vaccine safety
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Vaccine Safety. Epidemiology and Prevention of Vaccine-Preventable Diseases National Immunization Program Centers for Disease Control and Prevention. Revised January 2006. Importance of Vaccine Safety. Decreases in disease risks and increased attention on vaccine risks - PowerPoint PPT PresentationTRANSCRIPT
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Vaccine Safety
Epidemiology and Prevention of Vaccine-Preventable Diseases
National Immunization ProgramCenters for Disease Control and Prevention
Revised January 2006
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Importance of Vaccine Safety• Decreases in disease risks and increased
attention on vaccine risks
• Public confidence in vaccine safety is critical– higher standard of safety is expected of vaccines
– vaccinees generally healthy (vs. ill for drugs)
– lower risk tolerance = need to search for rare reactions
– vaccination universally recommended and mandated
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Diphtheria 31,054 1 -99Measles 390,852 86 -99Mumps 21,342 338 -99Pertussis 117,998 7,867 -93Polio (wild) 4,953 0 -100Rubella 9,941 176 -98Cong. Rubella Synd. 19,177 9 -99Tetanus 1,314 35 -97Invasive Hib Disease** 24,856 112 -99
Total 566,706 8,624 -98
Vaccine Adverse Events 0 13,497 ^ +++
Disease Pre-vaccine Era* 2000 % change
* Maximum cases reported in pre-vaccine era + Estimated because no national reporting existed in the prevaccine era^ Adverse events after vaccines against diseases shown on Table = 5,296** Invasive type b and unknown serotype
Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases and
Vaccine Adverse Events, United States
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Importance of Vaccine Safety
• Ongoing safety monitoring needed for the development of sound policies and recommendations
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Prelicensure Vaccine Safety Studies
• Laboratory
• Animals
• Humans
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Prelicensure Human Studies
• Phases I, II, III trials
• Common reactions are identified
• Vaccines are tested in thousands of persons before being licensed and allowed on the market
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Postlicensure Surveillance
• Identify rare reactions
• Monitor increases in known reactions
• Identify risk factors for reactions
• Identify vaccine lots with unusual rates or types of events
• Identify signals
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Postlicensure Vaccine Safety Activities
• Phase IV Trials –~10,000 participants–better but still limited
• Large-Linked Databases
• Clinical Immunization Safety Assessment Network
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Vaccine Adverse Event Reporting System (VAERS)
• National reporting system
• Jointly administered by CDC and FDA
• Passive (depends on healthcare providers and others to report)
• Receives ~15,000 reports per year
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Vaccine Adverse Event Reporting System (VAERS)
• Detects– new or rare events– increases in rates of known side effects– patient risk factors
• Additional studies required to confirm VAERS signals
• Not all reports of adverse events are causally related to vaccine
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Adverse Event Classification
• Vaccine-induced
• Vaccine-potentiated
• Programmatic error
•Coincidental
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Vaccine Safety Datalink (VSD)
• Large-linked database
• Links vaccination and health records
• “Active surveillance”–8 HMOs– ~2% of the U.S. population
• Powerful tool for monitoring vaccine safety
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Clinical Immunization Safety Assessment (CISA) Network
• Improve understanding of vaccine safety issues at individual level
• Evaluate persons who experience adverse health events
• Gain better understanding of events
• Develop protocols for healthcare providers
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Vaccine Injury Compensation Program (VICP)
• Established by National Childhood Vaccine Injury Act (1986)
• “No fault” program
• Covers all routinely recommended childhood vaccines
• Vaccine Injury Table
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The Provider’s Role
• Immunization providers can help to ensure the safety and efficacy of vaccines through proper:
–vaccine storage and administration
–timing and spacing of vaccine doses
–observation of contraindications and precautions
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The Provider’s Role
• Immunization providers can help to ensure the safety and efficacy of vaccines through proper:
–management of vaccine side effects
–reporting of suspected side effects to VAERS
–vaccine benefit and risk communication
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Contraindication
A condition in a recipient that increases the chance of a serious adverse reaction
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Precaution
A condition in a recipient that might
• Increase the chance or severity of an adverse reaction, or
• Compromise the ability of the vaccine to produce immunity
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Invalid Contraindications to Vaccination
• Minor illness• Mild/moderate local reaction or fever
following a prior dose• Antimicrobial therapy• Disease exposure or convalescence• Pregnancy or immunosuppression in the
household• Premature birth• Breastfeeding• Allergies to products not in vaccine• Family history (unrelated to
immunosuppression)
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Benefit and Risk Communication
• Opportunities for questions should be provided before each vaccination
• Vaccine Information Statements (VISs)–must be provided before each dose
of vaccine
– public and private providers
– available in multiple languages
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National Immunization Program
Contact Information
• Telephone 800.CDC.INFO
• Email [email protected]
• Website www.cdc.gov/nip