Document text
Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases
Maternal RSV vaccine safety monitoring in the
Vaccine Adverse Event Reporting System (VAERS)
and V -safe
Pedro L. Moro, MD, MPH
Immunization Safety Office
Centers for Disease Control and Prevention (CDC)
Advisory Committee for Immunization Practices
September 22, 2023
2Co-managed by
CDC and FDA
Vaccine Adverse Event Reporting System (VAERS)
Vaccine Adverse
Event Reporting
System
+
http://vaers.hhs.gov
3VAERS
Strengths
▪National data
▪Accepts reports from anyone
▪Rapidly detects safety signals
▪Can detect rare adverse events
▪Data available to publicLimitations
▪Reporting bias
▪Inconsistent data quality and completeness
▪Lack of unvaccinated comparison group
▪Generally cannot assess causality
•VAERS accepts all reports from all reporters without making judgments on
causality or judging clinical seriousness of the event
•As a hypothesis generating system, VAERS identifies potential vaccine safety
concerns that can be studied in more robust data systems
4Approaches to analyzing VAERS data
▪For more than a decade VAERS has been used as part of vaccine safety
surveillance for vaccines used in pregnancy (e.g., influenza, Tdap, COVID -19)
•Descriptive analysis
oClinical review of individual reports
oAggregate descriptions of automated data (e.g., counts of reported adverse events)
oCalculation of reporting rates for pregnancy outcomes (if doses of RSV vaccine
administered in pregnancy or vaccination coverage data available are available)
•Statistical analysis
oHistorical approaches have included data mining; under discussion
*Reported adverse events are coded using Medical Dictionary for Regulatory Activities terms ( https://www.meddra.org/ )
5Search for RSV pregnancy reports and clinical review
▪Search of reports:
•Specific Medical Dictionary for Regulatory Activities (MedDRA) codes: exposure during
pregnancy, drug exposure during pregnancy, maternal exposure during pregnancy
•Affirmative answer on Question 8 in VAERS form (pregnancy status)
•String search of text fields (symptoms, pre -existing illness, medical history) for ‘ preg ’
▪Medical records requested for ALL pregnancy reports
▪Clinicians review reports to confirm they are pregnancy reports and
categorize the main adverse event/s of interest
VAERS surveillance of adverse events of special interest (AESI)
after RSV vaccination
▪Primary AESIs
•Selected for historical, theoretical, or observed safety concerns (i.e., in clinical trials)
•VAERS will obtain medical records for all reports (serious1and non -serious)
•CDC will review records and abstract clinically important information
•AESIs may be added to or removed from the list as appropriate
▪Secondary AESIs
•Monitored via periodic (e.g., weekly) automated data tables
•Can be added to primary AESI list if safety concerns identified
1Based on the Code of Federal Regulations if one of the following is reported: death, life -threatening illness, hospitalization o r prolongation of
hospitalization , permanent disability, congenital anomaly or birth defect
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Adverse events of special interest (AESI) after RSV vaccines
Primary AESIs
▪Outcomes of general interest
• Death
▪Neurologic/neuroinflammatory conditions
• Guillain -Barre Syndrome (GBS), including Miller
Fisher variant
• Acute disseminated encephalomyelitis (ADEM)
• Transverse myelitis (TM)
• Chronic inflammatory demyelinating
polyneuropathy (CIDP)
▪Allergic reactions
• Anaphylaxis
▪Cardiac conditions
•Atrial fibrillation
•Other supraventricular tachycardias (SVT)Secondary AESI s
▪Neurologic/neuroinflammatory conditions
• Optic neuritis
• Multiple sclerosis
• Bell’s palsy
• Encephalitis/Encephalomyelitis
• Meningitis/Meningoencephalitis
• Myelitis
▪ Other conditions
• Vaccination errors
• AEs following simultaneous administration with
COVID -19, inactivated influenza, or other adult
vaccinesWill be monitored in VAERS for all RSV vaccines, including for reports among pregnant persons
8Pregnancy -specific outcomes to be monitored in
VAERS and abstracted after maternal RSV vaccine
▪Pregnancy reports after maternal RSV vaccine
•Premature/preterm birth
•Stillbirth
•Spontaneous abortion
•Gestational diabetes
•Preeclampsia/eclampsia/gestational hypertension
•Birth defects
•Maternal and infant deaths
•Other selected adverse infant outcomes/AEs
9▪New version of V -safe developed starting Summer 2023
•Leverages existing CDC IT infrastructure
•Includes email and text messaging options
•First use for RSV vaccines received by persons aged 60 and older
•Use for maternal RSV vaccines planned for later this fall
▪V-safe objectives:
1. Characterize local and systemic reactogenicity during days 0 -7 after vaccination
2. Characterize health impacts during a 6 -week post -vaccination follow -up period
3. Identify participants who report medically attended events after vaccination and
encourage completion of a VAERS report
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY: 1 -888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.Thank you