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

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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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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

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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

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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

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Adverse Event Reports After Infant ( lt 1 y.o.)
Vaccination,by Vaccine Combinations Received,
VAERS 1989-2000
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US Smallpox Vaccine Adverse Events
Surveillance system overview
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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

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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)

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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)

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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
• gt99 report only smallpox vaccine
• 76 female
• 61 from persons aged 40-59 years

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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

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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

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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

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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

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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

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SDM Source DataAnd Key Data Linking Fields
PVS
AS
VAERS
SWPR
PVN Grantee
PVN Grantee
PVN Grantee
Grantee
Smallpox Data Mart
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Registries and Their Role in Vaccine Safety
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• Immunization Registries (IR) Vaccine Safety
  Recommendations

• 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 IRwhich are invaluable for
  researching vaccine safety...

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• Immunization Registries and Vaccine Safety
  Potential Benefits

• Improve reporting to VAERS
• Decrease under-reporting
• Increase timeliness
• Increase accuracy
• denominators gt rates gt 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

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VAERS Reporting PathwaysFuture Direction
VAERS
Parent
Paper or Phone
Web (stand alone)
Health Care Provider
Registry
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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.

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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.

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Leadership of the VASREC Group

• Chair Warren Williams, MPH
• Meeting time 3rd Friday of the Month
• Email wxw4_at_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