Vaccine Safety

Август 8, 2022

Содержание

2. Importance of Vaccine Safety Decreases in disease risks and increased attention on vaccine risks Public confidence
3. * Maximum cases reported in pre-vaccine era + Estimated because no national reporting existed in the
4. Importance of Vaccine Safety Ongoing safety monitoring needed for the development of sound policies and recommendations
5. Prelicensure Vaccine Safety Studies Laboratory Animals Humans
6. Prelicensure Human Studies Phases I, II, III trials Common reactions are identified Vaccines are tested in
7. Postlicensure Surveillance Identify rare reactions Monitor increases in known reactions Identify risk factors for reactions Identify
8. Postlicensure Vaccine Safety Activities Phase IV Trials ~10,000 participants better but still limited Large-Linked Databases Clinical
9. Vaccine Adverse Event Reporting System (VAERS) National reporting system Jointly administered by CDC and FDA Passive
10. Vaccine Adverse Event Reporting System (VAERS) Detects new or rare events increases in rates of known
11. Adverse Event Classification Vaccine-induced Vaccine-potentiated Programmatic error Coincidental
12. Vaccine Safety Datalink (VSD) Large-linked database Links vaccination and health records “Active surveillance” 8 HMOs ~2%
13. Clinical Immunization Safety Assessment (CISA) Network Improve understanding of vaccine safety issues at individual level Evaluate
14. Vaccine Injury Compensation Program (VICP) Established by National Childhood Vaccine Injury Act (1986) “No fault” program
15. The Provider’s Role Immunization providers can help to ensure the safety and efficacy of vaccines through
16. The Provider’s Role Immunization providers can help to ensure the safety and efficacy of vaccines through
17. Contraindication A condition in a recipient that increases the chance of a serious adverse reaction
18. Precaution A condition in a recipient that might Increase the chance or severity of an adverse
19. Invalid Contraindications to Vaccination Minor illness Mild/moderate local reaction or fever following a prior dose Antimicrobial
20. Benefit and Risk Communication Opportunities for questions should be provided before each vaccination Vaccine Information Statements
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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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* 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

Vaccine Safety

Содержание

Importance of Vaccine SafetyDecreases in disease risks and increased attention on

* Maximum cases reported in pre-vaccine era + Estimated because no

Importance of Vaccine SafetyOngoing safety monitoring needed for the development of

Prelicensure Vaccine Safety StudiesLaboratoryAnimalsHumans

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

Postlicensure SurveillanceIdentify rare reactionsMonitor increases in known reactionsIdentify risk factors for

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

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

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

Adverse Event ClassificationVaccine-inducedVaccine-potentiatedProgrammatic errorCoincidental

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

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

Vaccine Injury Compensation Program (VICP)Established by National Childhood Vaccine Injury Act

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

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

Contraindication A condition in a recipient that increases the chance of

Precaution A condition in a recipient that might Increase the chance

Invalid Contraindications to VaccinationMinor illnessMild/moderate local reaction or fever following a

Benefit and Risk CommunicationOpportunities for questions should be provided before each

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Importance of Vaccine Safety
Decreases in disease risks and increased attention on

* Maximum cases reported in pre-vaccine era
+ Estimated because no

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

Prelicensure Vaccine Safety Studies
Laboratory
Animals
Humans

Prelicensure Human Studies
Phases I, II, III trials
Common reactions are identified
Vaccines are

Postlicensure Surveillance
Identify rare reactions
Monitor increases in known reactions
Identify risk factors for

Postlicensure Vaccine Safety Activities
Phase IV Trials
~10,000 participants
better but still limited
Large-Linked

Vaccine Adverse Event Reporting System (VAERS)
National reporting system
Jointly administered by

Vaccine Adverse Event Reporting System (VAERS)
Detects
new or rare events
increases in

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

Vaccine Safety Datalink (VSD)
Large-linked database
Links vaccination and health records
“Active surveillance”
8 HMOs

Clinical Immunization Safety Assessment (CISA) Network
Improve understanding of vaccine safety issues

Vaccine Injury Compensation Program (VICP)
Established by National Childhood Vaccine Injury Act

The Provider’s Role
Immunization providers can help to ensure the safety and

The Provider’s Role
Immunization providers can help to ensure the safety and

Contraindication
A condition in a recipient that increases the chance of

Precaution
A condition in a recipient that might
Increase the chance

Invalid Contraindications to Vaccination
Minor illness
Mild/moderate local reaction or fever following a

Benefit and Risk Communication
Opportunities for questions should be provided before each