1. Vaccinia Vaccine. Areas that will be covered in this discussion:
History of smallpox
Transmission and manifestations of smallpox
Current smallpox threat
Vaccinia (smallpox vaccine) side effects
Who should and should not receive vaccine
CDC recommendations for care of injection site
Questions for risk managers.

2. SMALLPOX
Highly contagious & sometimes fatal disease with no specific treatment.
Historically, overall fatality rate of about 30%.

3. TWO CLINICAL FORMS
Variola major is severe and most common form of smallpox, with more extensive rash and higher fever.
4 types of Variola major smallpox:
ordinary (90% or more of cases);
modified (mild and occurring in previously vaccinated persons)
flat and hemorrhagic (rare but with high mortality)
Variola minor is less common presentation of smallpox, and much less severe disease, with death rates historically of 1% or less.

4. SMALLPOX HISTORY
Blankets infected with smallpox were given to Indians by British solders during French and Indian war in North America.
Smallpox (Variola major) declared eradicated by World Health Organization (WHO) in 1979.
Last case reported in US in 1949 and world-wide in Somalia 1978.

5. TRANSMISSION
Direct and fairly prolonged face-to-face contact required to spread from one person to another.
Smallpox also can be spread through direct contact with infected bodily fluids or contaminated objects such as bedding or clothing.
Rarely, smallpox has been spread by virus carried in air in enclosed settings such as buildings, buses, and trains.
Humans are only natural hosts of Variola. Smallpox is not known to be transmitted by insects or animals.

6. TRANSMISSION
Bio-terror attack using weaponized smallpox could occur by inhalation of airborne virus, especially in Variola susceptible (unvaccinated) population.
Person with smallpox is sometimes contagious with onset of fever (prodrome phase).
But person becomes most contagious with onset of rash.
Infected person is usually very sick and not able to move around in community. Infected person is contagious until last smallpox scab falls off.

7. CLINICAL MANIFESTATIONS
7-17 days after respiratory exposure.
Febrile prodrome (2-3 days) with headache, back ache and vomiting
15% of patients develop delirium.
In hours - rash appears on face, upper extremities and oral mucosa.
Palms and soles of feet are commonly involved.

8. CLINICAL MANIFESTATIONS
Rash spreads centrally to legs and trunk during second week.
Mortality in unvaccinated is 30%.
Lesions are synchronous and start as macules progressing to papules and then to pustules.
Scabbing develops 7-14 days from onset of rash, leaving behind hypo pigmented depressed scars.

9. CLINICAL MANIFESTATIONS

10. TREATMENT Treatment is supportive.
No existing antiviral drugs have proven clinical efficacy.
Vaccination of exposed persons within 3-5 days has been shown to be effective in decreasing or preventing development of smallpox.

11. WHAT IS CURRENT THREAT?
Twenty tons of liquid smallpox kept on hand at Soviet military bases.
Bio-warheads on Soviet ICBM missiles were test launched in the Pacific Ocean from
Warheads unusually heavy and spinning wildly: thought to have had active refrigeration system to keep temperature near or below boiling temperature of water during re-entry.
References: Ken Alibek, Biohazard, Dubbleday books, 1999
Richard Preston, “The Demon in the Freezer”, New Yorker, July 12,1999

12. WHAT IS CURRENT THREAT?
VECTOR pursued active weaponized smallpox research into 1990’s.
CIA has serious concerns about clandestine stocks:
Russia, China, India, Pakistan, Israel, Korea, Cuba, Serbia; links to Al Queda, Aum Shinriko
UNSCOM Iraqi inspections noted concerns with buildings that confirmed work with camel pox had been done on site.

13. CURRENT STATUS OF U.S. POPULATION IMMUNITY TO SMALLPOX
Routine vaccination ceased in U.S. in 1972
Previously vaccinated individuals confer 3-5 years.
After 5 years - level of protection is unknown.

14. IMPLICATIONS OF SMALLPOX RELEASE
A single person anywhere in world would be considered global medical emergency.
Crude mortality rate 30%.
Outbreak response would require immediate, mass vaccination (post-event) campaign.
Vaccination within 3-5 days of exposure to smallpox can prevent disease or at least decrease symptoms.

15. WHAT IS SMALLPOX VACCINE?
Dryvax(Wyeth-Ayherst) - made from NYCBOH strain of live virus from stock used 30 years ago.
Vaccine made from virus called vaccinia - “pox” type virus related to smallpox, but milder.
Prepared from infected calf skins infected with vaccinia; material scraped from lesions, freeze dried and added to antibiotics.
Dryvax is mixed 1:1 with diluents. 1 vial contains enough vaccine to vaccinate 100 persons
1:5 dilution not approved by FDA but will be used if outbreak occurs.
Vaccine contains “live” Vaccinia virus, not dead virus like many other vaccines, and does not contain smallpox virus.

16. The Smallpox Vaccine U.S. vaccine (Dryvax): 15.5 million doses
– 1.7 million doses licensed
– 1 million of doses for military
Aventis Pasteur: million doses
– reserve
Acambis/Baxter: 286 million doses
– will not be licensed until late 2003, early 2004

17. The Smallpox Vaccine
Smallpox vaccination provides high-level of immunity.
Previously vaccinated individuals likely will have faster “take” and less chance of serious side effects.
If person is vaccinated again later, immunity lasts longer.
Historically, vaccine effective in preventing smallpox infection in 95% of those vaccinated. (Based on data from 60’s)

18. Who should get Vaccine?
On December 13, 2002 President Bush announced a plan to protect the American people against the threat of smallpox attack by hostile groups or governments.

19. Who should get Vaccine?
Department of Health and Human Services (HHS) will work with state and local governments to form volunteer Smallpox Response Teams
Teams will provide critical services to their fellow Americans in event of smallpox attack.

20. Who should get Vaccine?
Military and Department of Defense personnel now receiving vaccine (as of 12/13/02).
Persons involved in administration of vaccine.
Health department vaccination teams
Persons who may come in contact with person who has smallpox.
Individuals who wish to receive vaccine on voluntary basis absent outbreak of smallpox.

21. Who should get Vaccine
DECISION TO RECEIVE SMALLPOX VACCINE IS A PERSONAL ONE.
GOAL OF THIS PRESENTATION IS TO GIVE MOST UP TO DATE INFORMATION TO ASSIST INDIVIDUALS IN MAKING AN INFORMED DECISION.

22. Who should NOT get Vaccine?
Individuals who have any of the following conditions, or live with someone who does, unless they have been exposed to the smallpox virus:

23. Who should NOT get Vaccine?
Persons with eczema or atopic dermatitis & other acute, chronic or exfoliative skin conditions.
Persons diagnosed with previously mentioned skin conditions even if condition is not active.
At high risk of developing eczema vaccinatium.
Eczema vaccinatium is potentially severe & sometimes fatal complication.

24. Reaction after Vaccination
Eczema vaccinatum.
Serious skin rashes caused by widespread skin infection in people with conditions such as eczema or atopic dermatitis.

25. Who should NOT get Vaccine?
Skin conditions such as burns, chickenpox, shingles, impetigo, herpes, severe acne, or psoriasis.
If potential vaccinee or any of their household contacts have previously mentioned skin conditions, they are at high risk for inadvertent autoinoculation of affected skin with vaccinia virus and should not be vaccinated until skin condition resolves.

26. Who should NOT get Vaccine?
Weakened immune system, cancer treatment, organ transplant, HIV, or medications to treat autoimmune disorders and other illnesses that can weaken immune system.
If potential vaccinee or any of their household contacts have previously mentioned conditions they should not be vaccinated.
At a higher risk of developing a serious adverse reaction resulting from unchecked replication of vaccinia virus (progressive vaccinia).

27. Who should NOT get Vaccine?
HIV testing should be readily available to all persons considering smallpox vaccination.
Confidential testing is recommended for those with any history of HIV risk factors. Persons with positive test result should be told not to be present at vaccination site.

28. Who should NOT get Vaccine?
Pregnancy
All vaccines that contain live viruses are contraindicated during pregnancy.
People should be asked if they or anyone in their household is pregnant or plans to become pregnant over 4 weeks following vaccination.
Routine pregnancy testing for women of child bearing age is not recommended.
Breast-feeding.

29. Who should NOT get Vaccine?
Under age of 12 months.
Or if there is a child in the home who is less than 1 year old.
Currently ill
As with any vaccine, vaccination should be given in currently healthy individuals.

30. How Vaccine Is Given
Scarification using bifurcated (two pronged) needle dipped into reconstituted vaccine solution.
Vaccine placed on clean area of skin. Alcohol not used to prep skin.
15 rapid jabs to skin in circular fashion with bifurcated needle to deliver vaccine to dermis.

31. Smallpox Vaccine Administration
Invented by Dr. Benjamin A. Rubin of Wyeth Laboratories, patented in July Developed in conjunction with Reading Textile Machine Company. Bifurcation holds exactly 1 mg of water, slightly more vaccine because of increased viscosity. WHO procured about 50 million bifurcated needles between 1967 and The 1970 price was about US$5 per 1000.

32. “TAKE REACTION”
1st week - bump becomes large blister, fills with pus, and begins to drain.
2nd week - blister begins to dry up & scar. Previously vaccinated people have faster progression of scabbing.

33. Post Vaccination Care
After vaccination, it is important to follow care instructions for site of vaccine.
Because virus is live, it can spread to other parts of body, or to other people.
Autoinoculation occurs in about 1 per 1,900

34. CARE OF VACCINATION SITE
Cover site with dry dressing and hold in place with semi-permeable bandage which should be changed every other day.
Proper hand washing and proper disposal of contaminated bandage material prevents auto inoculation of unintended persons.
Bandage material carries live virus.

35. CARE OF VACCINATION SITE
Long sleeve shirts recommended to avoid inadvertent scratching which would transfer virus to other parts of body or other persons.
Proper washing and disposal procedures should be followed until scab falls off.
days

36. Expected Reaction After Vaccination
Mild to moderate / self limiting side effects
Arm receiving vaccination may be sore and red where vaccine was given.
Mild rash, lasting 2-4 days.
Regional lymphatic swelling 2-4 weeks.
Generalized weakness, “feel ill” in 20-30%, beginning on day 7-8.
May feel bad enough to miss work, school, or recreational activity or have trouble sleeping.
Fever >100, 17%, >102 in 3% of vaccinated persons.

37. Moderate To Severe Reaction After Vaccination
Moderate to severe side effects
Generalized vaccinia - rash over entire body (1 in 4,000)
Eczema Vaccinatium - severe rash, occurs independent of current status of eczema condition. (1in 26,000?)
Post-vaccine Encephalitis allergic or autoimmune participant - 15 –25% of patients will die. 25% will have permanent neurological symptoms. (1 in 83,000?)

38. Moderate To Severe Reaction After Vaccination
Vaccinia Necrosum/Progressive Vaccinia - non-healing site due to cellular-immunodeficiency, may be as many as (1in 667,000 ?)
Autoinoculation occurs in about 1 per 1,900
Death
Primary vaccinees: 1 per 2 million vaccinated
Re-vaccinees: 1 per 4 million
Most complete nationwide smallpox safety data (1968) reported by Breman J and Henderson, DA in New England Journal of Medicine April Dan Hanfling, MD FACEP December 13, 2002

39. Reaction after Vaccination
A vaccinia rash or outbreak of sore limited to one area.
This is accidental spreading of vaccinia virus caused by touching vaccination site and then touching another part of body or person.

40. Reaction after Vaccination
Vaccinia Necrosum/ Progressive Vaccinia (non-healing site due to cellular-immunodeficiency) may be as many as 1 in 667,000
Frequently leading to death.

41. Unanswered Questions for Risk Managers
Should vaccinated staff be “furloughed” to reduce potential for auto inoculation?
Not recommended by Advisory Committee for Immunization Practices (ACIP)
How should pre-screening be done and how far in advance of receiving vaccine?
What are liability issues for auto inoculation to family member,employee or patient?
How will “take” monitoring be accomplished if an employee is off?

42. Initial Policy Issues
How will we manage “pre-vaccination” distribution of educational information / training to employees and their families?
How will we conduct medical “pre-screening” for presence of contraindications to vaccine?
Will we provide any diagnostic testing for employees who may be unsure of their risk status? (i.e., pregnancy, HIV)

43. Initial Policy Issues
How will employee who is vaccinated as part of their reserve military service be treated ?
How will vaccination reactions be treated under workman’s compensation policies?

44. Initial Policy Issues
How will employee’s family members be treated under our vaccination plan?
How will we conduct follow-up “take” examinations that are required to ensure that vaccine was properly administered?

45. Initial Policy Issues
To what extent will we provide employees and their families with medical supplies for required after care?
How will we train employees and their families in caring for injection site and required safeguards associated with this “high risk” activity? (PPE, biohazard waste)

46. Initial Policy Issues
Non-emergency work requirements that may complicate vaccine site care and cleanliness must be modified / suspended.
How will we manage this requirement?
Fire, EMS and Police activities place vaccination site at risk for injury.
What work modifications can be made to provide additional safeguards?

47. Initial Policy Issues
What temporary workplace requirements, policies, procedures must be enacted to safeguard others?
bed linens, blankets, laundering clothes, hand washing, etc.
What waiver(s) will an employee who refuses vaccine be required to execute to document that they rejected employer’s offer for inoculation?

48. Initial Policy Issues
What will our policy be for handling employee who refused voluntary vaccination, but is exposed to / or contracts smallpox?
Will exposed “un-vaccinated” employee require “quarantine” until vaccinated post-exposure and medically released?
What are our policies regarding this employee?
How will required medical and training records associated with vaccination program be managed?

49. Initial Policy Issues
Will current health care providers cover any insurance claims with inoculation process?
Are there any pre-existing medical conditions that would negate coverage for family members who may be auto inoculated?

50. International association of Firefighters http://www.iaff.org
For More Information
CDC Smallpox website
International association of Firefighters
National Immunization Program website

51. References Medscape www.medscape.com December 24, 2002
Dr. Dan Hanfling, MD, FACEP Director, INOVA Health System Emergency Management and Disaster Medicine. Presentation to the NOVA Hospital Coalition December 13, 2002
Center for Disease Control web site
Virginia Department of Health
Prepared by George Brown and John Barbachano
City of Fairfax Fire Department
12/30/02