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