Document text
Update on CDC’s COVID-19 Vaccine Safety Monitoring
Sarah Meyer, MD MPH
Director, CDC’s Immunization Safety Office
June 25, 2025
1
Key Points
• CDC and interagency partners launched an extensive vaccine safety monitoring
program for COVID-19 vaccines
• Many potential safety outcomes were rigorously assessed through complementary passive and active systems
• Myocarditis is causally associated with mRNA COVID-19 vaccines
-Adverse events common to all vaccines were also observed (e.g., local and
systemic reactions, allergic reactions)
• CDC continues to monitor the safety of COVID-19 vaccines
2
Interagency collaboration to
monitor post-licensure safety
CDC
monitoring
starts
3
CDC’s Immunization Safety Office Monitors Vaccine Safety
Through Strong, Complementary Systems
VAERS VSD CISA Project V-safe
1990 1990 2001 2020
Systems work together to rapidly detect and assess potential
safety concerns to help inform public health actions
4
VAERS
Vaccine Adverse Event Reporting System (VAERS)
The Nation’s Early Warning System for Vaccine Safety
• Co-managed by CDC and FDA
• Nationwide spontaneous reporting system that can rapidly
detect safety signals, including rare events
• Mandated reporting by healthcare providers and
manufacturers, and encouraged from anyone (e.g., patients)
• A report to VAERS does not mean that a vaccine caused an adverse event
• Used for signal detection and hypothesis generation, not
typically for assessing causality
5
Vaccine Safety Datalink (VSD)
Collaborative Model for High-Quality Vaccine Safety Data
VSD • 13 integrated healthcare organizations, covering >15.5
million people per year
• Acti
ve monitoring using electronic medical records (EMR)
and chart reviews
• Rapid monitoring for pre-specified events as well as
monitoring for unexpected events
• Can detect and assess safety signals
• Develops innovative methods for monitoring safety
6
Clinical Immunization Safety Assessment (CISA) Project
Network to Guide Vaccine Safety from the Individual to Population Level
CISA Project • 8 medical research centers with vaccine safety experts
• Pro
vides expert clinical consultation on complex
immunization issues
• Conducts clinical research on vaccine safety
• Helps to inform CDC public health guidance on clinical
immunization safety issues
7
V-safe: After-Vaccination Health Checker
CDC’s Tool for Direct-to-Consumer Vaccine Safety Monitoring
V-safe • Web-based, self-reported active monitoring system
established during COVID-19 pandemic
• Can ser
ve as earliest source of information for new
vaccines and in populations excluded from clinical trials
-Used to recruit women for COVID-19 Vaccine Pregnancy
Registry
• Important tool for emergency preparedness and response
• Integrated with VAERS to help streamline reporting of
ser
ious adverse events
8
CDC’s Comprehensive Approach to Studying COVID-19 Vaccine Safety
Surveillance Epidemiologic studies Clinical Research Pregnancy Registry
Ana
lyze spontaneously Assess specific safety Safety studies to guide Longitudinal assessment of
reported events questions clinical practice maternal and infant outcomes
Rapid cycle analyses Dat a mining Pati ent surveys
Qui
ckly detect potential Ass
ess >60,000 outcomes Ass
ess symptoms and
con
cerns for investigation for
unexpected events hea
lth impacts
9
CDC Summary of COVID-19 Vaccine Safety Data Based on
Comprehensive Body of Evidence Collected
December 2020 – June 2025
17 28 29 114 ~9.6M
VaST work
group reports Advisory
meeting
presentations
(ACIP, VRBPAC) Morbidity and
Mortality Weekly
Report (MMWR)
publications Published
manuscripts Participants
enrolled in V-safe
Vaccine doses distributed in U.S. ~1B
ACIP: Advisory Committee on Immunization Practices; VRBPAC: Vaccines and Related Biological Products Advisory Committee; VaST: Vaccine Safety Technical Work Group 10
mRNA
Pfizer-BioNTech
Moderna Three Types of COVID-19 Vaccine Received FDA
Authorization or Approval in the United States
Protein-based
Novavax
Viral Vector
Janssen
11
-Janssen Use Limited After Detection of Safety Concerns in
April 2021, and No Longer Authorized in U.S. as of June 2023
Protein-based
Novavax
mRNA
Pfizer-BioNTech
Moderna
EUA: Emergency Use Authorization
Oliver S, et al. Development of COVID-19 vaccine policy — United States, 2020–2023 - ScienceDirect
Viral Vector
Janssen
• By April 2021, VAERS detects 6 reports of
thrombosis w/ thrombocytopenia
syndrome (TTS); FDA and CDC issue a 10
day pause in use before resuming
• In December 2021, ACIP issues preferential
recommendation for mRNA vaccines
• In June 2023, FDA revokes EUA
12
Janssen Use Limited After Detection of Safety Concerns in
April 2021, and No Longer Authorized in U.S. as of June 2023
Protein-based
Novavax
mRNA
Pfizer-BioNTech
Moderna
EUA: Emergency Use Authorization
Oliver S, et al. Dev
elopment of COVID-19 vaccine policy — United States, 2020–2023 - ScienceDirect
Viral Vector
Janssen
Highlights an example of
federal safety systems
working to rapidly
identify and mitigate a
vaccine safety issue
13
mRNA
Pfizer-BioNTech
Moderna -Limited Post-Authorization Safety Data Available for Novavax
Protein-based
Novavax
Limited post authorization safety data
available:
• Authorized later than other products (July 2022)
• Limited uptake in the U.S.
mRNA
Pfizer-BioNTech
Moderna
Viral Vector
Janssen
14
mRNA
Pfizer-BioNTech
Moderna Focus on mRNA COVID-19 Vaccines For This Presentation
Protein-based
Novavax
Viral Vector
Janssen
15
Monitoring Safety of COVID-19 Vaccines
What we have learned
16
16
CDC Has Evaluated At Least 65 Specific Outcomes to Assess COVID-19
Vaccine Safety Using a Variety of Systems and Epidemiologic Methods
Acute myocardial infarction • ICU admission • Acute disseminated encephalomyelitis • Thrombotic
thrombocytopenic Purpura • Encephalopathy • Gestational diabetes • Trigeminal neuralgia and
related disorders • Meningitis • Deep vein thrombosis • Anaphylaxis • Thrombocytopenia •
Postmenopausal bleeding • Myocarditis • Cataplexy • Myelitis • Chronic inflammatory demyelinating
polyneuropathy • Non-COVID mortality • Pulmonary embolism • Stillbirth • Major birth defects •
Encephalitis •Local reactions •Vaccine-Associated Enhanced Disease after COVID-19 Vaccines
• Hemorrhagic stroke • Administration errors • Acute respiratory distress syndrome • Narcolepsy •
Perinatal death •Bell's Palsy •Thrombosis with thrombocytopenia syndrome •Multiple sclerosis
• Systemic reaction
s • Spontaneous abortion • Ataxia • Hospitalization • Acute disseminated
encephalomyelitis • Menstrual irregularities • Immune thrombocytopenic purpura • All-cause
mortality • Pericarditis •Early childhood infections in infants of vaccinated mothers •Ischemic stroke
• Shoulder injuries • Multisystem Inflammatory Syndrome in Children • Multisystem Inflammatory
Syndrome in Adults • Tinnitus • Disseminated intravascular coagulation • Acute respiratory distress
syndrome • Venous thromboembolism • Arthritis • Seizure • Kawasaki Disease • Arthralgia •
Menstrual irregularities •NICU admission •Chronic inflammatory demyelinating polyneuropathy
•Small-for-gestational age •Post-COVID conditions •Trigeminal neuralgia and related disorders
17
Weekly, Sequential Monitoring of
Pre-Specified Outcomes in the VSD
• Rapid cycle analyses (RCAs) conducted weekly since December 2020
of up to 23 pre-specified outcomes among over 12 million people
-Outcomes selected based on clinical trial data, known safety
findings with other vaccines, or biological plausibility
• Seq
uential statistical testing using automated ICD-10-CM codes
-Compare incidence in vaccinated people during post-vaccination
risk interval vs. vaccinated people in a comparison window
• If p
otential “statistical signal” detected, additional analyses and/or
chart reviews conducted
-System designed to be sensitive; not all detected signals
represent a true safety concern
18
Evaluation of Statistical Signals Detected for mRNA COVID-19
Vaccines through VSD’s Rapid Cycle Analyses – 2020-2025
8 statistical signals detected
Acute myocardial infarction
Seizure
Age 18+ years 18-64 years
Immune Thrombocytopenic Purpura
Age 65+ years
Venous thromboembolism
Age 12+ years Guillain-Barré syndrome
Age 65+ years
Bell’s Palsy
Age 12+ years
Ischemic stroke
Age 50+ years
Myocarditis
Age 12+ years
COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic – ScienceDirect and CDC unpublished data 19
Evaluation of Statistical Signals Detected for mRNA COVID-19
Vaccines through VSD’s Rapid Cycle Analyses – 2020-2025
Acute myocardial infarction
Age 65+ years
Venous thromboembolism
Age 12+ years
Bell’s Palsy
Age 12+ years
Ischemic stroke
Age 50+ years
Guillain-Barré syndrome
Age 65+ years
Seizure
18-64 years
Immune Thrombocytopenic Purpura
Age 65+ years
Myocarditis
Age 12+ years 8 statistical signals detected Further investigations
Chart reviews
Trend analysis
Additional studies
(e.g., self-controlled
case series)
Query other
systems
COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic – ScienceDirect and CDC unpublished data 20
Evaluation of Statistical Signals Detected for mRNA COVID-19
Vaccines through VSD’s Rapid Cycle Analyses – 2020-2025
Acute myocardial infarction
Age 65+ years
Venous thromboembolism
Age 12+ years
Bell’s Palsy
Age 12+ years
Ischemic stroke
Age 50+ years
Guillain-Barré syndrome
Age 65+ years
Seizure
18-64 years
Immune Thrombocytopenic Purpura
Age 65+ years
Myocarditis
Age 12+ years 8 statistical signals detected Further investigations
system
Chart reviews
Trend analysis
Additional studies
(e.g., self-controlled
case series)
Query other
COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic – ScienceDirect and CDC unpublished data
Increased risk for myocarditis
following mRNA COVID-19 vaccines
No clear or consistent evidence of
a safety concern for the others
Safety assessment
21
38
6
22Myocarditis Following mRNA COVID-19 Vaccination Among
People Ages 12–39 Years in the Vaccine Safety Datalink
Incidence of myocarditis within 7 days of vaccination per million mRNA vaccine doses administered
*
6 38
25
2 5
2
Dose 1
Original monovalent Dose 2
Original monovalent Booster
Original monovalent Bivalent
2020-2021 2021-2022 2022-2023 2023-2024 2024-2025 *
Background
<2 per million higher in males
• Myocarditis rare in children aged <12 years
and adults aged ≥50 years
* • Rates peak at age 16-17 years and are
rate
*St
atistically significant increased rate ratio in vaccinated concurrent comparator analysis. Source: CDC Immunization Safety Office 22
Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination in
FDA’s Biologics Effectiveness and Safety System (BEST), 2023—2024 Season
Incidence (cases per million doses) during days 1—7 following vaccine administration
FDA issued Safety Labeling Change (SLC) notification letters to the manufacturers
on April 17, 2025, and initiated the SLC process to include new safety information on myocarditis and pericarditis for
Comirnaty and Spikevax. Under the labeling negotiations, FDA has notified sponsors of the above data
2025 Safety and Availability Communications | FDA ; Information courtesy of FDA 23
Follow-up CDC Studies Demonstrate Most Adolescents
and Young Adults Have Recovered From Myocarditis
• Surveys of individuals aged 12-29 years with myocarditis after mRNA COVID-19 vaccine, and their
healthcare providers, for whom a VAERS report was filed during January 12-November 5, 2021
• Based on cardiologist or other healthcare provider assessment:
83% >90%
Fully or probably fully recovered by at Overall, fully or probably fully recovered by
leas
t 90 days after myocarditis onset at least a 1 year after myocarditis onset
• Among patients with abnormal cardiac MRI at 1-year evaluation, most common abnormality was late ga
dolinium enhancement
-clinical significance unclear; majority considered recovered and cleared for all physical activity
• No k
nown deaths or cardiac transplants
Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study - The Lancet Child & Adolescent
Health ; Outcomes at ≥1 year based on unpublished data 24
COVID-19 Vaccine Safety in Children Ages 6 Months to 11 Years
• Risk of myocarditis following COVID-19 vaccines in children aged <12 years is low,
par
ticularly for those aged 6 months to 5 years
-Active, sequential analyses in the Vaccine Safety Datalink have demonstrated no statistical signals
for
myocarditis in children
-No confirmed myocarditis cases in children aged <5 years in VAERS or VSD
• Rapid cycle analyses in the VSD demonstrate no increased risks for 22 other pre -
specified outcomes following COVID-19 vaccination
• Evaluations to assess multisystem inflammatory syndrome in children (MIS-C) following COVID-19 vaccination demonstrated that most patients had evidence of preceding SARS-CoV-2 infection
Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years | Pediatrics | American Academy of Pediatrics ; Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023 |
MMWR ; COVID-19 Vaccine Safety First Year Findings in Adolescents | Pediatrics | American Academy of Pediatrics ; Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5–11 Years — United States, October 12–January 1, 2023 |
MMWR ; COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months–5 Years — United States, June 18, 2022–August 21, 2022 | MMWR ; Safety of COVID-19 mRNA Vaccination Among Young Children in the Vaccine Safety Datalink | Pediatrics | American Academy of
Pediatrics ; Surveillance for Multisystem Inflammatory Syndrome in US Children Aged 5-11 Years Who Received Pfizer-BioNTech COVID-19 Vaccine, November 2021 through March 2022 – PubMed ; Reported cases of multisystem inflammatory syndrome in children aged
12–20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation - The Lancet Child & Adolescent Health 25
Majority of COVID-19 Vaccine Reports to VAERS in Children Aged
<12 Years Include at Least One Vaccine Administration Error
Approximately 77% of reports in children aged 6 months-4 years and 70% of reports in children aged 5-11 years
related to administration errors between October 21, 2021 – April 30, 2025
Data source: https://wonder.cdc.gov
VAERS reports may include more than one administration error type 26
CDC Is Expanding Its Work to Prevent Vaccine
Administration Errors
Vaccine Administration Protocols | CDC 27
Evaluating Safety of COVID-19 Vaccines in Pregnant Women
• >23,000 pregnant women CDC COVID-19 Vaccine Pregnancy Registry
• 7 analyses
• Ob
servational studies based on survey
and medical record information
• >45,000 pregnant women Vaccine Safety Datalink
• 11 an
alyses to date
• Cohort
, case-control, and surveillance
evaluations
28
COVID-19 Vaccine Safety During Pregnancy
Across CDC studies, evidence shows NO increased risk of:
Materna
l outcomes Pregnancy outcomes Infant outcomes
25 medically-attended Miscarriage Major birth defects
adverse events Stillbirth Neonatal ICU admission
Serious adverse events Preterm birth Infant death
Pregnancy-related Small-for-gestational age
condi
tions
Maternal ICU admission
Evaluation of Acute Adverse Events after Covid-19 Vaccination during Pregnancy | New England Journal of Medicine ; Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth — Eight Integrated Health Care
Organizations, United States, December 15, 2020–July 22, 2021 | MMWR ; Receipt of mRNA Covid-19 Vaccines and Risk of Spontaneous Abortion | New England Journal of Medicine ; Spontaneous Abortion Following COVID-19 Vaccination During
Pregnancy | Public Health | JAMA | JAMA Network ; COVID-19 Booster Vaccination in Early Pregnancy and Surveillance for Spontaneous Abortion; Coronavirus Disease 2019 (COVID-19) Vaccination and Stillbirth in the Vaccine Safety Datalink ;
Medically Attended Acute Adverse Events in Pregnant Women ; Obstetric Complications and Birth Outcomes After Antenatal Coronavirus Disease 2019 (COVID-19) Vaccination; COVID-19 Vaccination in the First Trimester and Major Structural Birth
Defects Among Live Births ; Accumulating Robust Evidence for Reducing Vaccine Hesitancy in Early Pregnancy—Reply 29
Address Vaccine Safety
Tinnitus
• Conducted data mining to assess tinnitus:
-VAERS empirical Bayesian data mining did not find
disproportionate reporting of tinnitus
-VSD tree-based data mining found no signals for tinnitus
• Taken together, findings do not support an
inc
reased risk of tinnitus after COVID-19 vaccine
Postmenopausal Bleeding After Coronavirus Disease 2019 (COVID-19) Vaccination: Vaccine Adverse Event Reporting System – PubMed
Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to v-safe active surveillance, USA in December, 2020-January, 2022: an observational cohort study – PubMed Tinnitus after COVID-19 vaccination: Findings from the vaccine adverse event reporting system and the vaccine safety datalink - ScienceDirect Examples of CDC Studies to
Concerns from the Public
Abnormal uterine bleeding
• Conducted studies in VAERS, VSD, and v-safe for
ab
normal uterine bleeding
• VSD studies demonstrated:
-Availability of COVID-19 vaccines was not associated
with a change in incidence of medically-attended
abnormal uterine or post-menopausal bleeding
-Receipt of COVID-19 vaccine not associated with
greater bleeding severity
Abnormal uterine bleeding diagnoses and care following COVID-19 vaccination – ScienceDirect
Postmenopausal bleeding after COVID-19 vaccination – PubMed
30
Safety Monitoring of Death Reports Following mRNA COVID -
19 Vaccination in VAERS
• As of May 30, 2025, there have been 19,417 domestic deaths reported to VAERS
after COVID-19 vaccination
• Important considerations related to evaluation of death reports in VAERS
-FDA Emergency Use Authorizations and CDC COVID-19 Vaccination Provider Enrollment
Agreements required healthcare provider to report all deaths following COVID-19 vaccination to
VAERS, regardless of cause or circumstances surrounding death (requirement does not apply to
oth
er vaccines)
-VAERS generally cannot assess causality of adverse reports, including deaths
• We conducted an evaluation of deaths following mRNA COVID-19 vaccination in VAERS
thr
ough January 31, 2023
Vaccine Adverse Event Reporting System. VAERS Reporting Information for COVID-19 Vaccines. https://vaers.hhs.gov/reportevent.html 31
Safety Monitoring of Death Reports Following mRNA*COVID-19
Vaccination in VAERS – December 22, 2020 – January 31, 2023
Deaths reported in VAERS
CDC requests
medical records
Excluded
12,849 wi
th cause of death : • 1,790 re
ports of vaccine types 17,631 do
mestic VAERS 17,579 re
ports with verified death after • Autopsy: 673 othe
r than mRNA repo
rts of death following review by CDC clinician • Death certification: 8,862 • 2,940 wi
thout cause of death COVI
D-19 vaccine • Medical records: 2,576 (52 de
termined not to be a death) info
rmation available • VAER
S report alone: 738
* Includes reports with missing vaccine type, but excludes reports known to be after Janssen or Novavax COVID-19 vaccine
Reports to the Vaccine Adverse Event Reporting System (VAERS) reviewed and processed during December 22, 2020 — January 31, 2023; reported date of vaccination during December 22, 2020 — January 31, 2023 or missing 32
Safety Monitoring of Death Reports Following mRNA*COVID-19
Vaccination in VAERS – December 22, 2020 – January 31, 2023
17,631 domestic VAERS
reports of death following
COVID-19 vaccine
12,849 with cause of death :
• Autopsy: 673
• Death certification: 8,862
• Medical records: 2,576
• VAERS report alone: 738 17,579 reports with verified death after
review by CDC clinician
(52 determined not to be a death)
CDC requests
medical records
National Center for Health Statistics
Multiple Cause of Death Database
Death certificates
from U.S. residents
Cause of death categorized
by ICD-10 diagnostic codes Deaths reported in VAERS
• 1,790 reports of vaccine types
other than mRNA
• 2,940 without cause of death information available Ex
cluded
Deaths reported in general U.S. population
* Includes reports with missing vaccine type, but excludes reports known to be after Janssen or Novavax COVID-19 vaccine
Rep
orts to the Vaccine Adverse Event Reporting System (VAERS) reviewed and processed during December 22, 2020 — January 31, 2023; reported date of vaccination during December 22, 2020 — January 31, 2023 or missing 33
Safety Monitoring of Death Reports Following mRNA*COVID-19
Vaccination in VAERS – December 22, 2020 – January 31, 2023
17,631 domestic VAERS
reports of death following
COVID-19 vaccine 12,849 with cause of death :
• Autopsy: 673
• Death certification: 8,862
• Medical records: 2,576
• VAERS report alone: 738 17,579 reports with verified death after
review by CDC clinician
(52 determined not to be a death)
National Center for Health Statistics
Multiple Cause of Death Database Death certificates
from U.S. residents Cause of death categorized
by ICD-10 diagnostic codes Deaths reported in VAERS
Observed Rate
Number of deaths (cause-specific)
100,000 persons vaccinated
Within 42 days of vaccination
Expected Rate
Number of deaths (cause-specific)
100,000 persons in U.S. population
Within 42 days of vaccination • 1,790 reports of vaccine types
other than mRNA
• 2,940 without cause of death information available Exclud
ed
Deaths reported in general U.S. population
* Includes reports with missing vaccine type, but excludes reports known to be after Janssen or Novavax COVID-19 vaccine
Reports to the Vaccine Adverse Event Reporting System (VAERS) reviewed and processed during December 22, 2020 — January 31, 2023; reported date of vaccination during December 22, 2020 — January 31, 2023 or missing Abara WE, et al. Expected Rates of Select Adverse Events After Immunization for Coronavirus Disease 2019 Vaccine Safety Monitoring | The Journal of Infectious Diseases ; Mahaux O, et al. Pharmacoepidemiological considerations in observed
‐to‐expected analyses for vaccines
CDC requests
medical records
34
Reporting Rates of Death After mRNA*COVID-19 Vaccination Were Below
Background Rates of Death in the General U.S. Population
The most common causes of death reported to VAERS are consistent with the leading causes of death in the U.S. population
0 0.2 0.4 0.6 0.8 1 Observed/Expected Ratio 6 months-17 years 18-49 years 50-64 years 65+ years Observed / Expected <1: Indicates
lower observed death rate than
the expected rate within the post-
vaccination interval of 42 days
* Includes reports with missing vaccine type, but excludes reports known to be after Janssen or Novavax COVID-19 vaccine
Reports to the Vaccine Adverse Event Reporting System (VAERS) reviewed and processed during December 22, 2020 — January 31, 2023; reported date of vaccination during December 22, 2020 — January 31, 2023 or missing
Hoyert DL, Xu J. Deaths: preliminary data for 2011. Natl Vital Stat Rep. 2012; 61:1–51 ; U.S. Centers for Disease Control and Prevention. CDC WONDER. Available at https://wonder.cdc.gov/controller/datarequest/D157 Accessed March 20, 2025
Abara WE, et al. Expected Rates of Select Adverse Events After Immunization for Coronavirus Disease 2019 Vaccine Safety Monitoring | The Journal of Infectious Diseases ; Mahaux O, et al. Pharmacoepidemiological considerations in observed ‐to‐expected analyses for vaccines
National Center for Health Statistics, National Vital Statistics System. Deaths: Leading Causes of Death for 2021. 73:4. Published April 8, 2024. https://www.cdc.gov/nchs/data/nvsr/nvsr73/nvsr73-04.pdf National Center for Health Statistics, National Vital Statistics System. Deaths: Leading
Causes of Death for 2020. 72:13. Published December 5, 2023. https://www.cdc.gov/nchs/data/databriefs/db492-tables.pdf#4 35
Data From CDC’s Vaccine Safety Datalink Shows No
Increased Risk of Death Following mRNA COVID-19 Vaccines
36 0.2 0.4 0.6 0.8 1 0.2 0.4 0.6 0.8 1
0.2 0.4 0.6 0.8 1 0.2 0.4 0.6 0.8 1 Dose 1 Dose 2
Non-COVID-19 mortality
All-cause mortality Cardiac-related mortality
Non-COVID-19 cardiac-related mortality
Non-COVID-19 mortality
All-cause mortality Cardiac-related mortality
Non-COVID-19 cardiac-related mortality
Non-COVID-19 mortality
All-cause mortality Cardiac-related mortality
Non-COVID-19 cardiac-related mortality
Non-COVID-19 mortality
All-cause mortality Cardiac-related mortality
Non-COVID-19 cardiac-related mortality Pfizer-BioNTech
Moderna Ages 12 Years and Older
Ages 65 Years and Older (Medicare Beneficiaries)
Dose 1 Dose 2
X axis: Relative Incidence and 95% Confidence Intervals Pfizer-BioNTech
Moderna •2 self-controlled case series
evaluations
•No increased risk in the 28 days
after vaccination of:
-Non-COVID mortality
-All-cause mortality
-Cardiac-related mortality
-Non-COVID cardiac-related mortality
•Similar findings in VSD cohort
study of people ages 12+ years
Mortality risk after COVID-19 vaccination: A self-controlled case series study
https://pubmed.ncbi.nlm.nih.gov/38388239/
A Modified Self-Controlled Case Series on Mortality Risk following Primary Series Doses of COVID-19
Vaccines in U.S. Medicare Beneficiaries Aged 65 Years and Older - Acumen and Vaccine Safety Datalink,
unpublished pending review at journal A safety study evaluating non-COVID-19 mortality risk following COVID-19 vaccination - PubMed
Data from December 14, 2020 through August 11, 2021
Tree-based data mining for safety assessment of first COVID-19 booster doses in the Vaccine Safety Datalink – PubMed
Safety signal identification for COVID-19 bivalent booster vaccination using tree-based scan statistics in the Vaccine Safety Datalink - PubMed
37 Using Data Mining to Assess for Unexpected
Events After COVID-19 Vaccination
• >60,000 possible adverse events assessed in the
70 day
s after vaccination using tree-based data
mining of ICD-10 codes in the VSD for:
-Primary series
-Initial booster
-Bivalent booster
• No new safety concerns identified outside of
known e
vents
-E.g., myocarditis/pericarditis, allergic reactions,
common local and systemic reactions
A broad assessment of covid-19 vaccine safety using tree-based data-mining in the vaccine safety datalink - PubMed
Summary
38
38
CDC Summary: Adverse Events Associated with mRNA
COVID-19 Vaccines
Occur with any vaccines: Occur with COVID-19 vaccines:
• Local reactions • Myocarditis and pericarditis
• S
ystemic reactions
• Acute allergic reactions (e.g., anaphylaxis)
• Syncope (fainting)
• Shoulder injuries
CDC evaluated at least 65 specific safety outcomes, conducted data mining of
>60,000 potential outcomes for unexpected concerns, investigated numerous
signals, and conducted many epidemiologic studies
39
40 NASEM Consensus Report on Adverse
Effects of COVID-19 Vaccines – 2024
• Commissioned by Health Resources and Services
Administration (HRSA)
• Reviewed nearly 600 studies on safety of COVID-19 vaccines
• Concluded evidence supported causal association between mRNA COVID-19 vaccines and myocarditis
-Evidence favors rejection of causal relationship
between vaccination and 6 additional outcomes
Front Matter | Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration |
The National Academies Press
COVID-19 Vaccines Have Been Evaluated Under the Most
Extensive Safety Monitoring Program in U.S. History
• Safety surveillance identified and characterized the risk of myocarditis after mRNA
COVID-19 vaccination
• No other risks confirmed in the current U.S.-licensed vaccines except those seen with other vaccines (e.g., local and systemic reactions, allergic reactions)
• CDC continues to prioritize the monitoring of COVID-19 vaccine safety, with at least 30 ongoing studies or activities
• CDC continues to monitor the safety of COVID-19 vaccines
41