National Smallpox Vaccination Update Joseph M. Henderson Centers for Disease Control and Prevention.
National Smallpox Vaccination Program Update Raymond A. Strikas, M.D. National Immunization Program...
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Transcript of National Smallpox Vaccination Program Update Raymond A. Strikas, M.D. National Immunization Program...
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