1. Smallpox:
Risks of Vaccination
Patricia Lee MD

2. Smallpox Vaccine Does Not Contain Smallpox
Live virus – Vaccinia - pox type virus
Vaccinia - mutated cowpox or variola virus
Unsure when switch came from cowpox to vaccinia
Can be transmitted to other parts of the body or other people
Other live virus vaccines: measles, mumps, rubella, chickenpox

3. Calf-lymph vaccine Dryvax
contains polymyxin B, neomycin sulfate, streptomycin sulfate, chlorotetracycline hydrochloride
Vero monkey kidney cell vaccine, human fibroblast cell vaccine- expected 2004

4. Smallpox Vaccine
15 million doses available to US, plan to purchase 300 million more doses
Dilution seems effective with less side effects
Vaccinate up to 3 days post-exposure
Up to 4-7 days post-exposure may offer some protection or modify severity of disease

5. Vaccination and Immunity
First time vaccination: (45% population)
immunity lasts 3-5 yrs
Revaccination:
longer immunity- 10 yrs
A successful vaccination: “take”
If unsuccessful, revaccinate 7-10 days later

7. Vaccinia Another pox type virus related to smallpox
Vaccine does not contain smallpox virus
cannot spread smallpox
Vaccinia can be spread through the vaccination site – touching site or bandage
Meticulous vaccination site care
It is not airborne

8. Vaccination Given in upper arm
Bifurcated needle dipped in vaccine solution.
Skin is pricked 15 times in a few seconds. Small amount of bleeding
3-4 days: red itchy bump
Week 1: large blister fills with pus, drains
Week 2 : blister begins to dry up and form scab
Week 3: Scab falls off, scar remains
First timers: stronger take
Diluted vaccine is effective

12. Who should NOT receive smallpox vaccine?
Up to 25% of population will be ineligible
Any person who has one of the following conditions OR lives with someone who does
Skin conditions:
Eczema or atopic dermatitis – even if not active
Other skin conditions – burns, chickenpox, shingles, impetigo, herpes, severe acne, psoriasis
Immunocompromised, eg. CA, steroid use, HIV
Pregnancy or plans to become pregnant within one month of vaccination

13. Who should NOT receive smallpox vaccine?
In addition, you should not get the vaccine if:
Less than 18 yrs old
Have small children < 1 yr old
Moderate or short term illness
Breastfeeding
Allergic to vaccine or any of its ingredients
Polymyxin B sulfate, Streptomycin sulfate, Neomycin sulfate
Chlorotetracycline hydrochloride
Inflammatory eye disease
EXCEPTION: If exposed to smallpox – you should get vaccine regardless of health status

14. Reactions to Smallpox Vaccination
Normal, typically mild reactions
Do not require treatment
Arm sore with intense erythema surrounding site
Tender impressive axillary adenopathy
Low grade fever 101, myalgias, malaise
1 of 3 people may miss work, school, recreational activity, or have insomnia around day 4-7
Bacterial infections of site - children

15. Reactions to Smallpox Vaccination
Serious Reactions
1000 people/million vaccinated
Autoinoculation: common
Vaccinia rash limited to one area
Wash hands with soap and water after touching site
Generalized vaccinia - widespread vaccinia rash –due to viremia
Erythyma multiforme, other non vesicular rash
Vaccinia keratitis

16. Reactions to Smallpox Vaccination
Life Threatening Reactions**
14-52 people/million vaccinated for 1st time (300,000)
Eczema vaccinatum – due to autoinoculation or contact with vaccinee
Progressive vaccinia (vaccinia necrosum) – seen in immunocompromised
Postvaccinal encephalitis
**based on studies in 1968

17. Reactions to Smallpox Vaccination
1-3 people/million vaccinated may die (30)
Serious reactions are lower for revaccination – 0.1 deaths/million
USA adverse events rate unknown:
higher due to number of immunocompromised (CA, Tx, HIV, eczema, etc.) or lower due to improved health care???

20. Satellite lesions

21. Satellite lesions

22. Revaccination

23. Revaccination

32. Vaccinia keratitis

36. Progressive vaccinia

45. Erythyma multiforme

46. Erythyma multiforme and revaccination

47. Post vaccination comments
December 5, 2002 Washington Post
200 healthy university students inoculated
1/3 missed at least 1 day of work or school
“The reactions we saw were quite remarkable”
“I just wanted to go to bed for a day or two”
“I thought, can you just chop off my arm?”
“You can’t scratch it, it’s all bandaged up; all I could do was smack it”
“I was pretty miserable for 1 week”
“Range of reactions from small rash to swelling the size of a grapefruit”
“You are going to have to be prepared to see these individuals and to see really bad takes…you’ll wonder if they are bacterial infections; in some cases the rash will move up the arm and onto the chest. The vaccinee requires a lot of TLC”

48. Vaccine Safety Best protection available against smallpox
Most people experience mild reaction
Treatment against serious reactions
Vaccinia Immune Globulin (VIG) 700 doses
CDC controlled
Enough if 6 million vaccinated
Cidofovir 3500 doses
enough if 15 million vaccinated

49. What are we waiting for?
Section 304 Homeland Security Bill covering liability of vaccinations, 1/24/03
Tommy Thompson, Sec HHS will declare immunization program to start
Illinois to finalized issues of workman’s compensation
Chicago
21 hospitals have replied with smallpox response plans
7 hospitals have declined to participate
Others await corporate decisions regarding employee post vaccination care

50. Smallpox Response Team
CDC rollout vaccination plan for smallpox response team in hospitals
50 health care workers/hospital
Expected 30 day completion
Revaccinate 7-10 days after

51. Top 15 Things I Learned About Smallpox Vaccination
Vaccination is preventative
Vaccinia virus is used for vaccine
Previously vaccinated are not immune
Can vaccinate up to 3 days post exposure
Vaccination site must be covered with occlusive dressing and inspected before work duty

52. Top 15 Things I Learned About Smallpox Vaccination
Ineligible for vaccination: either have or live with someone who has:
Pregnancy
Extensive skin disease
Immunodeficiency
Inflammatory eye disease
Eczema (past present or “healed”)
Vaccine component allergy
Child < 1 year old

53. Top 15 Things I Learned About Smallpox Vaccination
1 of 3 persons mild reactions: may miss school or work 5-7 days post-vaccination
1000 persons/million serious reactions
14-52 persons/million with life-threatening reactions
1-3 persons/million will die
VIG and/or Cidofovir for serious reactions

54. Top 15 Things I Learned About Smallpox Vaccination
Previously vaccinated have a lower risk of vaccine complications
Vaccine cannot spread smallpox
Patients who have been vaccinated will come to the ED and require a lot of TLC
If smallpox exposed: all contraindications are null – Everyone should be vaccinated