Maines Smallpox Health Care Response Team PreEvent Immunization Program

1
Maines SmallpoxHealth Care Response
TeamPre-Event Immunization Program

• Maine Department of Human Services
• Bureau of Health

2
Background

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

3
small pockes

• pocke sac

4
Why should we fear smallpox?

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

5
Smallpox Repositories

• Atlanta, Georgia, USA Kotsovo,
  Novosibirsk, Russia

6
BIOPREPARAT

• Established in 1973
• 40,000 workers
• 9000 scientists
• 47 facilities
• 18 research institutes
• 6 production facilities
• Siberian storage complex

7
BIOPREPARAT

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

8
Iraqi BW Program
All key aspectsRD, production, and
weaponizationof Iraq's offensive BW program are
active and most elements are larger and more
advanced than they were before the Gulf war.
9
The response to the threat

• Surveillance
• Prevention
• Vaccination

10
Dryvax Learning Objectives 1

• To help train practitioners to screen potential
  vaccinees and their household contacts for
  contraindications to smallpox vaccine
• To review contraindications to smallpox vaccine,
  including contraindications in potential
  vaccinees and in household contacts
• To aid individuals in self-screening preparatory
  to volunteering for screening and vaccination

11
Dryvax Learning Objectives 2

• To become familiar with the method of vaccine
  administration
• To learn proper vaccination site care designed to
  reduce the potential for adverse reactions
  including transmission of the vaccinia virus to
  others
• To learn about normal reactions to vaccination
• To learn about adverse reactions that may result
  from vaccination, and to understand the
  importance of rapid reporting and follow-up of
  possible adverse reactions

12
The Smallpox Vaccine

• Vaccine contains live vaccinia virus
• This is NOT the smallpox (variola) virus
• Vaccine virus can be transmitted to household and
  other close contacts
• Candidates for vaccination must be carefully
  screened for contraindications
• Certain medical conditions in the person's
  household contacts must also be considered as
  contraindications for vaccination

13
Smallpox VaccineContraindications and
Precautions 1 (Non-emergency Situations)

• Individuals who have any of the following
  conditions should NOT get the smallpox vaccine
  unless they have been exposed to the smallpox
  virus
• Serious allergic reaction to a prior dose of
  vaccine or vaccine component
• Moderate or severe acute illness
• Breastfeeding

14
Contraindications and Precautions
2(Non-emergency Situations)

• Individuals who have any of the following
  conditions, or live with someone who does, should
  NOT get the smallpox vaccine unless they have
  been exposed to the smallpox virus
• Eczema or atopic dermatitis (current or past
  history) in the recipient or household contact
  (This is true even if the condition is not
  currently active, mild or experienced as a
  child.)
• Acute, chronic, or exfoliative skin conditions
  (until improved or resolved) in the recipient or
  household contact
• Immunosuppression in the recipient or household
  contact
• Pregnancy in the recipient or household contact
• Children lt12 months of age

15
New ContraindicationCardiac Disease

• People With Known Cardiac Disease Should Not Be
  Vaccinated
• CDC has received reports of cardiac events
  following smallpox vaccinations.
• Association between smallpox vaccination and
  cardiac events is unclear
• CDC recommends that persons with known cardiac
  disease (e.g., cardiomyopathy, previous
  myocardial infarction, history of angina, or
  other evidence of coronary artery disease) not be
  vaccinated as response team members in the
  smallpox pre-event vaccination program at this
  time.

16
Cardiac Contraindications continued

• This exclusion may be removed as more information
  becomes available.
• Vaccination of other persons should be continued
  as planned.
• Data from recent smallpox vaccinations have been
  found to be consistent with a causal association
  between vaccination and myopericarditis.

17
Civilian Vaccinations

• Persons receiving vaccine should be informed that
  myopericarditis is a potential complication
• Seek medical attention if chest pain, shortness
  of breath, or other symptoms of cardiac disease
  within two weeks after vaccination.
• 25,645 persons vaccinated as of 3/21/03
• 7 adverse events of cardiac origin reported.
• 2 cases of myopericarditis
• 3 acute myocardial infarctions
• 2 cases of angina without myocardial infarction.
  One of the patients with myocardial infarction
  died.

18
Civilian Vaccinations continued

• No clustering of events in time after
  vaccination. Onsets from 2 to 17 days after
  vaccination (median 5 days).
• 5 additional vaccinees have been evaluated for
  chest pain, no evidence of cardiac involvement
• Background death rate age distribution of
  vaccinated persons and age-specific, all-cause
  mortality rates
• 2 deaths by chance alone within 3 weeks of
  vaccination among persons 45-54 years of age
• 2 to 3 deaths among vaccinees 55-64 years of age
• Among persons 45-64 years of age, 1 death due to
  cardiac causes is expected to occur within 3
  weeks of vaccination among the persons in this
  age group vaccinated in the civilian program

19
Military Vaccinations

• 10 cases of myopericarditis reported among
  several hundred thousand recent U.S. military
  vaccinees.
• Diagnoses based on clinical, laboratory, EKG
  and/or echocardiographic evidence of myocardial
  or pericardial inflammation.
• None of the cases have been clinically severe,
  and all the patients are reported to have
  recovered fully.
• Onset 6 to 12 days following vaccination
• No cases of myocarditis or pericarditis among
  100,000 re-vaccinees
• Myocarditis reported previously following
  smallpox vaccination in Europe, but had not been
  a well-recognized complication following
  vaccination with the U.S.-licensed New York City
  Board of Health vaccine.

20
Smallpox Vaccine Components

• The current vaccine, Dryvax, contains
• polymyxin B
• streptomycin
• tetracycline
• neomycin
• phenol
• Newer vaccines (not yet available for use) made
  from tissue cultures will not contain antibiotics

21
Screening for Eczema and Atopic Dermatitis

• Questions and Information
• Have you or any member of your household EVER
  been diagnosed with eczema or atopic dermatitis?
• Eczema/atopic dermatitis usually is itchy, red,
  scaly rash that lasts more than 2 weeks and comes
  and goes
• If you or household member EVER had a rash like
  this (EVEN LONG AGO), you should NOT receive
  smallpox vaccine

22
Screening for Eczema- considerations

• Onset of rash at age lt 5 years
• Atopy (hayfever, food allergies, asthma)
• In anyone who has ever had eczema, skin
  sensitivity persists even after rash is healed
• Isolated hand numular eczema may not
  necessarily be contraindications
• If in doubt, consult a dermatologist and the
  CDCs Clinician Information Line at 877-554-4625.

23
Some Causes of Immunosuppression

• Leukemia
• Lymphoma
• Generalized malignancy
• Solid organ or stem cell transplantation
• Therapy with immunosuppressive drugs
• Humoral or cellular immunity disorders
• HIV infection

24
Screening for Pregnancy

• In pre-event setting, should NOT be given to
• pregnant women
• women trying to become pregnant
• Educate women of child-bearing age about fetal
  vaccinia
• Advise avoidance of pregnancy for 4 weeks
  following vaccination

25
Screening for Pregnancy

• If pregnancy is a possibility, administer home
  test for pregnancy immediately prior to
  immunization first morning urine is best
• CDC has established a pregnancy registry for
  women who are pregnant while vaccinated

26
Clinical Response to Vaccination

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

WHO Expert Committee on Smallpox, 1964
27
Progression of smallpox vaccination site in a
non-immune person
28
Clinical Response to Vaccination

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

WHO Expert Committee on Smallpox, 1964
29
A Take the Major Reaction

• Presence of a Jennerian vesicle on day 6,7,or 8
  after vaccination
• Swelling and tenderness of axillary lymph nodes,
  usually during 2nd week
• Fever and malaise common

30
(No Transcript)
31
Equivocal Reaction

• All responses other than major reactions
• Caused by partial immunity, insufficiently potent
  vaccine, vaccination technique failure
• Vaccination should be repeated as soon as possible

32
Accidental Administration

• Oral or Parenteral
• Injection IM or SQ
• Ingestion
• These are not recommended routes of
  administration. No harm has been recorded from
  such events. 
• Management
• Follow clinically and examine the site of
  injection for any lesions x 1-2 weeks following
  administration. If the injection is subcutaneous,
  some individuals will respond with a normal
  cutaneous response.

33
Vaccination Site Care

• Virus can be recovered at site from time of
  papule until scab separates
• Site should be kept dry and covered
• Gauze semipermeable membrane for clinical
  workers during shifts
• Normal bathing can occur if covered by waterproof
  bandage

34
Video
35
Normal, Typically Mild Reactions

• These reactions usually go away without
  treatment.
• The arm receiving the vaccination may be sore and
  red where the vaccine was given.
• The glands in the armpits may become large and
  sore.
• The vaccinated person may run a low fever.
• One out of 3 people may feel bad enough to miss
  work, school, or recreational activities or have
  trouble sleeping.

36
Serious Reactions 1

• In the past, about 1,000 people for every 1
  million people vaccinated for the first time
  experienced reactions that, while not
  life-threatening, were serious. These reactions
  may require medical attention
• Inadvertent inoculation accidental spreading of
  the vaccinia virus caused by touching the
  vaccination site and then touching another part
  of the body or another person. It usually occurs
  on the genitals or face, including the eyes,
  where it can damage sight or lead to blindness.
  Washing hands with soap and water after touching
  the vaccine site will help prevent this.

37
Serious Reactions 2

• Generalized vaccinia A widespread vaccinia rash.
  The virus spreads from the vaccination site
  through the blood. Sores break out on parts of
  the body away from the vaccination site.
• Erythema multiforme A toxic or allergic rash in
  response to the vaccine that can take various
  forms.

38
Life-Threatening Reactions 1

• Rarely, people have had very bad reactions to the
  vaccine. In the past, between 14 and 52 people
  per 1 million people vaccinated for the first
  time experienced potentially life-threatening
  reactions. These reactions require immediate
  medical attention
• Eczema vaccinatum Serious skin rashes caused by
  widespread infection of the skin in people with
  skin conditions such as eczema or atopic
  dermatitis.
• Progressive vaccinia (or vaccinia necrosum)
  Ongoing infection of skin with tissue destruction
  frequently leading to death.
• Postvaccinal encephalitis Inflammation of the
  brain.

39
Life-Threatening Reactions 2

• People with certain medical conditionsincluding
  people with weakened immune systems or certain
  skin conditionsare more likely to have these
  reactions and should not get the smallpox vaccine
  unless they have been exposed to smallpox.
• Based on past experience, it is estimated that
  between 1 and 2 people out of every 1 million
  people vaccinated may die as a result of
  life-threatening reactions to the vaccine.

40
Where do the data originate?

• Statistical information about smallpox vaccine
  adverse reactions is based on data from two
  studies conducted in 1968.

41
Treatment for some adverse events may include

• Vaccinia Immune Globulin (VIG)
• First line therapy
• Cidofovir, an antiviral that has shown some
  experimental evidence of efficacy against pox
  viruses

42
Conclusion

• Adverse event rates in the United States today
  may be higher because there may be more people at
  risk from immune suppression (from cancer, cancer
  therapy, organ transplants, and illnesses such as
  HIV/AIDS) and eczema or atopic dermatitis.
  SCREENING IS INTENDED TO PREVENT VACCINATION OF
  THOSE WITH INCREASED RISK OF ADVERSE EVENTS.
• The outcome associated with adverse events may be
  less severe than previously reported because of
  advances in medical care. Rates may be lower for
  persons previously vaccinated.

43
Next steps

• Maines Smallpox Immunization Program Folder has
  been sent to facilitate requests for volunteers,
  screening and aftercare.
• Learn what you can about smallpox and the
  smallpox vaccine.
• If you are eligible for pre-event vaccination,
  additional training you will receive will help to
  prepare you for a role in your Health Care
  Response Team.

44
For More Information

• CDC Smallpox website
• www.bt.cdc.gov
• CDCs Clinician Information Line
• 877-554-4625
• National Immunization Program
• www.cdc.gov/nip

45
Acknowledgements

• Thank you for your participation in this
  presentation.
• Slides courtesy of the Centers for Disease
  Control and Prevention, The Harvard Center for
  Public Health Preparedness, and The Maine
  Department of Human Services, Bureau of Health.

46
Reconstitution of Dryvax Smallpox Vaccine

• As taken from the Product Insert,
• Dec. 2002

47
Smallpox Vaccine

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

48
1.Lift up tab of aluminum seal on vaccine vial.
DO NOT BREAK OFF OR TEAR DOWN TAB.
49
2.Wipe off vial stopper with an alcohol sponge
and allow to dry.
50
3. Place vaccine vial upright on a hard, flat
surface. Insert a sterile 21 gauge or smaller
needle into the rubber stopper to release the
vacuum from the vaccine vial. Discard the needle
in biohazard waste container. (This needle is
not included in the package)
51

• 4.To reduce viscosity of cold diluent, warm by
  holding diluent-cartridge in palm of hand for a
  minute or so.
• 5.Peel open the vented needle package (provided
  with the kit) and aseptically remove the vented
  needle.

52
6.Remove rubber cover from end of the diluent
syringe.
53
7.With a twisting motion, aseptically attach
the vented needle to the hub of the diluent
syringe.
54
8.Remove protective cover from the vented needle
and expel the air from the diluent syringe.
55
9.Aseptically insert the needle through the
rubber stopper into the vaccine vial up to the
first hub.
56
10.Depress the plunger to ensure the entire
volume of diluent is delivered into the vial.
57

• 11.Withdraw diluent syringe/vented needle and
  discard in biohazard waste container.
• 12.Allow vaccine vial to stand undisturbed for 3
  to 5 minutes. Then if necessary, swirl vial
  gently to effect complete reconstitution. Do
  not shake!

58

• 13. Record date of reconstitution.
• 14. Remove metal retaining ring and stopper from
  the vial.
• 15.Aseptically reserve stopper for re-use to
  re-seal the vial in case the vial of vaccine is
  not entirely consumed.
• 16. Store unused vaccine at 2-8 oC in a secured
  location until next use (expires 60 days after
  reconstitution).