Vaccine Safety Epidemiology and Prevention of Vaccine-Preventable

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1. Vaccine Safety Epidemiology and Prevention of Vaccine-Preventable
2. Importance of Vaccine SafetyDecreases in disease risks
3. * Maximum cases reported in pre-vaccine
4. Importance of Vaccine SafetyOngoing safety monitoring needed for the development of sound policies and recommendations
5. Prelicensure Vaccine Safety StudiesLaboratoryAnimalsHumans
6. Prelicensure Human StudiesPhases I, II, III trialsCommon
7. Postlicensure SurveillanceIdentify rare reactionsMonitor increases in known
8. Postlicensure Vaccine Safety ActivitiesPhase IV Trials ~10,000 participantsbetter but still limitedLarge-Linked DatabasesClinical Immunization Safety Assessment Network
9. Vaccine Adverse Event Reporting System (VAERS) National
10. Vaccine Adverse Event Reporting System (VAERS) Detectsnew
11. Adverse Event ClassificationVaccine-inducedVaccine-potentiatedProgrammatic errorCoincidental
12. Vaccine Safety Datalink (VSD)Large-linked databaseLinks vaccination and
13. Clinical Immunization Safety Assessment (CISA) NetworkImprove understanding
14. Vaccine Injury Compensation Program (VICP)Established by
15. The Provider’s RoleImmunization providers can help to
16. The Provider’s RoleImmunization providers can help to
17. Contraindication A condition in a recipient that increases the chance of a serious adverse reaction
18. Precaution A condition in a recipient that
19. Invalid Contraindications to VaccinationMinor illnessMild/moderate local
20. Benefit and Risk CommunicationOpportunities for questions should
21. National Immunization Program Contact InformationTelephone 800.CDC.INFO Email nipinfo@cdc.gov Website www.cdc.gov/nip
22. Скачать презентанцию

Importance of Vaccine SafetyDecreases in disease risks and increased attention on vaccine risksPublic confidence in vaccine safety is criticalhigher standard of safety is expected of vaccinesvaccinees generally healthy (vs. ill

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Vaccine Safety Epidemiology and Prevention of Vaccine-Preventable

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Слайд 1Vaccine Safety
Epidemiology and Prevention of Vaccine-Preventable Diseases

National Immunization Program
Centers for

Disease Control and Prevention
Revised January 2006

Vaccine SafetyEpidemiology and Prevention of Vaccine-Preventable DiseasesNational Immunization ProgramCenters for Disease Control and PreventionRevised January 2006

Слайд 2Importance 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

Importance of Vaccine SafetyDecreases in disease risks and increased attention on vaccine risksPublic confidence in vaccine safety

Слайд 3* 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

* Maximum cases reported in pre-vaccine era + Estimated because no national reporting existed in the

Слайд 4Importance of Vaccine Safety
Ongoing safety monitoring needed for the development

of sound policies and recommendations

Слайд 5Prelicensure Vaccine Safety Studies
Laboratory
Animals
Humans

Слайд 6Prelicensure 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

Prelicensure Human StudiesPhases I, II, III trialsCommon reactions are identifiedVaccines are tested in thousands of persons before

Слайд 7Postlicensure 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

Postlicensure SurveillanceIdentify rare reactionsMonitor increases in known reactionsIdentify risk factors for reactionsIdentify vaccine lots with unusual rates

Слайд 8Postlicensure Vaccine Safety Activities
Phase IV Trials
~10,000 participants
better but still

limited
Large-Linked Databases
Clinical Immunization Safety Assessment Network

Postlicensure Vaccine Safety ActivitiesPhase IV Trials ~10,000 participantsbetter but still limitedLarge-Linked DatabasesClinical Immunization Safety Assessment Network

Слайд 9Vaccine 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

Vaccine Adverse Event Reporting System (VAERS) National reporting systemJointly administered by CDC and FDAPassive (depends on

Слайд 10Vaccine 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

Vaccine Adverse Event Reporting System (VAERS) Detectsnew or rare eventsincreases in rates of known side effectspatient risk

Слайд 11Adverse Event Classification
Vaccine-induced
Vaccine-potentiated
Programmatic error
Coincidental

Слайд 12Vaccine 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

Слайд 13Clinical 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

Clinical Immunization Safety Assessment (CISA) NetworkImprove understanding of vaccine safety issues at individual levelEvaluate persons who experience

Слайд 14Vaccine Injury Compensation Program (VICP)
Established by National Childhood Vaccine Injury

Act (1986)
“No fault” program
Covers all routinely recommended childhood vaccines
Vaccine Injury

Table

Vaccine Injury Compensation Program (VICP)Established by National Childhood Vaccine Injury Act (1986)“No fault” programCovers all routinely

Слайд 15The 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

The Provider’s RoleImmunization providers can help to ensure the safety and efficacy of vaccines through proper:vaccine storage

Слайд 16The 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

The Provider’s RoleImmunization providers can help to ensure the safety and efficacy of vaccines through proper:management of

Слайд 17Contraindication
A condition in a recipient that increases the

chance of a serious adverse reaction

Слайд 18Precaution
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

Precaution A condition in a recipient that might Increase the chance or severity of an adverse reaction,

Слайд 19Invalid 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)

Invalid Contraindications to VaccinationMinor illnessMild/moderate local reaction or fever following a prior doseAntimicrobial therapyDisease exposure or

Слайд 20Benefit 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

Benefit and Risk CommunicationOpportunities for questions should be provided before each vaccinationVaccine Information Statements (VISs)must be

Слайд 21National Immunization Program Contact Information
Telephone 800.CDC.INFO
Email nipinfo@cdc.gov
Website www.cdc.gov/nip

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Vaccine Safety Epidemiology and Prevention of Vaccine-Preventable

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Слайд 1Vaccine SafetyEpidemiology and Prevention of Vaccine-Preventable DiseasesNational Immunization ProgramCenters for

Disease Control and PreventionRevised January 2006

Слайд 2Importance of Vaccine SafetyDecreases in disease risks and increased attention

on vaccine risksPublic confidence in vaccine safety is criticalhigher standard

Слайд 3* Maximum cases reported in pre-vaccine era + Estimated

because no national reporting existed in the prevaccine era^ Adverse

Слайд 4Importance of Vaccine SafetyOngoing safety monitoring needed for the development

of sound policies and recommendations

Слайд 5Prelicensure Vaccine Safety StudiesLaboratoryAnimalsHumans

Слайд 6Prelicensure Human StudiesPhases I, II, III trialsCommon reactions are identifiedVaccines

are tested in thousands of persons before being licensed and

Слайд 7Postlicensure SurveillanceIdentify rare reactionsMonitor increases in known reactionsIdentify risk factors

for reactionsIdentify vaccine lots with unusual rates or types of

Слайд 8Postlicensure Vaccine Safety ActivitiesPhase IV Trials ~10,000 participantsbetter but still

limitedLarge-Linked DatabasesClinical Immunization Safety Assessment Network

Слайд 9Vaccine Adverse Event Reporting System (VAERS) National reporting systemJointly administered

by CDC and FDAPassive (depends on healthcare providers and others

Слайд 10Vaccine Adverse Event Reporting System (VAERS) Detectsnew or rare eventsincreases

in rates of known side effectspatient risk factors Additional studies

Слайд 11Adverse Event ClassificationVaccine-inducedVaccine-potentiatedProgrammatic errorCoincidental

Слайд 12Vaccine Safety Datalink (VSD)Large-linked databaseLinks vaccination and health records“Active surveillance”8

HMOs ~2% of the U.S. populationPowerful tool for monitoring vaccine

Слайд 13Clinical Immunization Safety Assessment (CISA) NetworkImprove understanding of vaccine safety

issues at individual levelEvaluate persons who experience adverse health eventsGain

Слайд 14Vaccine Injury Compensation Program (VICP)Established by National Childhood Vaccine Injury

Act (1986)“No fault” programCovers all routinely recommended childhood vaccinesVaccine Injury

Слайд 15The Provider’s RoleImmunization providers can help to ensure the safety

and efficacy of vaccines through proper:vaccine storage and administrationtiming and

Слайд 16The Provider’s RoleImmunization providers can help to ensure the safety

and efficacy of vaccines through proper:management of vaccine side effectsreporting

Слайд 17Contraindication A condition in a recipient that increases the