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Immunization Safety System- Registry Linkages: Lessons Learned from the Smallpox Vaccination Program

Immunization Safety System- Registry Linkages: Lessons Learned from the Smallpox Vaccination Program . John Iskander, David Walker, Roseanne English-Bullard, Susanne Pickering, John Copeland, Warren Williams, Robert T. Chen, David King, Vicki Kipreos, Carol Knowles, Susan Reef .

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Immunization Safety System- Registry Linkages: Lessons Learned from the Smallpox Vaccination Program

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  1. Immunization Safety System- Registry Linkages: Lessons Learned from the Smallpox Vaccination Program John Iskander, David Walker, Roseanne English-Bullard, Susanne Pickering, John Copeland, Warren Williams, Robert T. Chen, David King, Vicki Kipreos, Carol Knowles, Susan Reef

  2. Presentation Outline • Registry-safety monitoring linkage: the smallpox vaccination experience • The “Data Mart” approach • Routine integration of registry activities with vaccine safety systems: review of benefits and status of current activities

  3. Background • Smallpox Vaccine (Dryvax) re-licensed in October 2002 • United States Smallpox Vaccination Program announced in December 2002 • State/local health departments commenced vaccinating response teams on 1/24/03 • Because of rare but potentially serious adverse effects, extensive screening and safety monitoring established

  4. Vaccine Adverse Event Reporting System (VAERS) • U.S. spontaneous reporting system for vaccine safety; In existence since 1990; jointly operated by FDA and CDC • The primary objectives of VAERS applicable to smallpox vaccine safety surveillance are to: 1) Detect new, unusual, or rare vaccine adverse events (AE) 2) Monitor for increases in known AE 3) Determine risk factors for particular types of adverse events • Subject to important limitations common to other passive surveillance systems • Underreporting/biased reporting • Inclusion of adverse events (AE) not known to be causally related to immunization

  5. Adverse Event Reports After Infant ( < 1 y.o.) Vaccination,by Vaccine Combinations Received, VAERS 1989-2000

  6. US Smallpox Vaccine Adverse Events: Surveillance system overview

  7. Pre-Event Vaccination System (PVS) • PVS served as a registry for civilians who received smallpox vaccine • The Pre-Event Vaccination Number (PVN) served as the unique identifier for each vaccination that was administered as well as the subsequent “take” reading and active surveillance report • Data was entered into either directly into PVS at the state/local level via secure web portal or indirectly into a state supported system

  8. Electronic Reporting to VAERS Encouraged • Advantages: • Permits entry of patient vaccination number (PVN) for comparison with denominator data • Electronic submissions available as data within as little as 24 hours; paper reports 1-2 weeks • Security of data transmission (128 bit encryption, SSL technology)

  9. Enhancements to VAERS for Smallpox AE Reporting • Both numerator (VAERS) and denominator (PVS) data updated regularly • VAERS data integrated with other safety databases to provide safety surveillance summaries weekly; disseminated via MMWR and CDC website • Aggregate data reports and lists of serious and non-serious reports received by VAERS provided to state/local health departments weekly via CDC Secure Data Network (SDN)

  10. Summary Data, VAERS and PVS: 1/24 – 10/9/03 • 38,655 persons vaccinated (through 10/3) • 814 civilian VAERS reports • 88% non-serious by regulatory criteria (no reported hospitalization, death, life threatening illness, or disabilty) • Event reporting rate 21.1/1,000 vaccinees • >99% report only smallpox vaccine • 76% female • 61% from persons aged 40-59 years

  11. VAERS Evaluation Data, 1/24-10/09 • Proportion of reports: • Submitted electronically: 66.0% • Containing accurate “registry” number (PVN): 64.3% (after active follow-up) • Containing unverifiable PVN: 4.3%

  12. Active Surveillance • As of 6/11/03: • 10,835 records 28 days or more post vaccination; 44% of total in PVS • Specific conditions identified: • Adverse events 3.7%; 39% local reactions • Medical treatment required 2.0% • Contraindications to vaccination: Vaccinees 0.2%, contacts 0.3% • Cardiac risk factors 0.8-9.6%

  13. Lessons Learned • Need for stronger linkages between VAERS, PVS, and active surveillance • Barriers to more complete PVN reporting to VAERS included: • Regulatory • IT/technical • State specific issues related to adverse event reporting policies and procedures

  14. Smallpox Data Mart (SDM) • Copies data from disparate sources to a common repository • PVS • Active Surveillance • VAERS • Smallpox Weekly Progress Report (SWPR) • Performs transformations of “raw” transactional data to provide data that is more “analysis-ready”

  15. SDM Data Transformation • Transactional data not analysis-ready • Duplicate records • Multiple vaccines for single person • Information contained in multiple tables • SDM cleans and transforms data as it is extracted from sources • Transformations can be tailored for frequently-requested analyses • Facilitates consistency among different analysts

  16. SDM Source DataAnd Key Data Linking Fields PVS AS VAERS SWPR PVN Grantee PVN Grantee PVN Grantee Grantee Smallpox Data Mart

  17. Registries and Their Role in Vaccine Safety

  18. National Vaccine Advisory Committee, • Subcommittee on Coverage, 2/97 : • “IR should be developed with the capability of .. monitoring vaccine safety.” • Consumer Reports 8/01: “Policy-makers should continue - and adequately finance - improvements in tracking and analyzing (potential) vaccine injuries. This includes expanding state IR…which are invaluable for researching vaccine safety...” Immunization Registries (IR) & Vaccine Safety Recommendations

  19. Improve reporting to VAERS: • Decrease under-reporting • Increase timeliness • Increase accuracy • + denominators => rates => better (only?) source of potential safety signals • Potential linkage to other population-based registry and datasets • Better care for minority with serious AEs • Alerts to potential contraindications • Advise/enroll in studies on managing AE Immunization Registries and Vaccine Safety: Potential Benefits

  20. VAERS Reporting Pathways:Future Direction Parent VAERS Paper or Phone Web (stand alone) Health Care Provider Registry

  21. Vaccine Safety and Registry Community Working Group(VASREC) • Purpose: To serve as a forum for consensus development, problem solving, and feedback on issues, topics, concerns relating to closer integration of vaccine safety information into immunization registries. Specifically, electronic reporting to VAERS that originates from registries.

  22. Products • The group will strive to produce documents that describe a consensus perspective on the specific issue being addressed. Many of the issues will be functional descriptions and descriptions of options.

  23. Leadership of the VASREC Group • Chair: Warren Williams, MPH • Meeting time: 3rd Friday of the Month • Email: wxw4@cdc.gov • Virtual meetings via phone call, email • CDC/AIRA (American Immunization Registry Association) representation by both registry and vaccine safety program staff • All interested parties welcome to participate on an ongoing basis

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