Document text
cdc.gov/coronavirusSafety update of 1stbooster mRNA
COVID -19 vaccination
Advisory Committee on Immunization Practices
(ACIP)
April 20, 2022
Nicola Klein, MD, PhD
Kaiser Permanente Vaccine Study Center
Kaiser Permanente Northern CaliforniaTom Shimabukuro, MD, MPH, MBA
Vaccine Safety TeamCDC COVID- 19 Vaccine Task Force
Safety Surveillance of 1stBooster Doses in the Vaccine
Safety Datalink
Nicola Klein, MD, PhD
Kaiser Permanente Vaccine Study Center
Kaiser Permanente Northern California
Vaccine Safety Datalink (VSD)
•Established in 1990
•Collaborative project between CDC and 9 integrated healthcare organizations
•Includes ~ 12 million individuals across all sites
3
VSD 1stBoosters by Primary Series Vaccination
Data Through April 9th, 2022
4
VSD 1stBooster Dose by Demographics
5
VSD Rapid Cycle Analysis (RCA) for Boosters
•Pre-specified surveillance outcomes were assessed during weekly
sequential monitoring after 1stCOVID- 19 booster vaccination*
‒Analyses assess the risk of pre- specified outcomes within 1– 21 days following a booster
vaccination compared with boosted individuals who are within 22– 42 days following the
booster dose, adjusting for age, sex, race/ethnicity, VSD site, time since primary series,
and calendar time.
‒Weekly sequential analyses will continue through 2022, with a one- sided p- value
threshold for signaling of 0.01.
‒Due to the association of myocarditis/pericarditis with primary mRNA vaccination, myocarditis/pericarditis cases after the 1
stbooster were also chart reviewed and
adjudicated using the CDC case definitions.
6*Rapid Cycle Analysis (RCA) to monitor the safety of COVID -19 vaccines in near real- time within the Vaccine Safety Datalink.
Available at https://www.cdc.gov/vaccinesafety/pdf/COVID19 -RCA-Protocol -1342- 508.pdf
Vaccinee with Outcome in the Risk Interval and a Concurrent Comparator
“Boosted Individuals Only”
On each calendar day that an outcome occurred
in a vaccinee (e.g., June 3), w e compared
vaccinees in their risk interval (day 1– 21) with
similar vaccinees in their comparison interval (day 22–42)
By similar, we mean they were in the same age group and of the same sex, race, and at the same VSD site
Comparison Interval 22–42 days post- vaccination 42 22 June 3
Vaccinated with Booster
May 31
Risk Interval 1–21 days post- vaccination21June 3
Vaccinated with
Booster May 30
7
Signals for Pre- specified Outcomes in 21- day Risk Interval Through 4/12/22
Primary series with Pfizer -Pfizer OR
Moderna -ModernaPfizer -
PfizerModerna -
ModernaJanssen
Signal after 1stBooster Pfizer OR Moderna Pfizer Moderna Pfizer Moderna Janssen
Outcome Event Signal?
Acute myocardial infarction No No No No No No
Appendicitis No No No No No No
Bell's palsy No No No No No No
Cerebral venous sinus thrombosis No No No - - No
Disseminated intravascular coagulation No No No No - No
Encephalitis / myelitis / encephalomyelitis No No No - - -
Guillain -Barre syndrome No No No No - No
Stroke, hemorrhagic No No No No No No
Stroke, ischemic No No No No No No
Immune thrombocytopenia No No No No No -
Myocarditis / pericarditis Yes No No No No No
Seizures No No No No No No
Transverse myelitis No No No - - -
Thrombotic thrombocytopenic purpura No No No - - No
Thrombosis with thrombocytopenia syndrome No No No - No -
Venous thromboembolism No No No No No No
Pulmonary embolism No No No No No No
8 “-” indicates that analyses are not yet possible.
VSD COVID- 19 RCA
1stBooster Dose
Myocarditis and Pericarditis –
Preliminary Chart Review Analysis
9
Myocarditis and Pericarditis: Electronic
Case Identification using ICD-10 Codes1
Code List (based on consultation with cardiologist)
•B33.22 Viral myocarditis
•B33.23 Viral pericarditis
•I30.* Acute pericarditis
•I40.* Acute myocarditis
•I51.4 Myocarditis, unspecified
•I31.9 Disease of the pericardium, unspecified
101Casedefinition excludes individuals with COVID -19 infection <30 days before
myocarditis/pericarditis diagnosis.
* Includes all subcodes.
Chart Review Summary: Myocarditis and Pericarditis
after a 1stmRNA COVID-19 Booster Vaccine
•All electronically- identified cases among all ages up to 98 days post
vaccination are being chart -reviewed.
•Chart review is completed for 271 cases through March (25 potential
cases pending).
•Adjudicators verified 139/271 (51%) myocarditis/pericarditis cases.
•12–39 years old: 53/68 (78%)
•40+ years old: 86/203 (42%)
11
Chart Review Summary: Verified Myocarditis and
Pericarditis cases after a 1stBooster Vaccine
1212–39 year olds 40+ year olds
Case verification (anytime after vaccination) 53/68 (78%) 86/203 (42%)
Male sex 38/53 (72%) 51/86 (59%)
History of COVID (>30 days prior to diagnosis) 10/53 (19%) 11/86 (13%)
History of myocarditis/pericarditis 2/53 (4%) 4/86 (5%)
Median age 25 years 68.5 years
Median time from vaccination to symptom onset 4 days 29.5 days
Adjudication diagnosis
Myocarditis 12/53 (23%) 12/86 (14%)
Pericarditis 12/53 (23%) 57/86 (66%)
Myopericarditis 29/53 (55%) 17/86 (20%)
Timing of Symptom Onset after 1stBooster: 53 Verified
Myocarditis and Pericarditis Cases in 12– 39-Year -Olds
13
Timing of Symptom Onset after 1stBooster: 86 Verified
Myocarditis and Pericarditis Cases in 40+ year -olds
14
1Comparison interval is 22– 42 days after booster dose.
2Adjusted for VSD site, 5- year age group, sex, race/ethnicity, calendar date, and time since primary series.
3“Either” includes heterologous and homologous primary -> booster doses. Product specific analyses include only homologous primar y->booster doses.
4Two additional cases were in the risk interval but were not included because there were no appropriate comparators. These cas es are included in the events/million dose calculation.Analysis
Ages VaccineEvents
inRisk
IntervalEvents in
Comparison
Interval1Adjusted
Rate Ratio295%
Confidence
Interval2-Sided
P-valueEvents/Million
Doses
1st
Booster312–39 Either 28 10 4.89 2.24 –11.31 <0.001 20.3 (13.5 –29.3)
12–39 Pfizer 18 6 5.14 1.86 –15.90 0.001 21.4 (12.7 –33.8)
12–39 Moderna45 3 3.64 0.79 –19.45 0.097 17.0 (6.8 –35.0)Verified Myocarditis and Pericarditis in the 0–7 Day Risk Interval
Compared with Events on the Same Calendar Days Among Primary Series and Boosted Comparators
15
1Comparison interval is 22– 42 days after booster dose.
2Adjusted for VSD site, 5- year age group, sex, race/ethnicity, calendar date, and time since primary series.
3“Either” includes heterologous and homologous primary -> booster doses. Product specific analyses include only homologous primar y-> booster doses.
4Two additional cases were in the risk interval but were not included because there were no appropriate comparators. These cas es are included in the events/million dose calculation.
5One additional case was in the risk interval but not included because there were no appropriate comparators. This case is inc luded in the events/million dose calculation.Analysis
Ages VaccineEvents in Risk
IntervalEvents in
Comparison
Interval1Adjusted
Rate Ratio295%
Confidence
Interval2-Sided
P-valueEvents/Million
Doses
Primary,
Dose 212–39 Either 112 14 24.38 14.00 –44.96 <0.001 38.2 (31.5 –45.9)
12–39 Pfizer 83 10 28.07 14.63 –58.50 <0.001 41.4 (33.1 –51.1)
12–39 Moderna 28 3 24.49 7.82 –105.14 <0.001 30.8 (20.5 –44.5)
1st
Booster312–39 Either 28 10 4.89 2.24 –11.31 <0.001 20.3 (13.5 –29.3)
12–39 Pfizer 18 6 5.14 1.86 –15.90 0.001 21.4 (12.7 –33.8)
12–39 Moderna45 3 3.64 0.79 –19.45 0.097 17.0 (6.8 –35.0)Verified Myocarditis and Pericarditis in the 0–7 Day Risk Interval
Compared with Events on the Same Calendar Days Among Primary Series and Boosted Comparators
16
1Comparison interval is 22– 42 days after booster dose.
2Adjusted for VSD site, 5- year age group, sex, race/ethnicity, calendar date, and time since primary series.
3“Either” includes heterologous and homologous primary -> booster doses. Product specific analyses include only homologous primar y->booster doses.
4Two additional cases were in the risk interval but were not included because there were no appropriate comparators. These cas es are included in the events/million dose calculation.
5One additional case was in the risk interval but not included because there were no appropriate comparators. This case is inc luded in the events/million dose calculation.Analysis
Ages VaccineEvents
inRisk
IntervalEvents in
Comparison
Interval1Adjusted
Rate Ratio295%
Confidence
Interval2-Sided
P-valueEvents/Million
Doses
1st
Booster312–39 Either 28 10 4.89 2.24 –11.31 <0.001 20.3 (13.5 –29.3)
12–39 Pfizer 18 6 5.14 1.86 –15.90 0.001 21.4 (12.7 –33.8)
12–39 Moderna45 3 3.64 0.79 –19.45 0.097 17.0 (6.8 –35.0)
40+ Either511 15 2.30 0.95 –5.43 0.063 4.0 (2.1 –7.0)
40+ Pfizer54 5 1.65 0.34 –7.31 0.509 3.3 (1.1 –7.6)
40+ Moderna44 8 1.85 0.43 –6.85 0.373 4.6 (1.7 –10.1)
17Verified Myocarditis and Pericarditis in the 0–7 Day Risk Interval
Compared with Events on the Same Calendar Days Among Primary Series and Boosted Comparators
1Comparison interval is 22– 42 days after booster dose.
2Adjusted for VSD site, 5- year age group, sex, race/ethnicity, calendar date, and time since primary series.
3“Either” includes heterologous and homologous primary -> booster doses. Product specific analyses include only homologous primar y-> booster doses.
4Two additional cases were in the risk interval but were not included because there were no appropriate comparators. These cas es are included in the events/million dose calculation.Analysis
Ages VaccineEvents
inRisk
IntervalEvents in
Comparison
Interval1Adjusted
Rate Ratio295%
Confidence
Interval2-Sided
P-valueEvents/Million
Doses
1st
Booster312–39 Either 30 10 1.90 0.91 –4.25 0.092 21.9 (14.8 –31.2)
12–39 Pfizer 19 6 2.07 0.79 –6.05 0.146 22.8 (13.7 –35.6)
12–39 Moderna46 3 1.36 0.33 –6.87 0.697 19.5 (8.4 –38.5)Verified Myocarditis and Pericarditis in the 0–21 Day Risk Interval
Compared with Events on the Same Calendar Days Among Primary Series and Boosted Comparators
18
1Comparison interval is 22– 42 days after booster dose.
2Adjusted for VSD site, 5- year age group, sex, race/ethnicity, calendar date, and time since primary series.
3“Either” includes heterologous and homologous primary -> booster doses. Product specific analyses include only homologous primar y-> booster doses.
4Two additional cases were in the risk interval but were not included because there were no appropriate comparators. These cas es are included in the events/million dose calculation.
5Four additional cases were in the risk interval but not included because there were no appropriate comparators. These cases are included in the events/million dose calculation.
6Three additional cases were in the risk interval but not included because there were no appropriate comparators. These cases areincluded in the events/million dose calculation.Analysis
Ages VaccineEvents
inRisk
IntervalEvents in
Comparison
Interval1Adjusted
Rate Ratio295%
Confidence
Interval2-Sided
P-valueEvents/Million
Doses
1st
Booster312–39 Either 30 10 1.90 0.91 –4.25 0.092 21.9 (14.8 –31.2)
12–39 Pfizer 19 6 2.07 0.79 –6.05 0.146 22.8 (13.7 –35.6)
12–39 Moderna46 3 1.36 0.33 –6.87 0.697 19.5 (8.4 –38.5)
40+ Either529 15 1.96 1.02 –3.88 0.044 11.0 (7.5 –15.4)
40+ Pfizer515 5 3.01 1.06 –9.68 0.038 12.5 (7.5 –19.5)
40+ Moderna69 8 1.28 0.42 –3.80 0.650 9.3 (4.8 –16.3)Verified Myocarditis and Pericarditis in the 0–21 Day Risk Interval
Compared with Events on the Same Calendar Days Among Primary Series and Boosted Comparators
19
Summary: Preliminary Findings of RCA Monitoring for 1st
Boosters
•In weekly surveillance, the only safety signal has been for myocarditis/pericarditis
in the 21 days after a 1stbooster dose.
•No other safety signals in weekly monitoring of pre- specified outcomes.
•Myocarditis/pericarditis differed between persons ages 12– 39 and 40+ years.
•12–39 years: mostly myocarditis and myopericarditis with onset <7 days after 1stbooster.
•40+ years: mostly pericarditis; cases more spread out in the 3 weeks after 1stbooster.
•For persons ages 12– 39 years, rate ratios for myocarditis/pericarditis 0– 7 days
after 1stbooster dose were elevated.
•Rate per million 1stbooster doses administered was not higher than after primary series dose
2 mRNA COVID -19 vaccination.
•For persons ages 40 years and older, rate ratios for myocarditis/pericarditis were elevated, but less so, in the 0– 7 and 0– 21 days after the 1
stbooster dose
compared with persons ages 12– 39 years.
•Surveillance is ongoing.
20
cdc.gov/coronavirusSafety update of 1stbooster mRNA
COVID -19 vaccination
Vaccine Adverse Event Reporting System (VAERS)
&
V-safe
Tom Shimabukuro, MD, MPH, MBA
Vaccine Safety Team
CDC COVID- 19 Vaccine Task Force
+co-managed by
CDC and FDA
Vaccine Adverse Event
Reporting System
http://vaers.hhs.govVAERS is the nation’s early warning system for vaccine safety
22
VAERS accepts reports from everyone
Key strengths
Rapidly detects potential
safety problems
Can detect rare adverse
eventsKey limitations
Passive surveillance system
Inconsistent quality and completeness of information
Reporting biases
Generally, cannot determine cause and effectRegardless of the plausibility of the vaccine causing the event or the
clinical seriousness of the event
23
U.S. reports to VAERS following 1stbooster mRNA COVID- 19
vaccination* (as of April 11, 2022)
24* Among persons receiving Pfizer -BioNTech dose 3: children and adolescents ages 12– 15 years vaccinated during Jan 3 – April 11, 2022, and ages 16– 17 years vaccinated during Dec 9, 2021 –
April 11, 2022; adults ages ≥18 years vaccinated during September 22, 2021 –April 11, 2022. Among persons receiving Moderna boo ster doses, adults ages ≥18 years vaccinated during October
20, 2021 –April 11, 2022. All reports received and processed as of April 11, 2022.
†Doses of Pfizer -BioNTech dose 3 administered among children and adolescents ages 12 –15 years during January 6 –Apr 14, 2022; a dolescents ages 16– 17 years during Dec 9, 2021 –April 14,
2022; adults ages ≥18 years during September 22, 2021 –April 14, 2022. Doses of Moderna dose 3 administered among adults ages ≥ 18 years during October 28, 2021 –April 14, 2022
‡ Sex was not reported in approximately 2% of reports.Proportions by seriousness and sex were comparable to primary series
•Most reports (90%) were non- serious
•Most reports (65%) were among femalesDoses
admin†Total
reportsMedian
ageMale‡
n (%)Female‡
n (%)Non -serious
n (%)Serious
n (%)
93,118,318 52,063 53 years 17,281 (33) 33,692 (65) 47,014 (90) 5,049 (10)
U.S. reports to VAERS following 1st
booster mRNA COVID -19 vaccination,
by race and ethnicity * (as of April 11, 2021) Race and ethnicity n (%)
Non -Hispanic White 25,508 (49)
Unknown or not reported 14,787 (28)
Hispanic† 3,616 (7)
Non -Hispanic Other 2,987 (6)
Non -Hispanic Black 2,264 (4)
Non -Hispanic Asian 1,764 (3)
Non -Hispanic multiracial 561 (1)
Non -Hispanic American
Indian/Alaskan Native520 (<1)
Non -Hispanic Native Hawaiian
or Other Pacific Islander56 (<1)
Total 52,063* Among persons receiving Pfizer -BioNTech dose 3: children and adolescents ages 12 –15 years
vaccinated during Jan 3 –April 11, 2022, and ages 16 –17 years vaccinated during Dec 9, 2021 –
April 11, 2022; adults ages ≥18 years vaccinated during September 22, 2021 –April 11, 2022.
Among persons receiving Moderna booster doses, adults ages ≥18 years vaccinated during October
20, 2021 – April 11, 2022. All reports received and processed as of April 11, 2022.
†Includes persons reported as of Hispanic ethnicity, but of unreported or unknown race.
25
Most frequently reported non- serious adverse events to VAERS following 1stbooster
mRNA COVID -19 vaccination (47,014 total non- serious reports) * (as of April 11, 2022)
26Rank Adverse event (not mutually exclusive) n (%)
1 Headache 6,119 (13)
2 Pyrexia 5,840 (12)
3 Pain 5,783 (12)
4 Fatigue 5,420 (12)
5 Expired Product Administered 5,082 (11)
6 Chills 4,836 (10)
7 Product Storage Error 4,030 (9)
8 Pain In Extremity 3,813 (8)
9 Nausea 3,209 (7)
10 Dizziness 2,982 (6)Non-serious reports (all reports) Non-serious reports (clinical outcomes)†
Rank Adverse event (not mutually exclusive) n (%)
1 Headache 6,119 (13)
2 Pyrexia 5,840 (12)
3 Pain 5,783 (12)
4 Fatigue 5,420 (12)
5 Chills 4,836 (10)
6 Pain In Extremity 3,813 (8)
7 Nausea 3,209 (7)
8 Dizziness 2,982 (6)
9 Urticaria 2,966 (6)
10 Lymphadenopathy 2,896 (6)
* Among persons receiving Pfizer -BioNTech dose 3: children and adolescents ages 12 –15 years vaccinated during Jan 3 – April 11, 2022, and ages 16 –17 years vaccinated during Dec 9,
2021 –April 11, 2022; adults ages ≥18 years vaccinated during September 22, 2021 –April 11, 2022. Among persons receiving Mode rna booster doses, adults ages ≥18 years vaccinated
during October 20, 2021 – April 11, 2022. All reports received and processed as of April 11, 2022.
† Determined by subject matter expert consensus
Most frequently reported serious adverse events to VAERS following 1stbooster
mRNA COVID -19 vaccination (5,049 total serious reports) (as of April 11, 2022)
27Rank Adverse event (not mutually exclusive) n (%)
1 Covid -19 1,196 (24)
2 Sars-Cov-2 Test Positive 997 (20)
3 Dyspnoea 817 (16)
4 Death 549 (11)
5 Chest Pain 440 (9)
6 Pyrexia 436 (9)
7 Asthenia 435 (9)
8 Condition Aggravated 396 (8)
9 Fatigue 386 (8)
10 Pain 369 (7)Serious reports (all reports) Serious reports (clinical outcomes)†
Rank Adverse event (not mutually exclusive) n (%)
1 Covid -19 1,196 (24)
2 Sars-Cov-2 Test Positive 997 (20)
3 Dyspnoea 817 (16)
4 Death 549 (11)
5 Chest Pain 440 (9)
6 Pyrexia 436 (9)
7 Asthenia 435 (9)
8 Fatigue 386 (8)
9 Pain 369 (7)
10 Cough 328 (7)
* Among persons receiving Pfizer -BioNTech dose 3: children and adolescents ages 12 –15 years vaccinated during Jan 3 – April 11, 2022, and ages 16 –17 years vaccinated during Dec 9,
2021 –April 11, 2022; adults ages ≥18 years vaccinated during September 22, 2021 –April 11, 2022. Among persons receiving Mode rna booster doses, adults ages ≥18 years vaccinated
during October 20, 2021 – April 11, 2022. All reports received and processed as of April 11, 2022.
† Determined by subject matter expert consensus
28Median age in myocarditis case reports is younger vs. pericarditis
Male predominance observed for myocarditis case reports but not for pericarditisMyocarditis (n=110) Pericarditis (n=38)
Median age (IQR†) 23 (16– 36) 46 (25– 62)
Median time to symptom onset (IQR†) 3 (2– 4) 3 (1– 7)
Male, n (%) / Female, n (%) 89 (81%) / 21 (19%) 18 (47%) / 20 (53%)U.S. reports to VAERS of myocarditis and pericarditis following 1stbooster
mRNA COVID -19 vaccination, by age, time to symptom onset, and sex*
(as of April 11, 2022)
* Among persons receiving Pfizer -BioNTech dose 3: children and adolescents ages 12 –15 years vaccinated during Jan 3 – April 11, 2022, and ages 16 –17 years vaccinated during Dec 9,
2021 –April 11, 2022; adults ages ≥18 years vaccinated during September 22, 2021 –April 11, 2022. Among persons receiving Mode rna booster doses, adults ages ≥18 years vaccinated
during October 20, 2021 – April 11, 2022. All reports received and processed as of April 11, 2022.
†Interquartile range.
29Most myocarditis
reports among ages 12–29 years
Pericarditis reports distributed fairly evenly among age groups*
024681012141618
12 to 15 16 to 17 18 to 24 25 to 29 30 to 39 40 to 49 50 to 64 65+Verified reports to VAERS
Age group, yearsMyocarditis or pericarditis following 1stmRNA COVID -19 booster
vaccination among males , days 0– 7, by age group, VAERS
Pfizer, myocarditis Moderna, myocarditis Pfizer, pericarditis Moderna, pericarditis
* Complicates estimation of reporting rates
024681012141618
12 to 15 16 to 17 18 to 24 25 to 29 30 to 39 40 to 49 50 to 64 65+Verified reports to VAERS
Age group, yearsMyocarditis or pericarditis following 1stmRNA COVID -19 booster
vaccination among males , days 0– 7, by age group, VAERS
Pfizer, myocarditis Moderna, myocarditis Pfizer, pericarditis Moderna, pericarditis
30Most myocarditis
reports among ages 12–29 years
Pericarditis reports distributed fairly evenly among age groups*
* Complicates estimation of reporting rates
31Most myocarditis
reports among ages 12–29 years
Pericarditis reports distributed fairly evenly among age groups*
* Complicates estimation of reporting rates024681012141618
12 to 15 16 to 17 18 to 24 25 to 29 30 to 39 40 to 49 50 to 64 65+Verified reports to VAERS
Age group, yearsMyocarditis or pericarditis following 1stmRNA COVID -19 booster
vaccination among males , days 0– 7, by age group, VAERS
Pfizer, myocarditis Moderna, myocarditis Pfizer, pericarditis Moderna, pericarditis
32Few reports among
females of either condition
Both myocarditis and pericarditis reports distributed fairly evenly among age groups
024681012141618
12 to 15 16 to 17 18 to 24 25 to 29 30 to 39 40 to 49 50 to 64 65+Verified reports to VAERS
Age group, yearsMyocarditis or pericarditis following 1stmRNA COVID -19 booster
vaccination among females , days 0– 7, by age group, VAERS
Pfizer, myocarditis Moderna, myocarditis Pfizer, pericarditis Moderna, pericarditis
Reporting rates of myocarditis (per 1 million doses administered) among
males following 1stmRNA COVID -19 booster vaccination, by risk interval*
41,670,922 1stmRNA COVID -
19 booster vaccinations
administered in males*
Reporting rates exceed background incidence in ages 12 –29 years
Reporting rates highest in males ages 16 –17 years,
followed by 12– 15 years
* Among persons receiving Pfizer -BioNTech dose 3: children and adolescents ages 12 –15 years vaccinated during Jan 3 – April 11, 2022, and ages 16 –17 years vaccinated during Dec 9,
2021 –April 11, 2022; adults ages ≥18 years vaccinated during September 22, 2021 –April 11, 2022. Among persons receiving Mode rna booster doses, adults ages ≥18 years
vaccinated during October 20, 2021 – April 11, 2022. All reports received and processed as of April 11, 2022. Doses administered as of April 14, 2022. An estimated 1 –10 cases of
myocarditis per 100,000 person years occurs among people in the United States, regardless of vaccination status; adjusted for day 0–7 and 0 –21 risk periods, this estimated
background is 0.2 to 2.2 per 1 million person risk period. 33Pfizer -BioNTech Moderna
age group Days 0 –7 Days 0 –7
12 to 15 17.2 N/A
16 to 17 23.2 N/A
18 to 24 5.4 12.1
25 to 29 4.8 4.0
30 to 39 1.5 1.5
40 to 49 0.0 <1.0
50 to 64 <1.0 0.0
65+ <1.0 <1.0
Clinical outcomes of myocarditis and pericarditis following 1stmRNA
COVID -19 booster vaccination*
93,118,318 total
booster doses
administered*
Patients not
hospitalized
received outpatient
care
Patients still recovering are
stable or improving
34* Doses of Pfizer -BioNTech dose 3 administered among children and adolescents ages 12 –15 years during January 6 –Apr 14, 2022; adolescents ages 16 –17 years during Dec 9,
2021 –April 14, 2022; adults ages ≥18 years during September 22, 2021 –April 14, 2022. Doses of Moderna dose 3 administered am ong adults ages ≥18 years during October 28,
2021 –April 14, 2022 Myocarditis
(N=110)Pericarditis
(N=38)
Hospitalized 90/110 (82%) 15/38 (39%)
Discharged 90/90 (100%) 15/15 (100%)
Known outcomes 86/90 (96%) 14/15 (93%)
Recovered from symptoms at
last follow up51/86 (59%) 10/14 (71%)
35Smartphone -based active safety monitoring
http:// cdc.gov/vsafe
Enroll yourself or
your dependent
after any dose!
Active safety monitoring for COVID -19 vaccines
v-safe is a CDC smart phone -based monitoring program for COVID- 19
vaccine safety in the U.S.
•Uses text messaging and web surveys to check in with vaccine recipients after
vaccination
•Can register at any time: after first, second, or third dose
•Solicits participants' reports on how they feel after COVID -19 vaccination
‒Local injection site reactions (i.e., pain, redness, swelling)
‒Systemic reactions (i.e., fatigue, headache, joint pain)
‒Health impacts (unable to perform normal daily activities, missed school or work, or received care)
36
Patterns of vaccination for 729,720 v -safe participants aged
≥18 years who reported a booster dose
Moderna (%) Pfizer -BioNTech (%) Janssen (%) Total
Moderna 311,374 (94) 17,034 23,211 351,619
Pfizer -BioNTech 19,538 336,618 (95) 13,685 369,841
Janssen 247 238 7,775 (17) 8,260
Total 331,159 353,890 44,671 729,720Primary series
Booster
dose
Data as of April 10, 2022. Includes participants who completed at least one survey in the first week after each dose (administered beginning
September 22, 2021 for Pfizer -BioNTech and October 20,2021 for Moderna and Janssen). 37
Demographic summary of 729,720 v -safe participants aged
≥18 years who reported a booster dose
Data as of April 10, 2022. Includes participants who completed at least one survey in the first week after each dose (administered beginning
September 22, 2021 for Pfizer -BioNTech and October 20,2021 for Moderna and Janssen).
Abbreviations: AI/AN = American Indian/Alaska Native; NHPI = Native Hawaiian or other Pacific Islander; AA=African American.Characteristic % of participants
Sex
Female 62.8
Male 36.4
Unknown 0.8
Age group (years)
18–49 268,632
50–64 189,735
65–74 210,566
75–84 56,051
≥85 4,736Characteristic % of participants
Ethnicity
Hispanic or Latino 6.7
Not Hispanic/ Latino 90.2
Unknown 3.1
Race
AI/AN 0.4
Asian 5.4
Black or AA 5.6
NHPI 0.2
White 82.9
Multiracial 1.8
Other 1.9
Unknown 1.8
38
Reactions and health impact events reported by v -safe participants aged ≥18 years at
least once in days 0– 7 after homologous Pfizer -BioNTech vaccination, by dose
Includes 336,618 participants who completed at least one survey in the first week after each dose, data collected during Sept emb er 22 –April 10, 2022
* Dose 2 compared to dose 3: statistically significant difference (p -value <0.05) using multivariable generalized estimating equ ations model that accounted for
the correlation between registrants and adjusted for demographic variables. 390102030405060708090100
Any injection site
reactionAny systemic reaction Any health impact Unable to perform
daily activitiesUnable to work Needed medical carePercentage
Dose 1 Dose 2 Booster* *
**
*
*
Reactions and health impact events reported by v -safe participants aged 12– 17 years
at least once in days 0– 7 after homologous Pfizer -BioNTech vaccination, by dose
Includes 3,694 participants who completed at least one survey in the first week after each dose, data collected during December 9, 2021– April 10, 2022
* Dose 2 compared to dose 3: statistically significant difference (p -value <0.05) using multivariable generalized estimating equ ations model that accounted for
the correlation between registrants and adjusted for demographic variables. 400102030405060708090100
Any injection site
reactionAny systemic reaction Any health impact Unable to perform
daily activitiesUnable to work or
attend schoolNeeded medical carePercentage
Dose 1 Dose 2 Booster*
*
*
*
*
Reactions and health impact events reported by v -safe participants aged ≥18 years at
least once in days 0– 7 after homologous Moderna vaccination, by dose
Includes 311,374 participants who completed at least one survey in the first week after each dose, data collected during Octo ber20–April 10, 2022
* Dose 2 compared to dose 3: statistically significant difference (p -value <0.05) using multivariable generalized estimating equ ations model that accounted for
the correlation between registrants and adjusted for demographic variables. 410102030405060708090100
Any injection site
reactionAny systemic reaction Any health impact Unable to perform
daily activitiesUnable to work Needed medical carePercentage
Dose 1 Dose 2 Booster**
*
**
Summary of the safety of 1stbooster
mRNA COVID -19 vaccination
42
Summary
VSD Rapid Cycle Analysis (RCA) monitoring
The only safety signal detected for any pre -specified outcome following 1stbooster dose has
been for myocarditis/pericarditis in the 21 days after mRNA COVID- 19 vaccination
Myocarditis/pericarditis differed between persons ages 12 –39 and 40+ years
•12–39 years: mostly myocarditis and myopericarditis with onset <7 days after vaccination
•40+ years: mostly pericarditis; cases more spread out in the 3 weeks after vaccination
For persons ages 12 –39 years, rate ratios for myocarditis/pericarditis 0 –7 days after 1st
booster dose were elevated
•Rate per million 1stbooster doses administered was not higher than after dose 2 mRNA
COVID -19 vaccination
For persons ages 40 years and older, rate ratios for myocarditis/pericarditis were elevated,
but less so in the 0 –7 and 0– 21 days after the 1stbooster dose compared to persons ages 12 –
39 years
43
Summary (cont.)
VAERS monitoring (after 93 million 1stmRNA COVID -19 booster vaccinations in the United Sates)
Local and systemic reactions are most commonly reported following 1stbooster dose
110 verified reports of myocarditis and 38 of pericarditis
•Myocarditis reporting rates were highest among young males (ages 12– 29 years)
‒Reporting rates for persons ages 12 –29 years following 1stbooster exceeded
background, but were lower compared to post -dose 2 rates with primary series
•Pericarditis reports were relatively rare, and distributed evenly among males and
females and among the varied age groups
•More myocarditis (82%) than pericarditis (39%) case patients were hospitalized
‒Most hospitalized patients recovered from symptoms at time of follow up*
V-safe monitoring
No unusual or unexpected findings or new safety concerns identified
44 *Follow up varies based on timing of the report and healthcare records availability
Summary (cont.)
45Active surveillance in VSD and passive surveillance in VAERS suggests an increased risk of
myocarditis/pericarditis following the 1stmRNA COVID- 19 booster vaccination
•For myocarditis, the findings are consistent with those observed with primary series vaccination, but the risk appears to be lower following the 1
stbooster dose compared
to dose 2 of primary series
‒Risk of myocarditis is highest in younger males with onset clustering within 0 –7
days of 1stbooster vaccination
‒Pericarditis is less common, more evenly distributed between males and females, and more evenly distributed across age groups
Local and systemic reactogenicity and health impacts appear similar or attenuated for 1st
mRNA COVID- 19 booster vaccination compared to dose 2 of primary series
Monitoring is ongoing
Acknowledgments
VAERS team
CISA team
VSD team
COVID -19 Vaccine Task Force Data Monitoring
and Reporting Group
CDC Immunization Safety Office
FDA/Center for Biologics Evaluation and Research
State and local health departments
Healthcare providers and other stakeholders
reporting to VAERS
V-safe team
V-safe participants
Anne Hause
James Baggs
Paige Marquez
Isaac McCullum
Bicheng Zhang
Tanya Myers
46Kaiser Permanente Northern California
•Nicky Klein, Laurie Aukes, Berwick Chan, Bruce Fireman, Kristin Goddard, Ned Lewis, Karen Nunley, Pat Ross, Arnold
Yee, Ousseny Zerbo, Nandini Bahkshi
Marshfield Clinic Research Institute
•Jim Donahue, Ed Belongia, Tom Boyce, Kayla Hanson, Burney Kieke, Dave McClure, Erica Scotty
CDC Immunization Safety Office
•Eric Weintraub, Tat’Yana Kenigsberg, Mike McNeil, Jonathan Duffy, Frank Destefano, Tanya Myers, Tom
Shimabukuro, Matt Oster
VSD Sites
•HealthPartners Institute, Minneapolis, Minnesota
•Kaiser Permanente Colorado, Denver, Colorado
•Kaiser Permanente Northwest, Portland, Oregon
•Kaiser Permanente Southern California, Los Angeles,
California
•Kaiser Permanente Washington, Seattle, Washington
•Denver Health, Denver, Colorado
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!