the department of defense smallpox vaccination program

The Department of Defense Smallpox Vaccination

Program

UNCLASSIFIED

Military Vaccine Agency

LTC Stephen FordDeputy Director, Scientific Affairs

17 May 2007

DoD Smallpox Vaccination Program

UNCLASSIFIED

www.smallpox.mil www.vaccines.mil/smallpox

DoD Smallpox Vaccination Program

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Background

• December 2002 President directs smallpox immunization

• December 16, 2002 the Department of Defense (DoD) initiates vaccination of select US forces, emergency essential civilians and contractors deployed in support of US Central Command missions

• To date over 110,000 medical exemptions for contraindications in over 1.2 million Service members vaccinated

DoD Smallpox Vaccination Program

UNCLASSIFIED

Program Principles:

• Multi-media Education: leaders, healthcare workers, and vaccinees• Screening: standardized form to identify ACIP-recognized contraindications• Adverse event monitoring: multiple communication channels, standard case definitions, pregnancy registry, long-term follow-up• Quality standards for immunization: before, during, and after vaccination

DoD Smallpox Vaccination Program

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Education: Smallpox Trifold

Augmented with PowerPointslides and other trainingaids/materials

DoD Smallpox Vaccination Program

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Education: Household Contacts

DoD Smallpox Vaccination Program

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Screening: Medical Note for Contraindications

DoD Smallpox Vaccination Program

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Monitoring:

SmallpoxVaccinePregnancyRegistry

DoD Smallpox Vaccination Program

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Joint regulation (Immunizations and Chemoprophylaxis) requires reporting of adverse events resulting in:

– hospitalization– a life-threatening event (for example anaphylaxis)– time lost from duty more than 24 hours (more than 1 duty

shift)– any event related to suspected contamination of a vaccine

vial– any event warranting a permanent medical exemption (a

contraindicating event)

Monitoring: Reportable Events

DoD Smallpox Vaccination Program

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• Screened: over 1.3M Vaccinated: over 1.2M• Exemption process working well

– Eczema vaccinatum - 1 Progressive vaccinia – 0

• VIG treatments more rare than expected • Education working well

– Autoinoculation - 86– Contact transfer vaccinia - 61: “Don’t let guard down at home.”

• Case evaluation of serious adverse events:– Encephalitis – 4

– Myo-pericarditis -140• Most vaccinia-associated myopericarditis patients experience complete

resolution of MP symptoms and objective findings by 6 months

– Deaths in the peri-vaccination period- 3

Monitoring: Adverse Events as of 9 May 2007

DoD Smallpox Vaccination Program

UNCLASSIFIED

• Screened: over 1.3M Vaccinated: over 1.2M• Exemption process working well

– Eczema vaccinatum - 1 Progressive vaccinia – 0

• VIG treatments more rare than expected • Education working well

– Autoinoculation - 86– Contact transfer vaccinia - 61: “Don’t let guard down at home.”

• Case evaluation of serious adverse events:– Encephalitis – 4

– Myopericarditis -140• Most vaccinia-associated myopericarditis patients experience complete

resolution of MP symptoms and objective findings by 6 months

– Deaths in the post-multiple vaccination period- 2

Monitoring: Adverse Events as of 9 May 2007

DoD Smallpox Vaccination Program

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Monitoring: Case Definitions (MMWR 2003;52:492-6)

DoD Smallpox Vaccination Program

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• Defense Medical Surveillance System (DMSS): – large linked database analogous to Vaccine Safety

Datalink project– Includes demographic, occupational, medical encounters,

immunization registry, and serial serum specimens

• Lack of an association of ischemia or chest pain after smallpox vaccination (manuscript under review)

• Electronic medical record Armed Forces Health Longitudinal Technology Application (AHLTA) being phased-in

Monitoring: DoD Cohort Studies Contrasting Vaccinated and Unvaccinated Personnel

DoD Smallpox Vaccination Program

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• DoD sharing experience with CDC, IOM, and State Health Departments (Dec ’02 to present)

• First case definitions for generalized vaccinia and myocarditis

• Participation on multiple working groups with CDC, ACIP, and the Defense Health Board (formerly the AFEB)

• Scientific publications, such as:– Arness et al. Myopericarditis following smallpox vaccination. Am J.

Epidemiol 2004;160:642-51– Eckert et al. Incidence and follow-up of inflammatory cardiac complications

following smallpox vaccination J Am Coll Cardiol 2004;44:201-5– Barkdoll. Secondary and tertiary transfer of vaccinia virus among US

personnel-United States and worldwide, 2002-2004. MMWR 2004;53:103-5. – Sejvar et al. Neurologic adverse events associated with smallpox

vaccination in the US, 2002-2004. JAMA 2005;294:2744-50.

Monitoring: DoD Commitment to Scientific Communication

DoD Smallpox Vaccination Program

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Vaccine Healthcare Center Network

• Vaccine Clinical Support & Consultation Services

– Adverse events & efficacy case management, exemptions

• Vaccine Safety – Surveillance, reporting & adverse

events registry, long term follow-up

• Immunization Healthcare Education – For Health Care Workers & Service

Members, Beneficiaries, DoD, etc.

• Support for Research– Clinical focus, post-licensure, to

“enhance vaccine safety, efficacy & acceptability”

• Advocacy For– Quality immunization healthcare

delivery– Care of complex AE’s

Outreach & Support 24/7Clinical Call Center (toll-free)Secure Consultative E-mail

Network of MTF-linked Sites NOT service specific but regional

DoD Smallpox Vaccination Program

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Evolving Working Group Document

Based on Case Reviews & Expert Consensus Opinion

Post Vaccine Pericarditis-Myocarditis-Post Vaccine Pericarditis-Myocarditis-Myopericarditis Guidelines: A Work in Myopericarditis Guidelines: A Work in

ProgressProgress

DoD Smallpox Vaccination Program

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Knowledge, Attitudes, And Beliefs (KAB) Regarding the Vaccine Adverse Event Reporting System (VAERS) Among

Department of Defense (DOD) Health Care Workers

• Objectives:

• To assess the knowledge, attitudes and beliefs of military health care providers regarding the identification and reporting of adverse events following immunizations (AEFI)

• Convenience sample of military healthcare workers

• 547 surveys distributed; 512 collected (response rate: 93.6%)

• Overall, ~54% of study respondents were at least somewhat familiar with VAERS before being contacted regarding the survey

• ~48% of all study participants reported having identified a patient with AEFI of any severity at least once

• Of these, less than half (44.9%) reported the last identified AEFI to VAERS

• Preferred method of reporting to VAERS was the VAERS web site (65.1%)

DoD Smallpox Vaccination Program

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Smallpox Vaccination and Myopericardial Injury/Inflammation

• Objectives:• To determine the rate of abnormalities in ECG and/or troponin

elevation and/or other clinical indicators suggestive of symptomatic or asymptomatic myopericarditis within 30 days following influenza or smallpox vaccination

• To assess changes in immune & inflammatory activation markers in a subset of vaccinees who develop indicators of either pericarditis or myocarditis & an age, gender & ethnically matched set of asymptomatic controls.

• Collaborators:• Dr. Christopher Wilson, University of Washington• CDC/CISA/Kaiser

• Enrollment sites: WRAMC, Fort Bragg, University of Washington: Remote civilian cases

• Funding: NIAID, NIH

DoD Smallpox Vaccination Program

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Acknowledgements

• LTC (Dr.) Michael Nelson, Walter Reed Army Medical Center, Department of Allergy and Immunology

• Dr. Limone Collins, Vaccine Healthcare Center Network• CDR (Dr.) Megan Ryan, Naval Health Research Center• COL (Dr.) Renata Engler, Vaccine Healthcare Center• COL Randall Anderson, Military Vaccine Agency• COL (Ret.) John Grabenstein

DoD Smallpox Vaccination Program

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Back-up slides

DoD Smallpox Vaccination Program

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Vaccinia Associated Myopericarditis Outcomes

• Symptoms– Criteria

• Any symptom in CDC case definition• Any other new persistent symptom (n=0)• Other new symptom affecting QOL of life

attributable to vaccine by HCP (n=0)– CP & fatigue most frequent– Late CP usually transient & atypical for

ischemia or MP• recurrence of typical VAMP CP in 1-2

– Nonsystematic

• Objective findings– No persistence of clinically

relevant findings– Nonspecific ECG changes (normal

variants)– Multiple interpreters– Nonsystematic

0%

20%

40%

60%

80%

100%

Acute(n=123)

1-6 mos(n=72)

6-18 mos(n=54)

> 18 mos(n=21)

Any symptom

Chest pain

Fatigue

Dyspnea

Myalgia

Headache

Fever

0%

20%

40%

60%

80%

100%

Acute(n=123)

1-6 mos(n=72)

6-18 mos(n=54)

> 18 mos(n=21)

ECG

Cardiac Enz.

Stress test

Echo

MRI

DoD Smallpox Vaccination Program

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Vaccinia Associated Myopericarditis OutcomesConclusions

• Most VAMP patients experience complete resolution of MP symptoms and objective findings by 6 months

• Up to ~30% may have nonspecific symptoms (esp. CP & fatigue) &/or ECG findings >6 months after onset of VAMP

• Avoidance of activities that increase cardiovascular risk should be undertaken for at least 6 months by these pts