
 11/21/02 Request to states for pre-event and11/21/02 Request to states for pre-event and
post-event smallpox pl...
Arrival in ME: Jan. 28
Calendar: screening
 2/18/03 Smallpox volunteers receive email2/18/03 Smallpox volunteers receive email
pre-vaccination s...
VACCINE CONTRAINDICATIONS
 Eczema or atopic dermatitisEczema or atopic dermatitis
 Active skin conditionsActive skin con...
 Serious allergic reaction to a prior dose ofSerious allergic reaction to a prior dose of
DryvaxDryvax®® vaccine or vacci...
VACCINE CONTRAINDICATIONS
 Eczema/Atopic Dermatitis:Eczema/Atopic Dermatitis:
 Rash involves flexuresRash involves flexu...
VACCINE CONTRAINDICATIONS
 Allergic to the vaccineAllergic to the vaccine
 Younger than 12 months of ageYounger than 12 ...
Smallpox Vaccine
NYC Board of HealthNYC Board of Health
Live Vaccinia VirusLive Vaccinia Virus
DryvaxDryvax®®
Wyeth Labora...
VACCINE INDICATIONS
People who have beenPeople who have been
directly exposeddirectly exposed to theto the
smallpox virus ...
Vaccinia
 Vaccinia virus is a poxvirus.Vaccinia virus is a poxvirus.
 Vaccinia is related to variola but milder.Vaccinia...
Vaccinia: “Live Virus” Vaccine
 Contains a "living" virus that is able to giveContains a "living" virus that is able to g...
Smallpox Vaccination: Immunity
 High level immunity for 3 to 5 years.High level immunity for 3 to 5 years.
 Immunity wan...
Smallpox Vaccination: Immunity
 Vaccination within 3 days of exposure willVaccination within 3 days of exposure will
prev...
Calendar: training
 2/26/03 Phase 1 Pre-vaccination training (22/26/03 Phase 1 Pre-vaccination training (2
hours)hours)
...
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 Bifur...
Step-by-Step Method for Vaccination
1. Skin Preparation: None.1. Skin Preparation: None.
**Under no circumstancesUnder no ...
Step-by-Step Method for Vaccination
2. Dip Needle2. Dip Needle
The needle is dipped into the vaccine vial and withdrawn.Th...
Step-by-Step Method for Vaccination
3. Make 15 perpendicular insertions3. Make 15 perpendicular insertions
within a 5mm di...
Step-by-Step Method for Vaccination
4. Absorb excess vaccine.4. Absorb excess vaccine.
Cover site with sterile dressing
 Virus can be recovered at site from time ofVirus can be recovered at site from time of
papule until scab separatespapule...
Vaccination Site Care
 Cover the vaccination site loosely with a gauzeCover the vaccination site loosely with a gauze
ban...
Vaccination Site Care
Keep the vaccination site dry.Keep the vaccination site dry.
Put the contaminated bandages in a se...
Vaccination Site Care
 DoDo notnot use a bandage that blocks all air from theuse a bandage that blocks all air from the
v...
Vaccinia: Vaccination Site
““Major Reaction” (vs. “EquivocalMajor Reaction” (vs. “Equivocal
Reaction”)Reaction”)
 First VaccinationFirst Vaccination
 Vesicular or pustular lesionVesicular or pustular lesion
 Area of definite palpabl...
 RevaccinationRevaccination
 Less pronounced and more rapidLess pronounced and more rapid
progressionprogression
 Pustu...
 Swelling and tenderness of axillarySwelling and tenderness of axillary
lymph nodes, usually during 2lymph nodes, usually...
Normal Reaction
Day 7
Normal Reaction
Day 12
Major Reaction
First time vaccinee, Day 10
Major Reaction
First time vaccinee, Day 15
Major Reaction
Revaccinee, Day 4
Major Reaction
Revaccinee, Day 8
Major Reaction
Revaccinee, Day 10
Major Reaction
Revaccinee, Day 15
 FatigueFatigue
 HeadacheHeadache
 MyalgiaMyalgia
 LymphadenopathyLymphadenopathy
 LymphangitisLymphangitis
 Pruriti...
Rates of Expected Reactions
 21% complications required physician consult21% complications required physician consult
 M...
Administrative Leave
 Do not need to place HCWs on leave,Do not need to place HCWs on leave,
unless:unless:
 Physically ...
MMWR: Feb 21, 2001/52(02):136
n = 4,213 health-care
workers in 27 different
cities and counties
7 (~ 0.17 %) nonserious
ad...
US Military Data as of 2/12/03
 DoD healthcare workers vaccinated againstDoD healthcare workers vaccinated against
smallp...
US Military Data as of 2/12/03
Sick Leave (SL) OverallSick Leave (SL) Overall 3% of vaccinated People3% of vaccinated Peop...
Smallpox Vaccine Adverse Reactions
 Nonspecific dermatological conditionsNonspecific dermatological conditions
 Inadvert...
Vaccinia: Adverse Reactions
The most frequent adverseThe most frequent adverse
complication of vaccination iscomplication ...
Inadvertent Inoculation
 Transfer of vaccinia virus from vaccination siteTransfer of vaccinia virus from vaccination site...
Adverse Vaccination Reactions
Accidental ImplantationAccidental Implantation
Inadvertent Inoculation
 Hand washing after contact with vaccinationHand washing after contact with vaccination
site or c...
Nonspecific rash following smallpox vaccination
Vaccination
site
Photo credit: J. Michael Lane, MD MPH
CDC Teaching slide ...
Nonspecific Rashes
 Flat, erythematous, macules or patches, andFlat, erythematous, macules or patches, and
generalized ur...
Nonspecific rash following smallpox vaccination
Photo credit: Vaccination reactions in vaccinia-naive volunteers in a
clin...
Photo credit: V. Fulginiti, MD and Logical Images
http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm
ERY...
Adverse Vaccination Reactions
Auto-inoculationAuto-inoculation
Ocular Vaccinia
 May present as blepharitis, conjunctivitis,May present as blepharitis, conjunctivitis,
keratitis, iritis...
Secondary Corneal Infection
Adverse Vaccination Reactions
Vaccinia KeratitisVaccinia Keratitis
Adverse Vaccination Reactions
Bacterial InfectionsBacterial Infections
Adverse Vaccination Reactions
Generalized VacciniaGeneralized Vaccinia
Vaccination site
Regional form
Sometimes resembles
Smallpox
Photo credit: J. Michael Lane, MD MPH
CDC Teaching slide set
A...
Adverse Vaccination Reactions
Generalized vacciniaGeneralized vaccinia
Adverse Vaccination Reactions
Eczema VaccinatumEczema Vaccinatum
Multiple umbilicated
EV papular lesions
Healed EV
EV predilection for sites of
atopic dermatitis (eczema)
Photo credit: V....
Adverse Vaccination Reactions
Eczema vaccinatumEczema vaccinatum
Adverse Vaccination Reactions
Progressive VacciniaProgressive Vaccinia
““Vaccinia Necrosum/Gangrenosa”Vaccinia Necrosum/Ga...
Adverse Vaccination Reactions
Progressive VacciniaProgressive Vaccinia
Photo credit: J. Michael Lane, MD MPH
CDC Teaching slide set Adverse reactions
following smallpox vaccination
Atypical PV ...
Progressive vaccinia
Photo credit: V. Fulginiti, MD and Logical Images
http://www.bt.cdc.gov/training/smallpoxvaccine/reac...
FETAL VACCINIA
Photo credit: J. Michael Lane, MD MPH
CDC Teaching slide set Adverse reactions
following smallpox vaccinati...
Fetal vaccinia
Photo credit: J. Michael Lane, MD MPH
CDC Teaching slide set Adverse reactions
following smallpox vaccinati...
Post-vaccination Responsibilities
 Careful care of your siteCareful care of your site
 Stay hydrated – drink fluidsStay ...
Reporting Adverse Events Following
Smallpox Vaccine
 Report – clinically significant or unexpected AesReport – clinically...
Next steps
 Voluntary program: determine your riskVoluntary program: determine your risk
 Vaccination clinics next weekV...
Calendar: Vaccination clinics
 3/3 Vaccination clinic 13/3 Vaccination clinic 1
 3/10 Check “takes” (day 7 clinic 1)3/10...
Calendar: Post-vax training
 Phase 1 Post-vaccination training (6Phase 1 Post-vaccination training (6
hours) on 3/20hours...
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 Immuni...
Acknowledgements:
sources for slides and materials
 Anthony J. Carbone, MD, MS, MPHAnthony J. Carbone, MD, MS, MPH
The Ha...
Acknowledgements:
Anthony J. Tomassoni, MD, MS, FACEP, DACMTAnthony J. Tomassoni, MD, MS, FACEP, DACMT
Medical DirectorMed...
Thank You for Volunteering!
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  • SMALLPOX (VARIOLA):
    Smallpox is a severe, febrile, contagious, sometimes fatal disease caused by the virus “variola” that is characterized by a vesicular and pustular eruption.
    There is no specific treatment for smallpox, and the only preventions are surveillance, isolation, and vaccination.
    Sources:
    CDC Smallpox Website: http://www.bt.cdc.gov/agent/smallpox/overview/disease-facts.asp.
    Fenner F, Henderson DA, Arita I, Jezek Z, Ladnyi ID. Smallpox and its Eradication. Geneva, Switzerland: World Health Organization; 1988.
    Wang F. Harrison’s, Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
    [Note: The photograph of this infant with smallpox, as well as the majority of smallpox slides in this presentation, is courtesy of the Centers for Disease Control and Prevention’s (CDC) Public Health Image Library (PHIL) available online at: http://phil.cdc.gov/phil/default.asp.]
  • <number>
    WHY SHOULD WE FEAR SMALLPOX AS A BIOLOGICAL WEAPON?
    First of all, it’s lethal; case fatality rate of 30-50% historically, but could be much higher in weaponized strains; in addition to its high mortality rate, smallpox has a morbidity rate of 60-90% leaving victims scarred, and many blind.
    No specific therapy exists for smallpox;
    Infectious dose is small, could be as low as one to two viral particles in an aerosol;
    Transmission rate of smallpox is high at 1:10-20.
    Source:
    Alibek K, Handelman S. Biohazard: The Chilling Story of the Largest Weapons Program in the World—Told From Inside by the Man Who Ran It. New York: Dell Publishing, 1999.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
  • <number>
    WHY SHOULD WE FEAR SMALLPOX AS A BIOLOGICAL WEAPON?
    Smallpox has been used in the past as a BW and has been developed for use as a BT agent;
    Smallpox invokes terror. It’s highly feared disease due to death, disfiguring, blindness and its history;
    Smallpox has been weaponized and is stable in aerosol form; and
    US stopped vaccinating 25+ years ago. The WHO Assembly recommended that all countries cease vaccination in 1980. And the vaccinia vaccine is thought to protect for 5, maybe 10 years the most.
    Source:
    Alibek K, Handelman S. Biohazard: The Chilling Story of the Largest Weapons Program in the World—Told From Inside by the Man Who Ran It. New York: Dell Publishing, 1999.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
  • <number>
    BIOPREPARAT:
    USSR began producing smallpox in large quantities in 1980. Majority of smallpox work took place at the Center of Virology in Sergiyev Posad, formerly known as Zagorsk.
    Capable of producing several tons of variola annually.
    Militarized smallpox for use in bombs, ICBMs, and cruise missiles.
    Russia has been researching more virulent and contagious recombinant strains of variola.
    Sources:
    Alibek K, Handelman S. Biohazard: The Chilling Story of the Largest Weapons Program in the World—Told From Inside by the Man Who Ran It. New York: Dell Publishing, 1999.
    Alibek K, “Terrorist and Intelligence Operations: Potential Impact on the U.S. Economy,” Statement before the Joint Economics Committee, United Stats Congress, May 20, 1998.
  • <number>
    IRAQI BW PROGRAM: CIA Report October 2002
    “All key aspects—R&D, production, and weaponization—of Iraq's offensive BW program are active and most elements are larger and more advanced than they were before the Gulf war.
    Iraq has some lethal and incapacitating BW agents and is capable of quickly producing and weaponizing a variety of such agents, including anthrax, for delivery by bombs, missiles, aerial sprayers, and covert operatives, including potentially against the US Homeland.
    Baghdad has established a large-scale, redundant, and concealed BW agent production capability, which includes mobile facilities; these facilities can evade detection, are highly survivable, and can exceed the production rates Iraq had prior to the Gulf war.
    Iraq has the capability to convert quickly legitimate vaccine and biopesticide plants to biological warfare (BW) production and already may have done so.  This capability is particularly troublesome because Iraq has a record of concealing its BW activities and lying about the existence of its offensive BW program.
    After four years of claiming that they had conducted only "small-scale, defensive" research, Iraqi officials finally admitted to inspectors in 1995 to production and weaponization of biological agents.  The Iraqis admitted this only after being faced with evidence of their procurement of a large volume of growth media and the defection of Husayn Kamil, former director of Iraq's military industries.”
    Source: CIA Report, “Iraq's Weapons of Mass Destruction Programs,” October 2002. Available on-line at: http:// www.cia.gov/cia/publications/ iraq_wmd/Iraq_Oct_2002.htm
  • LAST CASE OF VARIOLA MAJOR: Bhola Island, 1975
    The last case of naturally occurring variola major occurred October 16, 1977 in a 3-year old girl named Rahima Banu on Bhola Island off the coast of Bangladesh. She survived her bout of smallpox.
    Source: CDC Smallpox Website at http://www.bt.cdc.gov/agent/smallpox/index.asp.
  • NOTIFICATION:
    “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.”
    Source: Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999.
  • <number>
    TREATMENT Of SMALLPOX:
    According to the CDC, there are two FDA-approved medications that may help persons who have certain serious reactions to the smallpox vaccine:
    vaccinia immune globulin (VIG) and
    cidofovir.
    VIG has been extensively used in the past and felt (but not shown in controlled studies) to be effective.
    Cidofovir, an anti-viral approved by the FDA to treat CMV in HIV patients, may be effective based on studies in animals. Treatment with these medications may require the vaccine recipient to be in the hospital. They are investigational and may cause a number of serious side effects themselves.
    Source: Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
  • <number>
    TREATMENT Of SMALLOX: Vistide® (cidofovir)
    Cidofovir is an antiviral drug approved by the FDA in June 1996 to treat cytomegalovirus (CMV) retinitis, a sight-threatening infection commonly found in people with late stage HIV disease, may be effective in treating smallpox.
    Cidofovir is a nucleoside analog DNA polymerase inhibitor, might prove useful in preventing smallpox infection if administered within 1 to 2 days after exposure.
    Source: Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 2132.
    MORE INFORMATION ON CIDOFOVIR:
    Researchers at the U.S. Army Medical Research Institute of Infectious Diseases in March 1998 found that the drug, produced by Gilead Sciences, could prevent a pox disease in primates that is similar to smallpox in humans. Both diseases cause respiratory problems, fever and rash. Researchers from the Departments of Defense and Veterans Affairs announced their findings in March at an international conference on antiviral research in Prague in the Czech Republic. The drug, called hexadecloxypropyl-cidofovir (HDP-CDV), is a derivative of the drug cidofovir, which is currently approved by the Food and Drug Administration to treat an eye infection that is a complication of AIDS. The newly derived drug is absorbed intact into the body and once in the tissue the cidofovir portion is activated and prevents the disease from replicating itself. Researchers have found the drug to be effective against smallpox and the closely related cowpox disease. Though the drug has only been tested in mice, researchers at the U.S. Army Medical Research Institute of Infectious Diseases are conducting further studies this year. Researchers involved in the VA study said HDP-CDV, a potent derivative of cidofovir, would be more useful than its parent drug in the event of a massive smallpox outbreak because cidofovir can only be taken intravenously. "If you've got thousands of people exposed to smallpox, oral treatment would be far more effective," said Dr. Karl Y. Hostetler, director of the Endocrine and Metabolism Clinic at the VA San Diego Healthcare System and professor of medicine at the University of California-San Diego. The promising smallpox drug could be given in pill or capsule form over 5-14 days for prevention or treatment following exposure if continuing studies support its safety and effectiveness, Dr. Hostetler said.
  • <number>
    These pictures show a smaller unit called the Vaxipacs. The Vaxipacs are designed to be complimentary to the Vaxicool or another approved refrigeration unit. The basic concept is to take a small number of vials of vaccine from a larger storage area and redistribute them through hospital or regional area for a short period of time. The Vaxipac utilizes chemical and vacuum insulated technology as opposed to the state-of-the-art electronics found in the Vaxicool.
  • <number>
  • CURRENT SMALLPOX VACCINE: Dryvax Live Vaccinia Vaccine
    The current smallpox vaccine stored by the CDC is the same vaccine used in the United States prior to 1980; Manufactured by Wyeth Laboratories in Marietta, Pennsylvania under the trade name, Dryvax®. Dryvax uses the NYC Board of Health Strain of live vaccinia virus (it does not contain the smallpox virus, variola) produced from scarified calves. Lymph is collected, purified, then freeze-dried. The vial of Dryvax needs to be reconstituted with a dilutent prior to vaccination. Traditionally, the vials contained sufficient vaccine for at least 50 doses when a bifurcated needle is used.1,3
    A national study led by researchers at Saint Louis University School of Medicine found that the country's limited stockpile of the smallpox vaccine could be diluted up to 10 times and retain its potency. The trial studied various strengths of Dryvax in 680 young adults showed that it remains effective at dilutions of 1:5 and 1:10. Those results, published in the April 2002 edition of JAMA, showed no significant differences in take rates between the full-strength vaccine and the two dilutions. Diluting the existing stockpile by 1:5 would increase it to about 77 million doses. The results of the study suggest the vaccine could be stretched to protect a greater number of Americans from the highly contagious virus, which public health officials fear terrorists might use in a biological attack.2
    HHS currently has a stockpile of about 15.4 million doses of Dryvax. The department has contracted with Acambis Inc. and its partner, Baxter International, to produce another 209 million doses of vaccinia vaccine from cell culture.
    Sources:
    1CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/live-virus.asp
    2Frey SH, et al. Clinical Responses to Undiluted and Diluted Smallpox Vaccine. NEJM. April 25, 2002; 346: 1265-1274. Available online at: http://content.nejm.org/cgi/content/full/346/17/1265.
    3Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2132.
  • VACCINE INDICATIONS:
    According to the CDC, people who have been directly exposed to the smallpox virus should get the vaccine, regardless of their health status.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC Smallpox Website at: http://www.bt.cdc.gov/agent/smallpox/vaccination/contraindications-public.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    VACCINIA:
    The vaccinia virus is another poxvirus.
    Vaccinia is related to variola (smallpox) but milder.
    Antigenic similarity allows for cross-reactivity enabling vaccinia vaccination to protect against smallpox
    The vaccinia virus may cause rash, fever, and head and body aches. In certain groups of people, complications from the vaccinia virus can be severe.
    Vaccinia is spread by touching a vaccination site before it has healed or by touching bandages or clothing that have been contaminated with live virus from the smallpox vaccination site.
    Sources:
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/live-virus.asp.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    VACCINIA: LIVE VIRUS VACCINE
    The current vaccine against smallpox utilizes vaccinia which is a live virus vaccine.
    A "live virus" vaccine is a vaccine that contains a "living" virus that is able to give and produce immunity, usually without causing illness.
    Because the virus in the smallpox vaccine is live, it can be transmitted to other parts of the body or to other people and so the site must be cared for carefully.
    For most people with healthy immune systems, live virus vaccines are effective and safe.
    Sometimes a vaccinee experiences mild symptoms associated with the virus in the vaccine.
    Other live virus vaccines used include measles, mumps, rubella, and chickenpox.
    Source: CDC smallpox website, http://www.bt.cdc.gov/agent/smallpox/vaccination/live-virus.asp.
  • <number>
    PRE-EXPOSURE VACCINATION: Immunity
    Antigenically, poxviruses induce both specific and cross-reacting antibodies - hence ability to vaccinate against one disease with another virus.
    Smallpox vaccination provides high level immunity for 3 to 5 years and decreasing immunity thereafter. If a person is vaccinated again later, immunity lasts even longer. Immunity wanes after 10 to 20 years.1 Revaccination is recommended every 10 years for continued protection.
    Routine smallpox vaccination was discontinued in America in 1971 and has not been required for international travel since 1981.2
    Sources:
    1CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    2Fred Wang, Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    PRE-EXPOSURE VACCINATION: Immunity
    The immune status of those vaccinated 27 years ago in not clear. The duration of immunity, based on the experience of naturally exposed susceptible person, has never been satisfactorily measured. Neutralizing antibodies are reported to reflect levels of protection, although this has not been validated in the field. These antibodies have been shown to decline substantially during a 5- to 10-year period.1
    Thus, those who received the recommended single-dose vaccination as a child do not have lifelong immunity.1
    However, among a group who were vaccinated at birth, and at ages 8 and 18 years as part of a study, were found to have stable levels of neutralizing antibodies during a 30-year period.2
    Sources:
    1Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    2El-Ad R, Rogh Y, Winder A. The persistence of neutralizing antibodies after revaccination against smallpox. Journal of Infectious Disease. 1990; 161L 446-448.
  • SMALLPOX VACCINATION METHOD: Multiple Puncture Vaccination Using Bifurcated Needle
    In the past, vaccination was performed by the scratch or multiple insertion method. During the global eradication effort, the bifurcated needle came to be used universally along with a technique called multiple puncture vaccination. This is now the recommended method in the United States.
    Each bifurcated needle is sterile and individually wrapped. The bifurcated needle is for single usage only and should be discarded in an appropriate biohazard container immediately after vaccinating each patient.
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • STEP-BY-STEP METHOD FOR VACCINATION:
    1. Skin Preparation: None
    No skin preparation is required. Under no circumstances should alcohol be applied to the skin prior to vaccination as it has been shown to inactivate the vaccine virus. 
    Preferred Site for Vaccination: Deltoid area on the upper arm. In the past, other sites have been chosen, such as the back or inner aspects of the extremities, or even the buttock. These other sites were selected based on “cosmetic” concerns. It is strongly recommended that the deltoid site be used. Some experts cite the fact that there is differential skin sensitivity to vaccination and that most of the efficacy studies analyzed vaccinees who received deltoid vaccinations.
    Source: CDC’s “Smallpox Vaccination and Adverse Effects Training Module,” available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
  • 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. 
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • STEP-BY-STEP METHOD FOR VACCINATION:
    3. Make 15 Perpendicular Insertions within a 5mm Diameter Area
    The needle is held perpendicular to the site of insertion. The wrist of the vaccinator should be maintained in a firm position by resting on the arm of the vaccinee or other firm support.
    Fifteen perpendicular insertions are made in rapid order in an area approximately 5 mm in diameter.
    Strokes should be vigorous enough to evoke a trace of blood at the site after 15-30 seconds.
    The bifurcated needle is for single usage only and should be discarded in an appropriate biohazard container immediately after vaccinating each patient.
    Caution: Needles should never be dipped into the vaccine vial more than once, in order to avoid contamination of the vial. 
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • STEP-BY-STEP METHOD FOR VACCINATION:
    4. Absorb Excess Vaccine
    After vaccination, excess vaccine should be absorbed with sterile gauze. Discard the gauze in a safe manner (usually in a hazardous waste receptacle) in order not to contaminate the site or infect others who may come in contact with it. 
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • Cover the vaccination site to prevent dissemination of the virus. The site should be covered by a gauze pad then tape applied over the gauze. For hospital personnel, the gauze should in turn be covered by a semi-permeable occlusive dressings. Semi-permeable dressing alone should not be used because it cause skin maceration and may increase the risk of secondary bacterial cellulitis.
  • Vaccinia virus may be cultured from the site of primary vaccination beginning at the time of development of a papule (2 to 5 days after vaccination) until the scab separates from the skin lesion (14 to 21 days after vaccination). During this time, care must be taken to prevent spread of the virus to another area of the body or to another person. The vaccination site may be left uncovered or can be covered with a porous bandage, such as gauze, until the scab has separated and the underlying skin has healed.
    No salves or ointments should be used on the vaccination site. Contaminated bandages should be placed in sealed plastic bags before disposal in the trash. Clothing or other cloth materials that have had contact with the site can be decontaminated with routine laundering in hot water with bleach.2 The vaccination site should be kept dry, although normal bathing can continue if covered by waterproof bandage.
  • <number>
    STEP-BY-STEP METHOD FOR VACCINATION: Things you should do for care of the vaccination:
    Cover the vaccination site loosely with a gauze bandage, using medical tape to keep it in place. Keep it covered until the scab has separated on its own. This bandage will provide a barrier to protect against spread of the vaccinia virus. (Health care workers involved in direct patient care should cover the gauze with a semi-permeable dressing as an additional barrier.)
    You can wear a shirt that covers the vaccination site as an extra precaution to prevent spread of the vaccinia virus. This is particularly important in situations of close personal contact.
    Change the bandage every 1–2 days. This will keep skin at the vaccination site from softening and wearing away.
    Wash hands with soap and warm water after direct contact with the bandage or after direct contact with the vaccination site. This is vital in order to remove any virus from your hands and prevent contact spread.Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • <number>
    STEP-BY-STEP METHOD FOR VACCINATION: Things you should do for care of the vaccination (con’t):
    Keep the vaccination site dry. Cover the vaccination site with a water-resistant pad, such as a waterproof band-aid when you bathe. Remember to change back to the loose gauze bandage after bathing.
    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. Use hot water with detergent and/or bleach.
    When the scab comes off, throw it away in a sealed plastic bag (remember to wash your hands afterwards).
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • <number>
    STEP-BY-STEP METHOD FOR VACCINATION: Care of the vaccination site (some DON’Ts):
    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.
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
  • VACCINIA:
    Formation of a pustule and scab at the site of inoculation is indicative of immunity.
    If the vaccination is successful, a red and itchy bump develops at the vaccine site in three or four days. In the first week, the bump becomes a large blister, fills with pus, and begins to drain. During the second week, the blister begins to dry up and a scab forms. The scab falls off in the third week, leaving a small scar. People who are being vaccinated for the first time have a stronger reaction than those who are being revaccinated. The following pictures show the progression of the site where the vaccine is given.
    Sources:
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/live-virus.asp.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • For those patients receiving their first smallpox vaccination, a vesicular or pustular lesion should develop with an area of definite palpable induration surrounding a central crust or ulcer.
    For those patients who are being revaccinated, there will be a less pronounced lesion with more rapid progression. A revaccinated patient is considered to have had a major reaction if they produce a pustular lesion or have an induration surrounding a central crust or ulcer.
  • For those patients receiving their first smallpox vaccination, a vesicular or pustular lesion should develop with an area of definite palpable induration surrounding a central crust or ulcer.
    For those patients who are being revaccinated, there will be a less pronounced lesion with more rapid progression. A revaccinated patient is considered to have had a major reaction if they produce a pustular lesion or have an induration surrounding a central crust or ulcer.
  • Individuals receiving their first dose of vaccine normally experience tenderness, redness, and swelling at the vaccination site. Primary vaccination may also be associated with fever for a few days and enlarged, tender lymph nodes in the axilla of the vaccinated arm.
  • Formation by days 6-8 post-vaccination of a papule, vesicle, ulcer, or crusted lesion, surrounded by an area of induration signifies a response to vaccination; this event is referred to as a major reaction or a “take,” and usually results in a scar. During the smallpox eradication era, individuals with a scar had much lower attack rates when exposed to smallpox cases than did unvaccinated individuals. Therefore, a take has been a surrogate correlate of immunity to smallpox. Although the level of antibody that protects against smallpox infection is unknown, >95% of first-time vaccinees (i.e., persons receiving their first dose of smallpox vaccine) have increased neutralizing or hemagglutination inhibition antibody titers.
    ==================================
    Annotation: Normal reaction (taken day 7 post-vaccination)
    Source: “Vaccination reactions in vaccinia-naïve volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louise University, University of Maryland and University of Rochester and the Respiratory Pathogens Unit at Baylor College of Medicine in 2001.”
  • Here is the normal smallpox reaction around day 12. Note how the pustule is drying from the center outward.
    ==================================
    Annotation: Normal reaction (taken day 12) heaped up border with pustule drying from center outward.
    Source: “Vaccination reactions in vaccinia-naïve volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louise University, University of Maryland and University of Rochester and the Respiratory Pathogens Unit at Baylor College of Medicine in 2001.”
  • The World Health Organization (WHO) has recommended that response to vaccination be evaluated on post-vaccination day 6, 7, or 8. These are the days of peak viral replication, and the period during which take should be assessed in both first-time vaccinees and re-vaccinees. If the response to vaccination is evaluated too early, <6 days post-vaccination, some equivocal responses will look reactive due to dermal hypersensitivity to vaccinial proteins. These were sometimes called “immediate reactions” but are not successful takes.
    =================================
    Annotation: Example of a major reaction in a first time vaccinee at 10 days post-vaccination
    Source: Vaccination reactions in vaccinia-naïve and previously vaccinated volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louis University in 2002.
  • Here is another example of a major reaction.
    =====================================
    Annotation: Example of a major reaction in a first time vaccinee at 15 days post-vaccination
    Source: Vaccination reactions in vaccinia-naïve and previously vaccinated volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louis University in 2002.
  • If the response to vaccination is evaluated too late, >8 days post-vaccination, the vaccination take may be missed in those individuals with prior immunity to vaccinia who may experience a more rapid progression of the vaccination site.
    Responses in revaccinees that resolve in fewer than 6 days were sometimes called “accelerated reactions,” and are not successful takes.
    ===========================================
    Annotation: Example of a major reaction in a re-vaccinee at 4 days post-vaccination. This is in contrast to an equivocal reaction (non-reaction) in a first-time vaccinee.
    Source: Vaccination reactions in vaccinia-naïve and previously vaccinated volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louis University in 2002.
  • Here is another example of a major reaction in a re-vaccinee. Note how it differs from a major reaction in the first time vaccinee.
    ==========================
    Annotation: Example of a major reaction in a re-vaccinee at 8 days post-vaccination. This is in contrast to an equivocal reaction (non-reaction) in a first-time vaccinee.
    Source: Vaccination reactions in vaccinia-naïve and previously vaccinated volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louis University in 2002.
  • This is another example of a major reaction in a re-vaccinee.
    =======================
    Annotation: Example of a major reaction in a re-vaccinee at 10 days post-vaccination. This is in contrast to an equivocal reaction (non-reaction) in a first-time vaccinee.
    Source: Vaccination reactions in vaccinia-naïve and previously vaccinated volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louis University in 2002.
  • Annotation: Example of a major reaction in a re-vaccinee at 15 days post-vaccination. This is in contrast to an equivocal reaction (non-reaction) in a first-time vaccinee.
    Source: Vaccination reactions in vaccinia-naïve and previously vaccinated volunteers in a clinical study of diluted Dryvax smallpox vaccine enrolled at the NIAID-supported Vaccine Treatment and Evaluation Units at Saint Louis University in 2002.
  • A range of expected reactions occurs following vaccination. These normal reactions do not require specific treatment, and may include fatigue, headache, myalgia, regional lymphadenopathy, lymphangitis, pruritis and edema at the vaccination site, as well as satellite lesions (1, [i]).
     
  • Historically, approximately 21% of complications associated with first-time vaccination were reactions that caused the vaccinee to consult a physician (1). In a recent vaccination trial of 680 adult, first-time vaccinees, Frey et al reported the most common symptoms during the first 2 weeks following vaccination were fatigue (50%), headaches (40%), muscle aches and chills (20%), nausea (20%), and fever described as a temperature greater than or equal 37.7ºC or 100°F (10%). Most local symptoms were reported during the second week following vaccination and included pain at the vaccination site (86%), and regional lymphadenopathy (54%). More than a third of vaccinees were sufficiently ill to miss school, work, recreational activities, or have trouble sleeping. These signs and symptoms have been reported to be self-limited, requiring only symptomatic care.
     
    A fever following vaccination is common and approximately 70% of children experience >1 days of temperatures >100 F for 4--14 days after primary vaccination, and 15%--20% of children experience temperatures >102 F. After revaccination, 35% of children experience temperatures >100 F, and 5% experience temperatures of >102 F. Fever is less common among adults after vaccination or revaccination.
    ==========================
    References:[i] Dryvax® [package insert]. Marietta, Pennsylvania: Wyeth Laboratories; 1994.
    [ii] Frey SE, Couch RB, Tacket CO, Treanor JJ, Wolff M, Newman FK, Atmar RL, Edelman R, Nolan CM,Belsche RB,. Clinical responses to undiluted and diluted smallpox vaccine. N Engl J Med 2002;347(17):1265-74.
    [iii] McIntosh K, Cherry JD, Benenson AS, et al. Standard percutaneous revaccination of children who received primary percutaneous vaccination. J Infect Dis 1977;135:155-66.
    [iv] CDC smallpox diary card database 2001, unpublished.
    [v] CDC unpublished data.
  • With respect to administrative leave for health care workers, the ACIP does not believe that health care workers need to be placed on leave because they received a smallpox vaccination. Administrative leave is not required routinely for newly vaccinated healthcare workers unless they are physically unable to work due to systemic signs and symptoms of illness, extensive skin lesions which cannot be adequately covered, or if they do not adhere to the recommended infection control precautions. It is important to realize that the very close contact required for transmission of vaccinia to household contacts is unlikely to occur in the healthcare setting.
    However, it is also recommended that vaccination of Smallpox Health Care Team members be phased in, starting with a small number of hospitals. Within a single institution, it would be prudent to designate a small proportion, e.g. 20-30% of the candidate healthcare workers, for the first phase of vaccinations to allow institutions to gain experience in post-vaccination management. The ACIP recognizes that the incidence of adverse events following vaccination of previously vaccinated persons is substantially less than in primary vaccinees, and therefore recommends that when feasible, previously vaccinated health care workers be included in this stage 1 vaccination program. It is also advisable to stagger vaccination of healthcare workers within an individual patient care unit by three weeks in order to minimize the number of vaccinated individuals who would be on sick leave concurrently in association with systemic effects of the vaccine, which usually occur at days 8-10 after inoculation.
  • Through February 18, the smallpox vaccine was administered to 4,213 health-care workers in 27 different cities and counties, according to the Centers for Disease Control (CDC). The seven volunteers reporting reactions to the inoculation equals less than 1 percent, or about .17 percent, of the vaccinees.
    The most common signs and symptoms of the non-serious complaints as fever (two), rash (two), malaise (two), pruritus (two), hypertension (two) and pharyngitis (two).
    MMWR, 2/21/2003
  • SMALLPOX VACCINATION PROGRAM SUMMARY
    DoD Smallpox Vaccination Program
    as of February 12, 2003
  • SMALLPOX VACCINATION PROGRAM SUMMARY
    DoD Smallpox Vaccination Program
    as of February 12, 2003
    An unknown number of the vaccinees experienced temporary symptoms such as itching, swollen lymph nodes, fever and malaise, the report stated, while “several dozen vaccine recipients developed ‘flat’ rashes that are not dangerous and not contagious.” The report said that these people were treated for their symptoms and stayed on the job.
    The report stated that 3 percent of vaccinated people took sick leave, with the average length of a day and a half.
    Among the noteworthy cases described in the report, two US Army soldiers were diagnosed with encephalitis eight and nine days after receiving the vaccination. In both cases, according to the report, the vaccinia could not be established as the cause, but the timing was viewed as circumstantial evidence. Both soldiers eventually returned to their units.
    A US Air Force airman developed chest pain 11 days after receiving the vaccination. He was diagnosed with myocarditis, stayed two nights in the hospital and was scheduled to return to his unit. Again, the report stated that studies could not conclusively link the condition to the vaccinia, but the timing acts as circumstantial evidence.
    About 10 days after receiving a smallpox vaccination, another US Army solider developed a rash that included several pustules described in the report as “generalized vaccinia.” The solider continued to work.
    “Mild conditions” of generalized vaccinia were also reported in two members of the US Air Force and four members of the US Marine Corps. They also were treated as outpatients and remained on the job, the report stated.
    Another soldier developed redness in the eyes, and was treated as a case of possible ocular vaccinia. The report stated that laboratory tests did not find the vaccinia virus in his eye, and he remained on the job.
    William Winkenwerder Jr., MD, Assistant Secretary of Defense for Health Affairs stated in the report that “we continue to experience the types of reactions that we expected overall. Our expert medical advisors have indicated that the small number of skin-related reactions seen are quite mild and may not qualify as generalized vaccinia. Close monitoring has afforded these individuals prompt, effective care.”
  • VACCINIA COMPLICATIONS:
    The frequency of complications associated with use of the New York Board of Health strain (the strain used throughout the United States and Canada for vaccination) is the lowest for any established vaccinia virus strain, but the risks are not inconsequential.
    The most frequent adverse complication of vaccination is inadvertent inoculation at other sites. This usually occurs in the form of autoinoculation.
    Source:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2132.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • ADVERSE VACCINATION REACTIONS: Accidental Implantation
    The florid vaccination site contains high titers of vaccinia virus. Transfer of this virus from the primary site to other parts of the body, or to other individuals is a constant threat. Accidental implantation varies from single lesions to massive involvement of disruptive skin disorders (e.g. eczema).
    Accidental implantation is one of the most common adverse events following primary vaccination. It is far less common after revaccination but the threat of transfer to contacts remains.
     One or a few lesion: No specific treatment is required.
    Multiple lesions: Vaccinia Immune Globulin (VIG): 0.6 mg/kg
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
  • VACCINATION COMPLICATIONS: Auto-inoculation
    Inadvertent inoculation, accidental spread from vaccination site to another site on the body, usually occurs via auto-inoculation: .
    Photo on the right is an accidental auto-inoculation of cheek with vaccinia virus, approximately 5 days old. Primary take on arm, 10-12 days old. Photo on the left is an accidental auto-inoculation of lower eyelid with vaccinia virus in a woman.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    VACCINATION COMPLICATIONS: Auto-Inoculation
    Secondary infection of the cornea in a 12 year old male, post-vaccination reaction (CDC, date unknown).
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
  • ADVERSE VACCINATION REACTIONS: Vaccinia Keratitis
    OVERVIEW: Lesions of the cornea secondary to implantation of vaccinia are potentially threatening to eyesight. Corneal abrasion, ulceration and subsequent clouding may result in significantly impaired vision.
    FREQUENCY: The frequency of vaccinia keratitis is unknown. From the experience of those who cared for patients with vaccinia keratitis and from published reports, it is not a common occurrence. 
    CLINICAL: One week to 10 days after implantation, a central, grayish, disciform corneal lesion can be seen. (Often there are accompanying or preceding palpebral or periorbital vaccinations). With periorbital or mucosal involvement there may be considerable pruritus, leading to further rubbing of the eye and continued spread of the virus.
    Slit-lamp examination is best for defining the early stages, as well as following the course of disease and response to treatment. As the infection progresses a deeper ring-like lesion appears in the cornea. There may be uveal involvement and Descemet’s membrane may be infected. In some instances, more distal parts of the cornea may be involved. The corneal lesions appear crater-like and are indurated, edematous and infiltrated.
    A late manifestation, occurring as a result of natural healing, or because of the administration of VIG (which is contraindicated), is extensive cloudiness in the region of the original lesion.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • ADVERSE VACCINATION REACTIONS: Bacterial Infections
    Staphylococci and streptococci would be the most likely organisms to be encountered in normal individuals. Occasionally, enteric or anaerobic organisms are the cause of bacterial super-infection of vaccinations. The use of occlusive dressings, especially those tightly bound to the skin, may result in increased maceration of the skin. Occlusive dressings may also lead to more frequent occurrence of infection, the possibility of anaerobic infection, and more serious disease.
    FREQUENCY: The actual frequency of bacterial infections is unknown. Infants and young children experience this adverse event more commonly, in part because of unfettered scratching of the vaccination site and, in some instances, unsanitary behavior. In some of the more serious viral complications, bacterial superinfection may also occur as a consequence of both the necrotic tissue and the immune deficiency of the vaccinee.
    DIAGNOSIS: Clinical recognition is the mainstay of diagnosis, confirmed by appropriate bacterial cultures.
    MANAGEMENT: Appropriate antimicrobial therapy is required, selected on the basis of anticipated etiology and the results of culture and sensitivities. The area should be kept clean and debrided as appropriate. A loose dressing and topical antimicrobials may prevent spread and potentially hasten healing.
    In the immunologically deficient, appropriate replacement therapy should be used. For antibody deficiencies, immune globulin is appropriate and current therapy for phagocytic disorders is indicated. Consultation with infectious diseases and immunology experts is advised. Notification of the CDC is required. 
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • ADVERSE VACCINATION REACTIONS: Generalized Vaccinia
    Generalized vaccinia is the result of the systemic spread of virus from the vaccination site. Despite the appearance of the lesions, it is a totally benign complication of primary vaccination. Its frequency is not known, but it is believed to be rare. 
    The literature is confusing as this term has been used to describe this benign event as well as more serious and even lethal complications (eczema vaccinatum, other implantations, and progressive vaccinia). The term “generalized vaccinia” as used here will refer only to the rare, benign complication itself.
    PATHOGENESIS: The mechanisms underlying apparent viremic spread from a primary vaccination site to other parts of the body are not known. Virus is present in the blood, but clinically only the skin appears to be a target for implantation. The fact that recurrent episodes are seen in some individuals lends credence to an immunologic defect. Antibody deficiency is likely because the lesions result from viremia, which is normally controlled by antibodies. Also, each of the lesions, as well as the primary, heals without incident and in normal fashion, suggesting that cell-mediated immunity is intact.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
  • VACCINIA COMPLICATIONS: Generalized Vaccinia
    CLINICAL: Within a week after the onset of a vaccination reaction, lesions appear on unimmunized skin and appear to derive from viremia, not inoculation by transfer. Each takes the form of a primary vaccination, but is usually much smaller in size, and undergoes rapid evolution to scarring.
    Lesions may occur on any part of the body, most often on the trunk and abdomen, less commonly on the face and limbs. Lesions may occur on the palms and soles. In rare cases, a profuse rash occurs and may be confluent in nature. Rarely, lesions may recur at 4-6 week intervals for as long as one year.
    MANAGEMENT: Most instances of generalized vaccinia, particularly if the lesions are few, require no specific therapy. In some cases, with extensive lesions, or in recurrent disease, Vaccinia Immune Globulin (VIG) should be administered in an initial dose of 0.6 ml per kg body weight. Rarely is it necessary to administer more than one course with recurrent disease.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
  • ADVERSE VACCINATION REACTIONS: Eczema Vaccinatum
    OVERVIEW: Individuals with atopic dermatitis (eczema) are at special risk from implantation of vaccinia virus into the diseased skin, sometimes with a fatal outcome. Atopic dermatitis implies both a skin abnormality and an immunologic difference, ill defined, in individuals subject to this disease.
    If smallpox is not an immediate risk, vaccination should not be performed in these patients and they should not be in contact with vaccinees. If there is smallpox in the community with potential exposure, or if the patient is a household contact of a case, then vaccination must be performed.
    Transfer of vaccinia virus can occur from autoinoculation or from contact with a vaccinee whose lesion is in the florid stages. With early recognition and appropriate use of Vaccinia Immune Globulin (VIG), mortality can be reduced to zero, and morbidity alleviated.
    FREQUENCY: It is estimated that there are 27 million individuals in the United States in 2002 who have atopic dermatitis, many of whom would be susceptible to eczema vaccinatum if vaccinated or in contact with a vaccinee. 
    Further, it appears that even healed skin is not normal, and eczema vaccinatum has occurred in the skin of such individuals at the sites of prior florid eczema.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • VACCINIA COMPLICATIONS: Eczema Vaccinatum
    CLINICAL: The individual lesions appear identical to a primary vaccination and undergo identical evolution. Because most individuals have large contiguous patches of skin in the affected areas, confluent lesions are the rule. These often cover the entire face, antecubital fossa or behind the knee in the popliteal fossa. Confluent lesions may also appear on other areas of the body. Individual lesions may occur as a result of autoinoculation after the initial transfer, or by viremic spread.
    TREATMENT: Eczema vaccinatum demands urgent treatment with Vaccinia Immune Globulin (VIG). Mortality has generally been prevented if patients are treated promptly and adequately. However, even if there is a delay in recognition, prompt institution of VIG should be undertaken.
    Normally, the initial dose of intramuscular VIG (IM-VIG) is 0.6-1.0 ml per kg body weight. However, if the lesions are extensive when first seen, as much as 5-10 ml per kg of IM-VIG, divided into multiple doses, and given over several days.
    With bacterial infection, appropriate antibiotic treatment should be guided by most probable organisms (staphylococcus aureus, streptococci, and enteric bacteria) and subsequently by results of culture and sensitivity. Fungal infections should be treated by the appropriate antifungal agent. It is recommended that an infectious disease specialist be consulted. For treatment of the underlying atopic dermatitis, a dermatologist should be consulted.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • ADVERSE VACCINATION REACTIONS: Progressive Vaccinia
    OVERVIEW: Progressive vaccinia is the most severe complication of smallpox vaccination. It is almost always life threatening. 
    The term “Progressive Vaccinia” is the preferred designation for this complication although, in the past, it has sometimes been termed:
    • Vaccinia necrosum
    • Vaccinia gangrenosa
    • Disseminated vaccinia
    FREQUENCY: Rare in the past, it may be a greater threat today, given the larger proportion of susceptible persons in the population with immunodeficiency whether it is:
    congenital/acquired (e.g.., leukemia or lymphoma),
    iatrogenic (e.g.., chemotherapy or glucocorticoid treatment), or
    HIV induced.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    VACCINIA COMPLICATIONS: Progressive Vaccinia
    PATHOGENENSIS: Progressive vaccinia occurs because of an immune defect in the vaccinated individual or in a susceptible contact of a vaccinee. Nearly all instances have been in those with a defined cell-mediated immune (CMI) defect (T-cell deficiency).
    The virus multiplies by cell-to-cell spread at the primary vaccination site causing the lesion to expand circumferentially. Necrotic skin remains in the central lesion behind the advancing edge. Virus gains entry into the blood (viremia) at an early stage in patients with nearly totally deficient immune systems and implants in distant skin sites and in multiple organs. Secondary skin lesions follow the same pattern as the primary vaccination, each expanding in situ.
    Local and systemic bacterial infection can ensue with progressive disease. Untreated or unsuccessfully treated patients succumb in what appears to be toxic or septic shock. Postinfectious encephalitis, which is rare (3 cases per million vaccinees) but can be fatal in 15 to 25% of those, and can leave 25% with permanent neurologic sequelae.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
    [Photograph of Progressive Vaccinia, which was fatal, in a child with an immunodeficiency. From Fenner F., Henderson DA, et al. Smallpox and its Eradication. WHO. 1988].
  • <number>
    Evolution of Progressive Vaccinia:
    (1) Primary vaccination site does not heal
    (2) Lesion is 
    •Ulcerative
    •Vesiculo-pustular with central necrosis
    (3) Lesion expands circumferentially with extensive necrosis
    (4) Viremic or secondary inoculation lesions undergo same evolution with massive involvement.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    Evolution of Progressive Vaccinia (con’t.):
    (5) Coalescent lesions cover large portions of body with extensive destruction of normal tissue
    (6) Normally there is no 
    •Lymphadenopathy
    •Splenomegaly or 
    •Other signs of inflammatory response 
    (7) If allowed to progress, patient may experience: 
    •Toxic or septicemic shock/disseminated intravascular coagulation
    •Superimposed systemic fungal symptoms 
    •Parasitic infection symptoms
    •Bacterial infections, bacteremia, septicemia
    (8) If viable unmatched lymphocytes have been administered, graft-versus-host disease may occur, with splenomegaly, hepatomegaly, skin rash, DIC and signs of inflammatory response to vaccination sites.
    Sources:
    CDC Smallpox Vaccination and Adverse Events Training Module, available online at:
    http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/vac_method.html.
    CDC smallpox website: http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp.
    Henderson DA, et al. Consensus Statement: “Smallpox as a Biological Weapon: Medical and Public Health Management.” JAMA. 1999; 281: 2127 – 2137.
    Wang F. Harrison’s Principles of Internal Medicine, McGraw-Hill, NYC, 1998, Chapter 188.
  • <number>
    For additional information on this presentation, smallpox or other biological agents, contact:
    Anthony J. Carbone, MD, MS, MPH
    The Harvard Center For Public Health Preparedness
    Harvard School of Public Health
    651 Huntington Avenue, FXB Center 7th Floor
    Boston, Massachusetts 02115
    Tel: 617-432-4529
    E-Mail: acarbone@hsph.harvard.edu
  • Smallpox pre-vax training 022603.ppt

    1. 1. Phase 1 Pre-vaccination Training February 26, 2003 MaineMaine Public Health Response TeamPublic Health Response Team
    2. 2. Office of Public Health Emergency Preparedness Anthony J. Tomassoni, MD, MS, FACEP, DACMTAnthony J. Tomassoni, MD, MS, FACEP, DACMT Medical DirectorMedical Director 287.7312287.7312 Anthony.Tomassoni@Maine.govAnthony.Tomassoni@Maine.gov Steven Trockman, MPH, CHESSteven Trockman, MPH, CHES CoordinatorCoordinator 287.8104287.8104 Steven.Trockman@Maine.govSteven.Trockman@Maine.gov Janet AustinJanet Austin Planning & Research Associate IIPlanning & Research Associate II 287.7310287.7310 Janet.Austin@Maine.govJanet.Austin@Maine.gov
    3. 3. Phase 1 Pre-vaccination Objectives  Explain need for public health andExplain need for public health and hospital smallpox response teamshospital smallpox response teams  Assess smallpox vaccination risks andAssess smallpox vaccination risks and screen for contraindicationsscreen for contraindications
    4. 4. Phase 1 Pre-vaccination Objectives  Describe smallpox vaccinationDescribe smallpox vaccination administration procedureadministration procedure  Define how to care for smallpoxDefine how to care for smallpox vaccination sitevaccination site  Identify the “take” after vaccinationIdentify the “take” after vaccination
    5. 5. Phase 1 Pre-vaccination Objectives  Recognize smallpox vaccinationRecognize smallpox vaccination common and serious adverse reactionscommon and serious adverse reactions  Explain the procedures for reportingExplain the procedures for reporting adverse reactions and receiving careadverse reactions and receiving care  List vaccination plan next stepsList vaccination plan next steps
    6. 6. CDC VIDEO SMALLPOXSMALLPOX Vaccine AdministrationVaccine Administration 37:12 minutes37:12 minutes
    7. 7. Need for public health and hospital smallpox response teams
    8. 8. Smallpox Smallpox is a severe, febrile, contagious,Smallpox is a severe, febrile, contagious, sometimes fatal disease caused by the virussometimes 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.
    9. 9. 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
    10. 10. 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 inRoutine smallpox vaccination discontinued in America in 1971; not required forAmerica in 1971; not required for international travel since 1981.international travel since 1981.
    11. 11. Diagnosis and Management of Smallpox NEJM 346;17:1300-1308 April 25, 2002 Joel G. Breman, MD, DTPH, and D.A. Henderson, MD, MPH
    12. 12. Last Case of Variola Major in the World Rahima BanuRahima Banu Bhola Island, October 16, 1975Bhola Island, October 16, 1975
    13. 13. Terrorist Smallpox Event A case of smallpox anywhere in theA case of smallpox anywhere in the worldworld ““The discovery of a single suspectedThe discovery of a single suspected case of smallpox must be treated ascase of smallpox must be treated as an international health emergencyan international health emergency and be brought immediately to theand be brought immediately to the attention of national officials throughattention 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.
    14. 14. Smallpox TREATMENT  Vaccinia vaccination by the 4Vaccinia vaccination by the 4thth dayday of exposure.of exposure.  No specific anti-viral therapyNo specific anti-viral therapy proven effective in clinicalproven effective in clinical smallpox disease.smallpox disease.
    15. 15. Vistide® (cidofovir)  Cidofovir unknownCidofovir unknown benefit against smallpoxbenefit against smallpox  Toxic side-effectsToxic side-effects  Not FDA approved forNot FDA approved for use in treatment ofuse in treatment of smallpoxsmallpox
    16. 16. ME smallpox vaccination plan
    17. 17. General Concepts  Vaccination targeted to Public HealthVaccination targeted to Public Health Smallpox Response Teams and hospital-Smallpox Response Teams and hospital- based Healthcare Smallpox Responsebased Healthcare Smallpox Response TeamsTeams  Sites established considering populationSites established considering population density, hospital clusters, judicious use ofdensity, hospital clusters, judicious use of vaccine, vaccine security, and accessibilityvaccine, vaccine security, and accessibility
    18. 18. Calendar  11/21/02 Request to states for pre-event and11/21/02 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 invites12/26/02 Maine Bureau of Health invites volunteers for Phase 1 - Public Healthvolunteers for Phase 1 - Public Health Response TeamsResponse Teams
    19. 19. Arrival in ME: Jan. 28
    20. 20. Calendar: screening  2/18/03 Smallpox volunteers receive email2/18/03 Smallpox volunteers receive email pre-vaccination screening instructionspre-vaccination screening instructions  2/19/03 Workplace Health screening starts2/19/03 Workplace Health screening starts
    21. 21. VACCINE CONTRAINDICATIONS  Eczema or atopic dermatitisEczema or atopic dermatitis  Active skin conditionsActive skin conditions  Weakened immune systemWeakened immune system  PregnancyPregnancy  Eye diseaseEye disease
    22. 22.  Serious allergic reaction to a prior dose ofSerious allergic reaction to a prior dose of DryvaxDryvax®® vaccine or vaccine componentvaccine or vaccine component  polymyxin Bpolymyxin B  streptomycinstreptomycin  tetracyclinetetracycline  neomycinneomycin  phenolphenol VACCINE CONTRAINDICATIONS
    23. 23. VACCINE CONTRAINDICATIONS  Eczema/Atopic Dermatitis:Eczema/Atopic Dermatitis:  Rash involves flexuresRash involves flexures  Two of the following:Two of the following: Rash started before age 5Rash started before age 5 Personal history of allergies (food/env)Personal history of allergies (food/env) or asthmaor asthma First degree relative with atopicFirst degree relative with atopic dermatitisdermatitis
    24. 24. VACCINE CONTRAINDICATIONS  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
    25. 25. Smallpox Vaccine NYC Board of HealthNYC Board of Health Live Vaccinia VirusLive Vaccinia Virus DryvaxDryvax®® Wyeth LaboratoriesWyeth Laboratories
    26. 26. VACCINE INDICATIONS People who have beenPeople who have been directly exposeddirectly exposed to theto the smallpox virus should get thesmallpox virus should get the vaccinevaccine,, regardless of theirregardless of their health statushealth status..
    27. 27. 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 enablingAntigenic 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 bodyVaccinia virus may cause rash, fever, and head and body aches. In certain groups of people, complications fromaches. In certain groups of people, complications from the vaccinia virus can be severethe vaccinia virus can be severe..
    28. 28. Vaccinia: “Live Virus” Vaccine  Contains a "living" virus that is able to giveContains a "living" virus that is able to give and produce immunity, usually withoutand produce immunity, usually without causing illnesscausing illness  Care of the site important to preventCare of the site important to prevent transmission to other parts of the body or totransmission to other parts of the body or to other peopleother people  Live virus vaccines effective and safe for mostLive virus vaccines effective and safe for most people with healthy immune systemspeople with healthy immune systems  Sometimes experience mild symptoms post-Sometimes experience mild symptoms post- vaccinationvaccination  Other live virus vaccines: measles, mumps,Other live virus vaccines: measles, mumps, rubella, chickenpoxrubella, chickenpox
    29. 29. 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 10Revaccination recommended every 10 years for continued protection.years for continued protection.  Stable antibodies during a 30-year periodStable antibodies during a 30-year period in vaccinees at birth, age 8 and 18 years.in vaccinees at birth, age 8 and 18 years.
    30. 30. Smallpox Vaccination: Immunity  Vaccination within 3 days of exposure willVaccination within 3 days of exposure will prevent or significantly lessen the severityprevent or significantly lessen the severity of smallpox symptoms in the vast majorityof smallpox symptoms in the vast majority of people.of people.  Vaccination 4 to 7 days after exposureVaccination 4 to 7 days after exposure likely offers some protection from diseaselikely offers some protection from disease or may modify the severity of disease.or may modify the severity of disease.
    31. 31. Calendar: training  2/26/03 Phase 1 Pre-vaccination training (22/26/03 Phase 1 Pre-vaccination training (2 hours)hours)  Second session date TBD (makeup ifSecond session date TBD (makeup if needed)needed)
    32. 32. Phase 1 Vaccination  Clinics 3/3 and 3/6 (makeup/overflow)Clinics 3/3 and 3/6 (makeup/overflow)
    33. 33. Smallpox Vaccination Method Multiple Puncture Vaccination Using Bifurcated NeedleMultiple Puncture Vaccination Using Bifurcated Needle
    34. 34. Step-by-Step Method for Vaccination 1. Skin Preparation: None.1. Skin Preparation: None. **Under no circumstancesUnder no circumstances should alcohol be appliedshould alcohol be applied to the skin prior toto the skin prior to vaccinationvaccination **
    35. 35. Step-by-Step Method for Vaccination 2. Dip Needle2. Dip Needle The 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 ofThe needle is designed to hold a minute drop of vaccine of sufficient size and strength to ensure a take if properlysufficient size and strength to ensure a take if properly administered.administered.
    36. 36. Step-by-Step Method for Vaccination 3. Make 15 perpendicular insertions3. Make 15 perpendicular insertions within a 5mm diameter area.within a 5mm diameter area.
    37. 37. Step-by-Step Method for Vaccination 4. Absorb excess vaccine.4. Absorb excess vaccine.
    38. 38. Cover site with sterile dressing
    39. 39.  Virus can be recovered at site from time ofVirus 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 byNormal bathing can occur if covered by waterproof bandagewaterproof bandage Vaccination Site Care
    40. 40. Vaccination Site Care  Cover the vaccination site loosely with a gauzeCover the vaccination site loosely with a gauze bandage.bandage.  Wear long-sleeved shirt that covers theWear long-sleeved shirt that covers the vaccination site.vaccination site.  Change the bandage every 1-2 days. DiscardChange 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 orHand washing after any contact with bandage or sitesite
    41. 41. Vaccination Site Care Keep the vaccination site dry.Keep the vaccination site dry. Put the contaminated bandages in a sealed plasticPut 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 inWash 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 aWhen the scab comes off, throw it away in a sealed plastic bag.sealed plastic bag.
    42. 42. Vaccination Site Care  DoDo notnot use a bandage that blocks all air from theuse a bandage that blocks all air from the vaccination site. This may cause the skin at thevaccination 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 toUse loose gauze secured with medical tape to cover the site.cover the site.  DoDo notnot put salves or ointments on the vaccinationput salves or ointments on the vaccination site.site.  DoDo notnot scratch or pick at the scab.scratch or pick at the scab.
    43. 43. Vaccinia: Vaccination Site ““Major Reaction” (vs. “EquivocalMajor Reaction” (vs. “Equivocal Reaction”)Reaction”)
    44. 44.  First VaccinationFirst Vaccination  Vesicular or pustular lesionVesicular or pustular lesion  Area of definite palpable indurationArea 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
    45. 45.  RevaccinationRevaccination  Less pronounced and more rapidLess pronounced and more rapid progressionprogression  Pustular lesion or indurationPustular lesion or induration surrounding a central crust or ulcersurrounding a central crust or ulcer WHO Expert Committee on Smallpox, 1964 Clinical Response to Vaccination
    46. 46.  Swelling and tenderness of axillarySwelling and tenderness of axillary lymph nodes, usually during 2lymph nodes, usually during 2ndnd weekweek  Fever and malaise commonFever and malaise common Major Reaction
    47. 47. Normal Reaction Day 7
    48. 48. Normal Reaction Day 12
    49. 49. Major Reaction First time vaccinee, Day 10
    50. 50. Major Reaction First time vaccinee, Day 15
    51. 51. Major Reaction Revaccinee, Day 4
    52. 52. Major Reaction Revaccinee, Day 8
    53. 53. Major Reaction Revaccinee, Day 10
    54. 54. Major Reaction Revaccinee, Day 15
    55. 55.  FatigueFatigue  HeadacheHeadache  MyalgiaMyalgia  LymphadenopathyLymphadenopathy  LymphangitisLymphangitis  PruritisPruritis  Edema at the vaccination siteEdema at the vaccination site  Satellite LesionsSatellite Lesions Expected Range of Vaccine Reactions
    56. 56. 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%)  FeverFever ≥≥ 37.737.7 ºC or 100 ºF (10%)ºC or 100 ºF (10%)
    57. 57. 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 toPhysically unable to work due to systemic signs and symptomssystemic signs and symptoms  Extensive skin lesions or vaccination siteExtensive skin lesions or vaccination site that can not be coveredthat can not be covered  HCWs do not adhere to infection controlHCWs do not adhere to infection control precautions and recommendationsprecautions and recommendations
    58. 58. 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)
    59. 59. US Military Data as of 2/12/03  DoD healthcare workers vaccinated againstDoD healthcare workers vaccinated against smallpox: More than 8,000smallpox: More than 8,000  DoD operational forces vaccinated againstDoD operational forces vaccinated against smallpox: Well over 100,000smallpox: Well over 100,000
    60. 60. 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 toTransfer of vaccinia virus to contactscontacts 0 cases0 cases Treatments with (VIG)Treatments with (VIG) 0 cases0 cases Deaths due to smallpoxDeaths due to smallpox vaccinationvaccination 0 cases0 cases
    61. 61. Smallpox Vaccine Adverse Reactions  Nonspecific dermatological conditionsNonspecific 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  OtherOther  Not yet characterizedNot yet characterized
    62. 62. Vaccinia: Adverse Reactions The most frequent adverseThe most frequent adverse complication of vaccination iscomplication of vaccination is inadvertent inoculationinadvertent inoculation at otherat other sites.sites.
    63. 63. Inadvertent Inoculation  Transfer of vaccinia virus from vaccination siteTransfer 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 smallpoxMost 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 followLesions contain vaccinia virus and follow vaccination coursevaccination course
    64. 64. Adverse Vaccination Reactions Accidental ImplantationAccidental Implantation
    65. 65. Inadvertent Inoculation  Hand washing after contact with vaccinationHand washing after contact with vaccination site or contaminated material most effectivesite 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 veryRisk factors: disruption of epidermis or very youngyoung  VIG may speed recovery if extensive or severeVIG may speed recovery if extensive or severe manifestation (e.g., significant pain)manifestation (e.g., significant pain)
    66. 66. Nonspecific rash following smallpox vaccination Vaccination site Photo credit: J. Michael Lane, MD MPH CDC Teaching slide set Adverse reactions following smallpox vaccination
    67. 67. Nonspecific Rashes  Flat, erythematous, macules or patches, andFlat, erythematous, macules or patches, and generalized urticarial rashesgeneralized urticarial rashes  Usually do not become vesicularUsually do not become vesicular  Onset ~ 10 days post-vaccinationOnset ~ 10 days post-vaccination  Afebrile patient, well appearingAfebrile patient, well appearing  Spontaneously resolves ~2-4 daysSpontaneously resolves ~2-4 days  Immune response vs. viral replicationImmune response vs. viral replication  AntipruriticsAntipruritics
    68. 68. Nonspecific rash following smallpox vaccination Photo credit: Vaccination reactions in vaccinia-naive volunteers in a clinical study of diluted Dryvax® enrolled in NIAID VTEUs
    69. 69. Photo credit: V. Fulginiti, MD and Logical Images http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm ERYTHEMA MULTIFORME
    70. 70. Adverse Vaccination Reactions Auto-inoculationAuto-inoculation
    71. 71. 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 anShould be managed in consultation with an ophthalmologistophthalmologist  Treatment may include topical ophthalmicTreatment may include topical ophthalmic topical antiviral agents, topical steroidstopical antiviral agents, topical steroids and topical antibacterials and VIGand topical antibacterials and VIG
    72. 72. Secondary Corneal Infection
    73. 73. Adverse Vaccination Reactions Vaccinia KeratitisVaccinia Keratitis
    74. 74. Adverse Vaccination Reactions Bacterial InfectionsBacterial Infections
    75. 75. Adverse Vaccination Reactions Generalized VacciniaGeneralized Vaccinia
    76. 76. Vaccination site Regional form Sometimes resembles Smallpox Photo credit: J. Michael Lane, MD MPH CDC Teaching slide set Adverse reactions following smallpox vaccination GENERALIZED VACCINIA
    77. 77. Adverse Vaccination Reactions Generalized vacciniaGeneralized vaccinia
    78. 78. Adverse Vaccination Reactions Eczema VaccinatumEczema Vaccinatum
    79. 79. Multiple umbilicated EV papular lesions Healed EV EV predilection for sites of atopic dermatitis (eczema) Photo credit: V. Fulginiti, MD, H. Kempe MD and Logical Images http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm
    80. 80. Adverse Vaccination Reactions Eczema vaccinatumEczema vaccinatum
    81. 81. Adverse Vaccination Reactions Progressive VacciniaProgressive Vaccinia ““Vaccinia Necrosum/Gangrenosa”Vaccinia Necrosum/Gangrenosa” ““Disseminated Vaccinia”Disseminated Vaccinia”
    82. 82. Adverse Vaccination Reactions Progressive VacciniaProgressive Vaccinia
    83. 83. Photo credit: J. Michael Lane, MD MPH CDC Teaching slide set Adverse reactions following smallpox vaccination Atypical PV in 64yo with lymphoma and IgA, IgM and IgA deficiency Severe Take Severe take
    84. 84. Progressive vaccinia Photo credit: V. Fulginiti, MD and Logical Images http://www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm SCID HypogammaglobulinemiaLymphosarcoma Lymphoma and PV
    85. 85. FETAL VACCINIA Photo credit: J. Michael Lane, MD MPH CDC Teaching slide set Adverse reactions following smallpox vaccination
    86. 86. Fetal vaccinia Photo credit: J. Michael Lane, MD MPH CDC Teaching slide set Adverse reactions following smallpox vaccination
    87. 87. 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
    88. 88. Reporting Adverse Events Following Smallpox Vaccine  Report – clinically significant or unexpected AesReport – clinically significant or unexpected Aes  When – clinically significant/unexpected AEs withinWhen – clinically significant/unexpected AEs within 48 hours and other AEs within 7 days48 hours 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
    89. 89. Next steps  Voluntary program: determine your riskVoluntary program: determine your risk  Vaccination clinics next weekVaccination clinics next week  Post-vaccination trainingPost-vaccination training  Phase 2 vaccinationsPhase 2 vaccinations  Prepared for mass vaccination (if event)Prepared for mass vaccination (if event)
    90. 90. 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)
    91. 91. Calendar: Post-vax training  Phase 1 Post-vaccination training (6Phase 1 Post-vaccination training (6 hours) on 3/20hours) on 3/20  Identify and prioritize roles of publicIdentify and prioritize roles of public health response team member:health response team member: In event of smallpox exposureIn event of smallpox exposure event: (4 hours)event: (4 hours) As member of vaccination team:As member of vaccination team: (two 1-hour workshops)(two 1-hour workshops)
    92. 92. Calendar: Phase 2 schedule  To be determinedTo be determined
    93. 93. For More Information  CDC Smallpox websiteCDC Smallpox website www.cdc.gov/smallpoxwww.cdc.gov/smallpox  National Immunization Program websiteNational Immunization Program website www.cdc.gov/nipwww.cdc.gov/nip
    94. 94. Acknowledgements: sources for slides and materials  Anthony J. Carbone, MD, MS, MPHAnthony 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 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.
    95. 95. Acknowledgements: Anthony J. Tomassoni, MD, MS, FACEP, DACMTAnthony J. Tomassoni, MD, MS, FACEP, DACMT Medical DirectorMedical Director OPHEPOPHEP Jo E. Linder, MDJo E. Linder, MD Medical Officer, Southern RegionMedical Officer, Southern Region HHSD/Portland Public HealthHHSD/Portland Public Health
    96. 96. Thank You for Volunteering!

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