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VACCINE SAFETY: 101. Pandemic Influenza Vaccine Safety Conference Atlanta, Georgia August 21, 2008. VACCINE SAFETY:OVERVIEW. IMPORTANCE OF VACCINE SAFETY IN A PANDEMIC CLINICIAN’S ROLE IN VACCINE SAFETY VACCINE SAFETY SURVEILLANCE RISK COMMUNICATION QUESTIONS & ANSWERS.

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vaccine safety 101
VACCINE SAFETY: 101

Pandemic Influenza Vaccine Safety Conference

Atlanta, Georgia

August 21, 2008

vaccine safety overview
VACCINE SAFETY:OVERVIEW
  • IMPORTANCE OF VACCINE SAFETY IN A PANDEMIC
  • CLINICIAN’S ROLE IN VACCINE SAFETY
  • VACCINE SAFETY SURVEILLANCE
  • RISK COMMUNICATION
  • QUESTIONS & ANSWERS
role of the clinician in vaccine safety
ROLE OF THE CLINICIAN IN VACCINE SAFETY
  • Proper storage and administration
  • Identify contraindications
  • Education
  • Report and treat Reactions
  • Refer as appropriate
  • Follow up
vaccine management
VACCINE MANAGEMENT
  • Storage and Handling
  • Timing and Spacing
  • Administration Issues
    • Equipment
    • Site of entry
special populations should talk with a health care provider before getting flu vaccine
SPECIAL POPULATIONSshould talk with a Health Care Provider before getting Flu vaccine
  • History of severe allergy to the vaccine or any vaccine component
  • History of Guillain-Barre Syndrome
  • People with moderate or severe illness
  • Pan Flu outbreak will have different considerations
cdc vaccine information statements
CDC VACCINE INFORMATION STATEMENTS
  • Public Health law requires them to be provided to parent/ vaccinee who receive childhood vaccines at each visit
  • Contains Vaccine Safety information
    • Known side effects
    • Contraindications
    • Reporting vaccine adverse events
    • Vaccine Injury Compensation
  • www.cdc.gov/vaccines/pubs/vis/default.htm
when is it safe to immunize
WHEN IS IT SAFE TO IMMUNIZE?
  • Mild illness
  • Disease exposure
  • Antibiotic therapy
  • Breast Feeding
  • Premature birth
  • Most allergies
  • Family history of vaccine reaction
vaccine reactions
VACCINE REACTIONS
  • Local Reactions
  • Systemic Reactions
  • Allergic Reactions
  • Emotional
vaccine reactions what you can do
VACCINE REACTIONSWhat You Can Do
  • React to needs
    • Physical
    • Emotional
  • Refer
    • Specialists
    • Information
  • Reassure
  • Report
  • Follow up
the bigger picture

Department of Healthand Human Services (DHHS)

National Vaccine Program Office (NVPO)

National Institutes of Health (NIH)

Centers for DiseaseControl and Prevention (CDC)

Health Resources and Services Administration (HRSA)

Food and Drug

Administration (FDA)

Immunization

Safety

Office

The Bigger Picture
vaccine injury compensation program 1 800 338 2382 www hrsa dhhs gov
VACCINE INJURY COMPENSATION PROGRAM1-800-338-2382 WWW.HRSA.DHHS.GOV
  • Covers childhood vaccines only
  • No fault basis
  • Vaccine Injury Table or
    • Proof vaccine caused problem
    • Proof vaccine aggravated existing health condition
pre licensure testing
PRE-LICENSURE TESTING
  • Laboratory tests and computer models
  • Animal tests - Test immune response. Assure no major side effects
  • Human clinical trials
    • Phase I gross toxicity
    • Phase II use/dose
    • Phase III efficacy
every lot of vaccine is tested and sampled
Every Lot Of Vaccine is Tested and Sampled
  • After approval, samples of each lot of a vaccine must be submitted to the FDA before it can be released for use.
  • Tested for safety, potency, and purity
post licensure monitoring
POST-LICENSURE MONITORING
  • Vaccine Adverse Events Reporting System (VAERS)
  • Vaccine Safety Datalink (VSD) Project
  • Clinical Immunization Safety Assessment (CISA) Centers
  • Institute of Medicine (IOM) Vaccine Safety Reviews
slide16
“Registry” of adverse events. Vaccine adverse event does not mean vaccine caused the event
  • Unified national spontaneous reporting system/passive surveillance
  • Jointly administered by CDC and FDA since 1990
  • Receives more than 20,000 reports per year

1-800-822-7967 www.vaers.hhs.gov

types of adverse events reported to vaers
TYPES OF ADVERSE EVENTS REPORTED TO VAERS
  • Vaccine reaction or side effect
  • Vaccine potentiated
  • Programmatic or human error
  • Coincidental
establishing causal link adverse event vaccine

Yes No

Yes

a

b

c

d

No

Illness or Syndrome

Establishing Causal Link: Adverse Event & Vaccine

Vaccination

VAERS = biased cell “a”

vaccine safety datalink
Vaccine Safety Datalink
  • Population under “active surveillance”
    • 8 HMOs
    • ~2.5% of the US population
  • Large-linked databases
    • Exposure (vaccination)
    • Outcome (ER, OPD, hosp, lab)
    • Covariates (birth, death certificates)
  • Scientifically rigorous hypothesis testing
clinical immunization safety assessment cisa centers
CLINICAL IMMUNIZATION SAFETY ASSESSMENT (CISA)CENTERS
  • Designed to conduct clinical research of adverse events following immunization (AEFI)
  • Activities
    • study the pathophysiology of AEFIs,
    • identify risk factors (including genetic host risk factors) associated with developing an AEFI
    • develop evidence-based guidance to assist clinicians in their decision making when assessing and managing AEFIs.
slide21
Develops globally accepted case definitions and guidelines for vaccine safety data
  • Standardizes vaccine adverse event terms
  • Used in surveillance and research
  • Definitions include:
    • Persistent crying, fever, hypotonic-hyporesponsive episode, intussusception, injection site reactions, Seizure, Anaphylaxis, SIDs, and others
  • Available free on the web

http://www.brightoncollaboration.org

hot topic in flu vaccine safety mercury and vaccines
Hot Topic in Flu Vaccine Safety Mercury and Vaccines
  • Thimerosal -mercury based preservative
  • 2001 - Precautionary measure – thimerosal removed or reduced in US vaccines
  • No evidence of harm
  • More information: www.cdc.gov/odscienceiso/concerns/thimerosal
why communicate about vaccine risks and benefits
Why Communicate About Vaccine Risks and Benefits?
  • Guidance is needed
  • People want to know
  • Legal requirement
credibility ladder
Credibility Ladder
  • High
    • Health Professionals (e.g., Nurses, Physicians)
    • Safety Professionals (e.g., Fire, Police)
    • University Scientists
  • Medium
    • Environmental Professionals
    • Media
    • Activist Groups
  • Low
    • Industry
    • Federal Government
    • Paid External Consultants
adverse event communication vincent covello 2003
Adverse Event CommunicationVincent, Covello. (2003)
  • Respect the opinion of people who believe they have been harmed
  • If the adverse event has no basis, give a complete and sympathetic explanation of why the immunization could not have caused such an effect.
  • Acknowledge uncertainty if it exists
  • Be open about an apparent apparent adverse event and discuss what measures could be taken to prevent or treat a similar event in the future.
  • Report all suspected adverse events to the Vaccine Adverse Event Reporting System
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