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National Smallpox Vaccination Program Update
Raymond A. Strikas, M.D.
National Immunization Program
Centers for Disease Control and Prevention
June 3, 2003
Overview
• Preparedness
• Evaluation
• Compensation
• Progress to Date– Vaccination– Adverse events’ summary
• Challenges
• Next Steps
Preparedness
• Smallpox program activities included in FY03 BT Guidance
Provide voluntary vaccination, follow-up service and training to those individuals who would be called upon to control and contain a smallpox outbreak System to manage vaccination adverse events Assessment of legal authorities Identify and train personnel Maintain a database of staff needed to contain an outbreak
Preparedness(continued)
• Smallpox program activities included in FY03 BT Guidance
– Establish/improve rash illness surveillance and laboratory analysis to rapidly detect and investigate a smallpox outbreak
• Improve rash illness reporting• Develop, exercise smallpox response plan• Develop laboratory capacity
– Assure public health has capacity to rapidly protect the public through large-scale vaccination
• Plan to store, manage vaccine• Identify and train staff• Develop, exercise large-scale vaccination plan• Develop communication materials
PreparednessTargets for Vaccination
• Stage 1 – Individuals to remain targets for vaccination and training– Healthcare teams– Public health teams
• Numbers of individuals, teams to be determined by state, local health agencies and hospitals based on locally established preparedness goals
PreparednessTargets for Vaccination
• Stage 2 – Upon completion of Stage 1, others may be targets for vaccination, because they may support smallpox outbreak control efforts
– Security staff to maintain public order– EMS staff, may include fire service personnel performing EMS
duties– Hospital staff at occupational risk– Private health care providers, staff at occupational risk
• Numbers of individuals, teams to be determined by state, local health agencies and hospitals based on locally established preparedness goals
Preparedness(continued)
• Natural pause occurring between stages 1 and 2, as continuation guidance for CDC bioterrorism cooperative agreement implemented:
– May 2 – July 1, 2003: Work plans developed– July 1 – Aug. 1, 2003: Work plans reviewed– Funds awarded by Aug. 30, 2003– Funds support budget period Aug. 31, 2003 to Aug.
30, 2004
Compensation
• May 2003: Law in place that provides benefits to – public health team members– health care team members – public safety personnel
Participating in a smallpox emergency response plan, who are injured as a result of vaccination
Progress to Date
557
62
PROGRAM SUMMARYas of COB Friday, May 23, 2003
Grantees Vaccinating as of 5/23/03Grantees with NO DATA
TOTAL GRANTEES
Number of Grantees Participatingby Program Component
0
10
20
30
40
50
60
Week Ending
No
. o
f G
ran
tees
Rec. Vaccine Vaccinating
1,023 4,213 7,354 12,690 16,919 21,587 25,645 29,584 31,297 32,644 33,444 34,541 35,903 36,217 36,662
# of Individuals Vaccinated,COB 3/14/03
# of Individuals Vaccinated,COB 3/28/03
# of Individuals Vaccinated,COB 5/2/03
# of Individuals Vaccinated,COB 4/25/03
# of Individuals Vaccinated,COB 4/4/03
# of Individuals Vaccinated,COB 4/11/03
# of Individuals Vaccinated,COB 3/21/03
# of Individuals Vaccinated,COB 5/9/03
# of Individuals Vaccinated,COB 5/16/03
SWPR HISTORICAL TOTALS
# of Individuals Vaccinated,COB 4/18/03
# of Individuals Vaccinated, COB 2/7/03
# of Individuals Vaccinated, COB 2/14/03
# of Individuals Vaccinated, COB 2/21/03
# of Individuals Vaccinated, COB 2/28/03
# of Individuals Vaccinated,COB 3/7/03
SNS
289,900 36,959 11,579 23,677 1,703 2,064
# of Individuals Vaccinated Healthcare
Team
# of Individuals Vaccinated
Other
# of Hospitals
with Vaccination
Started
SMALLPOX WEEKLY PROGRESS REPORT (SWPR)
# of Vaccine Doses
Released, 5/23/03
# of Individuals Vaccinated,COB 5/23/03
TOTAL
# of Individuals Vaccinated PH Team
DATA SUMMARYas of COB Friday, May 23, 2003
Cumulative Count of Vaccinations (as reported by grantees)
0
5000
10000
15000
20000
25000
30000
35000
40000
Week Ending
No
. o
f V
ac
cin
ati
on
s
SWPR
Smallpox Weekly Progress Report (SWPR)Weekly Count of Vaccinations
0
1000
2000
3000
4000
5000
6000
Week Ending
No
. o
f V
acci
nee
s
SWPR
2/28: MMWR on Angina
3/14: SARS Outbreak Reported
3/19: Operation Iraqi Freedom Launched
4/4: MMWR on Cardiac Cases & ACIP supplemental exclusion criteria
4/18: Hostilities End
Other Progress (from Plans)
• Plans approved for all states, D.C., NYC, Chicago, Los Angeles, Puerto Rico, and Palau
– Public health teams:• 1,154 teams• 23,265 people
– Healthcare teams:• 4,744 teams• 419,084 people
Adverse Events following Smallpox Vaccination in Civilians
• Outline
– Adverse Event (AE) Overview– Cardiac Adverse Events
AE OverviewVAERS Summary Data, 1/24 – 5/09
• 577 civilian reports
• 574 report only smallpox vaccine
• 57% revaccinees
• 77% female
• 61% from persons aged 40-59 years
• 88% non-serious
AE Overview VAERS and CDC Clinical Team 1/24 – 5/09
In civilian program, no reports of:Eczema vaccinatumErythema multiforme majorFetal vacciniaPost vaccinial encephalitis or encephalomyelitis(1 suspected, see MMWR 5/23/03)Progressive vacciniaPyogenic infection of vaccination siteVaccinia transmission to contacts
AE Overview VAERS/CDC Clinical Team, 1/24-5/09
Adverse Event Number of reports
Number confirmed
Generalized vaccinia 2 1
Inadvertent inoculation, non-ocular
13 4
Ocular vaccinia* 3 2
*VIG released for one ocular vaccinia case
AE OverviewDiagnoses for the Other Serious AEs, 1/24 –
5/09• Angina • Anoxic encephalopathy• Appendicitis• Atrial fibrillation• Atypical chest pain• Cholecystitis• Facial paralysis• Headache• Herpes Zoster • Hypertension• Myocardial infarction
• Neuropathy• Non-cardiac chest pain• Pancreatic cancer• Persistent fatigue• Pneumonia• Premature Ventricular
Contractions• Sinusitis• Transient global amnesia• Urinary tract infection• Vertigo• Vomiting and diarrhea
Cardiac Adverse Events following Smallpox Vaccination
• Myopericarditis had been previously reported before 2003– Mostly from Europe / Australia – More virulent vaccine strain used- No clear association with NYCBOH strain
• Ischemic events not thought to be associated with vaccination
• Myocarditis cases in military led to enhanced surveillance efforts in civilian program
Civilian Vaccinees with Myopericarditis January 24 – May 9, 2003
• 21 cases• Ages 29-61 (median 48)• 15 (71%) females• Onset 1-42 d (median 12) post-vaccination• 19 (90%) revaccinees• All have recovered• Diagnostic tests
– ECG: all abnormal– Echocardiography: 6/18 abnormal– Cardiac enzymes: 1/16 abnormal
Civilian vaccinees with ischemic events, January-May 16, 2003
Age (yrs)
Sex Diagnosis Days
Elapsed
Medical History* Outcome
55 F MI 5 HTN, HL, smoker Died
57 F MI 17 HTN, TIA, smoker Died
54 F MI 10 HTN, DM, HL, FH Survived
64 M MI 2 Exertion dyspnea Survived
46 M MI 0 Angina, HTN, DM Survived
49 M MI 26 None Survived
60 M Angina 4 Angina, HTN, HL Survived
65 M Angina 10 HTN, DM Survived
57 M Angina 24 HTN Survived
*CAD=Coronary Artery Disease; HL=Hyperlipidemia; HTN=Hypertension; DM=Diabetes Mellitus; FH=Family History; TIA =Transient Ishemic Attack
Expected Background Rates of Incident Cardiac Events, April 4, 2003
• Data from:– Atherosclerosis Risk in Communities (ARIC)– CARDIA– Framingham Offspring Cohort- 1971– Age/gender data from vaccinees
• 3 week time frame- post vaccination period
• The actual number of acute myocardial infarction (AMI) events observed was 5.
• The expected number of incident AMI events during 3-weeks of follow-up observation is 2 (95% predictive interval 0.6-5.4)
Data provided by the National Heart, Lung, and Blood Institute and the ARIC,
Framingham Offspring and CARDIA studies.
Cardiac Adverse Events: What CDC is doing
• Rapidly developed new exclusionary criteria for potential vaccinees
• Investigating possible cases• Conducting in-depth case-series of myocarditis
and ischemic patients• Developing case-definitions• Developing evaluation and follow-up guidelines• Evaluating other possible associations: HTN,
dysrhythmias
Cardiac Adverse Events: What CDC is doing
• Completing evaluation of background rates of cardiac events
• Updated Active Surveillance• Updating CISA Smallpox Vaccine Study• Exploring ways to evaluate possible
biologic mechanisms– e.g., potential prospective study might include
measurement of cytokines
New Screening Criteria- 1Pre-event vaccination program
• Persons should not receive smallpox vaccine:– Physician diagnosis of heart disease with or without
symptoms• Known coronary disease including MI/Angina• CHF• Cardiomyopathy• Stroke or TIA• Chest pain or shortness of breath with activity• Other heart conditions under the care of a doctor
New Screening Criteria- 2Pre-event vaccination program
• Persons should not receive smallpox vaccine:– >3 of the following risk factors for coronary artery
disease• Hypertension• Diabetes• Hypercholesteremia• Current smoking• Family history- before age 50
Smallpox Adverse Event ExperienceSummary
• AE data (esp. DoD) suggest that myopericarditis may be causally associated with smallpox vaccination
• Ischemic cardiac events unanticipated; causality uncertain
• No ischemic cardiac events reported among persons vaccinated after new exclusion criteria
• Few AEs historically associated with smallpox vaccine have been reported
• No contact transmission reported in civilian vaccination program
CDC Response Plan Updates• Mass Casualty Guidelines• Enhanced Infection Control Guidelines• Environmental Control (decontamination)• New and Improved! Case reporting and
contact tracing forms • In progress
– Pediatric Issues– Threat Assessment – Incident Command
Challenges
• Threat perception low (post-Iraq conflict)
• Compensation law just passed, not yet implemented
• Assessing opportunity costs
• Integrating smallpox preparedness into overall bioterrorism guidance issued May 2, 2003
• SARS, other competing public health priorities
Next Steps
• Continue evaluation efforts, publish findings
• Provide technical assistance to states in developing coop. agreement workplans
• Develop options for program for general public who insist on vaccination
• Improve PVS
• Determine program reporting requirments