Hospital Smallpox Vaccination Perspective Dino P. Rumoro, D.O., F.A.C.E.P. Clinical Chairman...

Hospital Smallpox Vaccination Perspective

Dino P. Rumoro, D.O., F.A.C.E.P.

Clinical Chairman

Assistant Professor

Department of Emergency Medicine

January 10, 2003

Center of Excellence:Bioterrorism Preparedness

Supported by a grant from the

Chicago Department of Public Health

©2002 Rush-Presbyterian-St. Luke’s Medical Center

What You Must Be Asking Yourself:

Questions•Why?…Is this important•What?..Is the risk of an outbreak•What?..Is the risk of the vaccine•How?…Do I proceed

•DO I PROCEED?


History of Bioterrorism

6th Century B.C.•Solon of Athens poisoned water with skunk cabbage during the siege of Krissa

184 B.C.•During a naval battle against King Eumenes of Pergamon,

Hannibal hurled pots of snakes

1346•During the siege of Kaffa, the Tartar army catapulted its plague

infected dead over the city walls



15th Century•Pizarro gave South American natives clothing infected with

smallpox

1914-1917•WWI: Germany allegedly tried to spread cholera in Italy and

plague in St. Petersburg

1936•Unit 731 formed - Japanese biowarfare team responsible for

thousands of deaths



1941-1943•US army develops biological agent R&D unit

1960’s•Vietcong use fecally contaminated spear traps

1978•Bulgarian exile, Georgi Markov, dies after assassin injects ricin

pellet from an umbrella

1979•USSR Military Compound 19 explodes and releases an agent

that kills 40-1000 (anthrax)


Who is Manufacturing Bioweapons?

Iran, Iraq, Libya, Syria, North Korea, Taiwan, Israel, Egypt, Vietnam, Laos, Cuba, Bulgaria, India, South Korea, South Africa, China, Russia

(Based on a 1995 Office of Technology Assessment Report)


What Are the Chances…?

History is against us!


Domestic Bioterrorism Attacks

1984•Salmonella Poisoning in Oregon

•Bhagwan Shree Rajneesh of the Rajneeshee religious cult

•750 people infected, 40 hospitalized

•Purpose was to influence a local election


Domestic Bioterrorism Attacks

2001•Anthrax laden letters


Ask Yourself…?

Did you really think there was ever a chance of an anthrax attack?


Smallpox


History of U.S. Smallpox Vaccine Recommendations

1940’s: Last US case of smallpox1971: Discontinued routine vaccination of the

public1976: Discontinued vaccination of healthcare

workers1989: Discontinued vaccination of the military2003: Voluntary vaccination for first responders to

a case of smallpox


History and Significance

•Endemic smallpox was declared eradicated in 1980 by the WHO

•2 WHO approved repositories of Variola virus

•CDC in Atlanta

•Institute for Viral Preparations in Moscow–Extent of clandestine stockpiles in other parts of the world

remains unknown–Japan considered the use of smallpox as a bioweapon in WW II


What is the Current Risk?

Logically, some degree of risk must exist!


Before You Say No, Consider This...

Military Personnel

•Vaccination program has begun•Reservists currently working in hospitals may be

vaccinated soon•How will their patient care activities be monitored?•What if they become ill?•Who will care for a case of Vaccinia?


Knowledge is Power

Know the Facts!


Smallpox Vaccine

Contains live Vaccinia virus•does not contain smallpox virus

Dryvax (Wyeth) vaccine•produced using calf lymph

•vaccine used in the 1960’s

•FDA licensed specific lots in October 2002

•only available from CDC


Bifurcated Needle


Vaccine Administration

Scarification •multiple punctures with a bifurcated needle to inoculate the

superficial layers of the skin with Vaccinia

•virus multiplies and causes the body to produce an immune response to Vaccinia

–immunity to Vaccinia is cross-protective against smallpox


Clinical Response to Vaccination

1. Papule forms (day 3-4)

2. Vesicle forms (day 5-6)–fluid filled blister

3. Pustule forms (day 7-9)–purulent fluid filled blister

4. Scab forms (day 12-17)

5. Scab falls off (day 18-28)

*The site is infectious until the scab falls off


Development of Immunity

•95% of primary vaccinees develop antibodies within 1-2 weeks–protection begins to fade after 5 years

•Those previously vaccinated may have residual immunity, but need to be revaccinated

–does not offer full protection from smallpox

–may be protective against severe disease or death


Clinical Response to Vaccination

•Major reaction – “take”•indicates viral replication has occurred and the vaccination was successful

•considered to be protective

•Equivocal reaction •anything other than a major reaction

•indicates incorrect vaccination technique or impotent vaccine

•requires revaccination

–can be revaccinated 7 days after initial vaccination


Vaccination Complications

•Most benign, even if frightening in appearance•Some serious, but treatable•Few, which are rare, can be life threatening or fatal


Potential Vaccine Side Effects

Symptoms usually occur about 1 week after vaccinationsorenessinflamed red ring around vaccination sitegeneralized weaknessswollen lymph nodes (25-50%)fever > 100 F (2-16%)muscle aches, headache, chills, nausea (0.3 – 37%)fatigue satellite lesions


Accidental Implantation(inadvertent inoculation)

•Transfer of Vaccinia virus to other body parts or unimmunized close contacts

•Common site are mucocutaneous borders (eyes, mouth, nose, rectum)

•Young children at greatest risk•Lesion progression usually follows the same course as the

vaccination site•Treatment usually not necessary


Supportive Therapy

•Today’s medical treatments are improved from the ones available prior to 1971

–cidofovir as IND

•No evidence exists, but these treatments may help to improve the outcomes of smallpox vaccine

complications


Pre-Event ACIP Recommendations

Phase I: Hospital and public health response teams•vaccination for hospital response teams and public health response teams

Phase II: Other first responders - fire/police/EMS

Phase III: General public? Wait for new Acambis vaccine


Pre-Event Vaccination Program

•Not meant to be a full scale response•Meant to be scalable if cases would occur

–quick response and scale up of numbers of vaccinees

•No further CDC guidelines for phase II or III plans•Plans must be flexible


Smallpox Healthcare Teams

•Each hospital identify a group of healthcare workers who would be vaccinated

•First 7-10 days, this team would be hospital based and provide care 24 hrs/day (8-12 hour shifts)

•Would enable care of the first few cases presenting to a hospital

•Would be able to care for the patient immediately thus minimizing further exposures


Order of Vaccination

•First: Public Health Response Team–Will perform all vaccinations

•Second: Hospital Site Care Team–Several member team to monitor the status of the Hospital

Response Team Members and their vaccination sites

•Third: Hospital Response Team


Hospital Response Team:Recommended Members

•Emergency staff•Intensive care staff•General medicine staff•Medical house staff•Medical sub-specialty staff•Infection control•Phlebotomy•Respiratory therapy•Security•X-ray techs•Housekeeping and laundry


Hospital Response Teams

Hospital Response Team makeup:•vaccination of health care staff for purpose of caring for

patients, NOT for protecting all healthcare workers

•vaccinees have a responsibility to provide care if a case occurs

•total hospital vaccinees expected: 50-100/hospital


RPSLMC Hospital Response Team

Physicians•Emergency 6•ID: Adult 3•ID: Peds 1•Critical Care: Adult 6•Critical Care: Peds 1•Psychiatrist 1•Other 7

_______________________

Total 25



Nurses•Emergency 20•Critical Care: Adult 20•Critical Care: Peds 2•Infection Control 3•Other 10

_______________________

Total 55

_______________________

Grand Total 80



Miscellaneous•Site Care Team 5•Respiratory 2•Security 5•HVAC Technician 1•Radiology 2•Housekeeping 4•Mortuary 1

_______________________

Total 20

_______________________

Grand Total 100


Key to a Safe Vaccination Program

•Thorough screening for contraindications to eliminate individuals who are ineligible to

receive the vaccine


Contraindications in a Pre-Event Setting

•Pregnancy or breast feeding•Immunodeficiency

–HIV/AIDS–cancer

•Immunosuppressive therapies–cancer treatment–organ transplant maintenance–long-term steroid therapy

•prednisone: 2 mg/kg/day or 20 mg/day for 14 days or longer



•Eczema / atopic dermatitis–healed or active

•Vaccine component allergy–neomycin–streptomycin–polymyxin–tetracycline

•Eye disease of conjunctiva or cornea–pruritic lesions–florid inflammation



•Extensive skin diseases

(until the condition resolves)–acne–burns–wounds–recent incisions–impetigo–contact dermatitis



Household Contact with Contraindication

•Risk of accidental inoculation of household contacts exists until the scab falls off

–immunocompromised–eczema

•Infants <1 year (under evaluation)•Should defer immunization in pre-event setting

Rush Presbyterian-St. Luke’s Medical CenterSmallpox Response Team

Prescreening Tool

Introduction: President Bush has recently announced the smallpox vaccination plan forthe United States. In the initial phase, members of the military and smallpox responseteams would be vaccinated. The City of Chicago has asked each hospital in the city toprovide plans for a smallpox response team for their hospital. The Rush SmallpoxResponse team would consist of approximately 100 select hospital personnel who wouldbe vaccinated for smallpox and be involved in caring for the first potential cases ofsmallpox seen at Rush. Personnel successfully vaccinated for smallpox are immune fromacquiring smallpox infection.

Instructions: This document is not a consent for smallpox vaccination, rather it is a toolto determine how many of our key employees might be eligible and willing to receivesuch vaccination. Please complete this tool even if you are unwilling or unable to receivevaccination. Your responses are confidential. This is a two-page form.

Please print:

Department: _____________________ Position (MD, RN, RT, Security etc)______________

Do you have clinical experience with (circle one): adults children both

Last Name: _______________________ First Name:_____________________Age:_____

Employee ID Number:_______________ Are you (circle one): full time part time

Work phone:______________pager:__________________Home phone:_________________

Please check the appropriate box:

Have you ever been vaccinated for smallpox? ? yes ? no ?unsure

Are you (or household member) currently pregnant ? yes ? no ?unsure or trying to become pregnant?

Do you have children in your home less then 1 year old? ? yes ? no ?unsure

Do you have eczema, or have you ever had eczema? ? yes ? no ?unsure

Has anyone in your home ever had eczema? ? yes ? no ?unsure

Have you ever had an allergic reaction to smallpox vaccine? ? yes ? no ? unsure

Are you allergic to polymyxin B, streptomycin, ? yes ? no ? unsure Tetracycline, neomycin, or phenol?

Are you immunosuppressed from cancer treatment, ? yes ? no ? unsure organ transplant or other condition? Describe:________________________

Is anyone in your home immunosuppressed from cancer ? yes ? no ? unsure treatment or organ transplant?

Are you currently breastfeeding? ? yes ? no ? unsureDo you believe that you might have any other medical

contraindications for receiving smallpox vaccination? ? yes ? no ? unsureDescribe:______________________________________________

In the coming weeks you will be receiving additional education related to the benefits and risksof smallpox vaccination. Members of the Rush Smallpox Response Team will all be volunteers.Rush will not require any employee to be vaccinated. Rush will provide free screening forHIV, and pregnancy if requested. Employees will not be required to utilize any PTO time toparticipate in this effort.

Based on what you currently know, please complete the following:

? I would like to be considered for participation in the Smallpox Response team, whichincludes vaccination with smallpox.

? I am not interested in being part of a Smallpox Response Team.

If you would like to discuss any components of this form prior to completing it, you maycontact any of the following:

Gordon Trenholme, MD 2-5865Stacy Pur, Infection Control 2-3056Stephanie Black, MD 2-4451John Segreti, MD 2-5865

Please return this form to Stacy Pur, 143 Ac Fac in the envelope provided.


Logistics

Hospital Response Team phase-in•designate a small proportion (20-30%) for first round to gain

experience in post-vaccination management•stagger HCW within an individual unit by ~three weeks


Hospital Responsibilities

•Participating hospitals will need to: •provide pre-program education•identify their hospital response team•evaluation and treatment of adverse events•pre-shift, daily management of vaccination site until scab off

–assess dressings, change dressing as needed–assess site for local reactions and for vaccine take

•evaluation of vaccination ‘takes’ and reporting to public health authorities


Resources

www.bt.cdc.gov/training/smallpoxvaccine/reactions/default.htm

Rush specific information email:

<[email protected]>

Hospital Smallpox Vaccination Perspective Dino P. Rumoro, D.O., F.A.C.E.P. Clinical Chairman...

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