COVID-19 vaccine safety update: Primaryseries in young children and booster doses
in older children and adults
Advisory Committee on Immunization Practices(ACIP)
September 1, 2022

Tom Shimabukuro, MD, MPH, MBA
CDC COVID-19 Immunization Safety Unit

cdc.gov/coronavirus

Topics▪ Background on CDC vaccine safety monitoring systems▪ Safety of primary series mRNA COVID-19 vaccination inchildren ages 6 months–5 years▪ Safety of mRNA COVID-19 booster vaccinations in people ages
5 years and older▪ Summary

2

VAERS is the nation’s early warning system for vaccine safety+

Vaccine Adverse Event
Reporting System

http://vaers.hhs.gov

3

VAERS
VAERS accepts reports from everyone (healthcare professionals, patients,
parents, caregivers, manufacturers, etc.) regardless of the plausibility ofthe vaccine causing the event or the clinical seriousness of the event

Key strengths

Key limitations▪ Rapidly detects potential
safety problems▪ Passive surveillance system▪ Can detect rare adverse
events▪ Inconsistent quality andcompleteness of information▪ Reporting biases▪ Generally, cannot determine
cause and effect4

Smartphone-based active safety monitoring
Enroll yourself or
your dependent
after any dose!

https://vsafe.cdc.gov

5

Active safety monitoring for COVID-19 vaccines
V-safe is a voluntary CDC smart phone-based monitoring programfor COVID-19 vaccine safety in the United States▪ Uses text messaging and web surveys to check in with vaccine recipients
after vaccination▪ Solicits participants’ reports on how they feel after COVID-19 vaccination• Local injection site reactions (e.g., pain, redness, swelling)• Systemic reactions (e.g., fatigue, headache, joint pain)• Health impacts (unable to perform normal daily activities, missed
school or work, or received care)▪ Parents can register and complete surveys on behalf of their child6

Vaccine Safety Datalink (VSD)▪ Established in 1990
▪ Collaborative project between CDC and 9 integrated healthcare organizations
7

VSD Rapid Cycle Analysis (RCA)
Aims▪ To monitor the safety of COVID-19 vaccines weekly using pre-specified
outcomes of interest among VSD members▪ To describe the uptake of COVID-19 vaccines over time among eligible VSD
members overall and in strata by age, site, and race/ethnicity

8

mRNA COVID-19 vaccine safety of primary series
vaccination in children ages 6 months–5 years

9U.S. reports to VAERS among children after primary series Pfizer-BioNTech (ages 6
months–4 years) or Moderna (ages 6 months–5 years) vaccination* (as of August 21, 2022)

Doses
Manufacturer admin†

Total
reports

Median
age

Male‡
n (%)

Female‡n (%)

Nonseriousn (%)

Serious§n (%)

Myocarditis
reports (n)PfizerBioNTech

890,378496

3 years

249 (50)245 (49)486 (98)

10 (2)

0Moderna

664,484521

2 years272 (52)240 (46)512 (98)

9 (2)

0

Total

1,554,862

1,017

3 years

521 (51)

485 (48)998 (98)

19 (2)

0* Among children ages 6 months–4 years after Pfizer-BioNTech, and among children ages 6 months–5 years after Moderna, vaccinated during June 18–August 21,
2022; reports received and processed as of August 23, 2022
† Dose 1 and dose 2 administered among children described in previous footnote during June 16–August 18, 2022.
‡ 2 reports after Pfizer-BioNTech and 9 reports after Moderna did not have sex reported§ Based on the Code of Federal Regulations if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization,
permanent disability, congenital anomaly or birth defect10

Most frequent MedDRA Preferred Terms* in reports to VAERS following primary series
Pfizer-BioNTech vaccination in children ages 6 months–4 years† (as of August 21, 2022)
N=496, clinical outcomes only shown‡

N=496, all reports
Rank

MedDRA PT (not mutually exclusive)

n (%)

Rank

MedDRA PT (not mutually exclusive)

n (%)

1

Incorrect Dose Administered

87 (18)1

Pyrexia/fever

84 (17)2

Pyrexia/fever

84 (17)2Rash

52 (11)

3

Product Administered to Patient of
Inappropriate Age

55 (11)

3

Vomiting

39 (8)

4

No Adverse Event

54 (11)

4

Fatigue30 (6)5Rash

52 (11)

5

Urticaria

23 (5)

6

Product Preparation Issue

50 (10)6

COVID-19

19 (4)

7

Vomiting

39 (8)

7

Diarrhoea

19 (4)

8

Wrong Product Administered

34 (7)8

SARS-CoV-2 Test Positive

18 (4)

9

Fatigue30 (6)

9Cough

17 (3)10

SARS-CoV-2 Test Negative

24 (5)

10

Decreased Appetite

17 (3)* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)† Among children ages 6 months–4 years vaccinated during June 18–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review

11Most frequent MedDRA Preferred Terms* in reports to VAERS following primaryseries Moderna vaccination in children ages 6 months–5 years† (as of August 21, 2022)
N=521, clinical outcomes only shown‡

N=521, all reports
Rank

MedDRA PT (not mutually exclusive)

n (%)

Rank

MedDRA PT (not mutually exclusive)

n (%)

1

Pyrexia/Fever

115 (22)1

Pyrexia/Fever

115 (22)2Rash

45 (9)2Rash

45 (9)

3

Vomiting

45 (9)

3

Vomiting

45 (9)

4

Urticaria

43 (8)

4

Urticaria

43 (8)

5

No Adverse Event

42 (8)

5Cough

35 (7)

6

Expired Product Administered

36 (7)

6

Irritability

33 (6)

7Cough

35 (7)

7

Fatigue31 (6)

8

Incorrect Dose Administered35 (7)

8

Decreased Appetite

30 (6)9

SARS-CoV-2 Test Negative

35 (7)

9

Rash Erythematous

28 (5)

10

Irritability

33 (6)

10

Diarrhoea

27 (5)* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)† Among children ages 6 months–5 years vaccinated during June 18–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review

12V-safe enrollment among children ages 6 months–≤4 years (PfizerBioNTech) and 6 months–≤5 years (Moderna)

Primary series doses
administerednationally*

V-safeenrollment

Moderna in children ≤5 years

664,484

14,725 children

Pfizer-BioNTech in children ≤4 years

890,378

8,541 children

Vaccine and age group

Data as of August 21, 2022
* Dose 1 and dose 2 administered among children described in previous footnote during June 16–August 18, 2022.

13

Reactions and health impacts reported for children aged 6 months–≤2
years at least once in days 0–7 following COVID-19 vaccination, by doseModernaN = 8,338

100

90

90

80

80

70

70

Percentage

Percentage

100

60

50
40

60

50
40

30

30

20

20

10

10

0

0

Any injection site
reaction

Any systemic reaction Any health impact

Dose 1

Dose 2

Pfizer-BioNTech
N = 4,749

Any injection site
reaction

Any systemic
reaction

Dose 1

Any health impact

Dose 2

Data as of August 21, 2022. Includes 4,749 children (aged 6 months–2 years) who received Pfizer-BioNTech and 8,338 who received Moderna.

14

Reactions and health impacts reported for children aged 3–5 years atleast once in days 0–7 following COVID-19 vaccination, by doseModernaN = 6,387

100

90

90

80

80

70

70

Percentage

Percentage

100

60

50
40

60

50
40

30

30

20

20

10

10

0

0

Any injection site
reaction

Any systemic reaction Any health impact

Dose 1

Dose 2

Pfizer-BioNTech
N = 3,792

Any injection site
reaction

Any systemic
reaction

Dose 1

Any health impact

Dose 2

Data as of August 21, 2022. Includes 3,792 children (aged 3–4 years) who received Pfizer-BioNTech and 6,387 who received Moderna (aged 3–5 years) .

15

VSD COVID-19 vaccine RCA prespecified surveillance outcomes
Prespecified outcomes

EHR = Electronic
health record

Settings

Acute disseminated encephalomyelitis

Emergency dept, Inpatient

Acute myocardial infarction – First ever in EHR in ICD-10 era

Emergency dept, Inpatient

Acute respiratory distress syndrome

Emergency dept, Inpatient

Anaphylaxis – First in 7 days in EHR in ICD-10 era

Emergency dept, Inpatient

Appendicitis

Emergency dept, Inpatient

Bell’s palsy – First ever in EHR in ICD-10 era

Emergency dept, Inpatient, Outpatient

Cerebral venous sinus thrombosis

Emergency dept, Inpatient

Disseminated intravascular coagulation

Emergency dept, Inpatient

Encephalitis / myelitis / encephalomyelitis

Emergency dept, Inpatient

Guillain-Barré syndrome

Emergency dept, Inpatient

Immune thrombocytopenia

Emergency dept, Inpatient, Outpatient

Kawasaki disease

Emergency dept, Inpatient

Multisystem inflammatory syndrome in children/adults (MIS-C/MIS-A)

Emergency dept, Inpatient

Myocarditis / pericarditis – First in 60 days in EHR in ICD-10 era

Emergency dept, Inpatient

Narcolepsy / cataplexy

Emergency dept, Inpatient, Outpatient

Pulmonary embolism – First ever in EHR in ICD-10 era

Emergency dept, Inpatient

Seizures (including 0-7 days for youngest ages)

Emergency dept, Inpatient

Stroke, hemorrhagic

Emergency dept, Inpatient

Stroke, ischemic

Emergency dept, Inpatient

Thrombosis with thrombocytopenia syndrome – First ever in EHR in ICD-10 era

Emergency dept, Inpatient

Thrombotic thrombocytopenic purpura

Emergency dept, Inpatient

Transverse myelitis

Emergency dept, Inpatient

Venous thromboembolism – First ever in EHR in ICD-10 era

Emergency dept, Inpatient, Outpatient

16

VSD RCA results in children ages 6 months–4 years (Pfizer-BioNTech) and 6
months–5 years (Moderna) for primary series mRNA COVID-19 vaccination▪ Doses administered:

Doses

PfizerBioNTech

Moderna

Total

Dose 1

31,784

34,466

66,250

Dose 2

18,72917,94036,669Total

50,51352,406

102,919▪ No statistical signals to date* for any pre-specified surveillance outcomes for
either mRNA COVID-19 vaccine* Data through Aug 13, 2022

17

Summary: mRNA COVID-19 vaccine safety of primary series vaccinationin children ages 6 months–5 years▪ Initial safety findings of both mRNA COVID-19 vaccines (Pfizer-BioNTech andModerna) are consistent with those observed in the clinical trials▪ Systemic and local reactions are commonly reported adverse events▪ Vaccination errors are also being reported to VAERS▪ No unexpected safety findings to date

▪ No evidence of an increased risk for myocarditis following mRNA COVID-19
vaccination in children ages 6 months–5 years

18

COVID-19 vaccine safety of booster doses inpeople ages 5 years and older

19

U.S. reports to VAERS following 1st and 2nd mRNA COVID-19
booster vaccinations* (as of August 21, 2022)
Male‡
n (%)

Female‡n (%)

Non-seriousn (%)

Seriousn (%)

9 years

369 (51)348 (48)723 (99)

4 (1)64,26553 years

21,841 (34) 41,234 (64)57,048 (89)7,217 (11)12,61968 years

4,556 (36)

11,895 (94)724 (6)

Boosterdose

Doses
admin†

1st booster

1,153,611

727

1st booster 102,063,616
2nd booster(5–11 years)(≥12 years)(≥50 years)

20,145,400

Total Medianreportsage

7,973 (63)

* Among persons receiving Pfizer-BioNTech dose 3: children ages 5–11 years vaccinated during May 17–August 21, 2022; children and adolescents ages 12–15 years vaccinatedduring January 3–August 21, 2022, and ages 16–17 years vaccinated during December 9, 2021–August 21, 2022; adults ages ≥18 years vaccinated during September 22, 2021–
August 21, 2022. Among persons receiving Moderna dose 3: adults ages ≥18 years vaccinated during October 20, 2021–August 21, 2022. Among persons ages ≥50 years: dose 4
Pfizer-BioNTech or Moderna vaccine received during March 29–August 21, 2022.
† Doses of Pfizer-BioNTech dose 3 administered among children ages 5–11 years during June 16–August 18, 2022; children and adolescents ages 12–15 years during January 6–

August 18, 2022; adolescents ages 16–17 years during December 9, 2021–August 18, 2022; adults ages ≥18 years during September 22, 2021–August 18, 2022. Doses of Modernadose 3 administered among adults ages ≥18 years during October 28, 2021–August 18, 2022. Among adults ages ≥50 years, 2nd booster dose of Pfizer-BioNTech or Moderna
vaccine administered during March 28–August 18, 2022.
‡ Sex was not reported in approximately 2% of reports.

20

Most frequent MedDRA Preferred Terms* in reports to VAERS following 1st booster dosemRNA COVID-19 vaccinations, ages 5–11 years† (as of August 21, 2022)
N=727, all reports

N=727, clinical outcomes only shown‡

Rank

MedDRA PT (not mutually exclusive)

n (%)

Rank

MedDRA PT (not mutually exclusive)

n (%)

1

Product Preparation Issue

197 (27)

1

Pyrexia/Fever

51 (7)

2

Incorrect Dose Administered

164 (23)

2

Pain In Extremity40 (6)

3

No Adverse Event

139 (19)

3

Fatigue37 (5)

4

Product Preparation Error

69 (9)

4

Vomiting

27 (4)

5

Product Administered To Patient Of
Inappropriate Age

67 (9)

5

Dizziness

24 (3)

6

Expired Product Administered53 (7)

6

Headache23 (3)

7

Pyrexia/Fever

51 (7)

7

Injection Site Pain

23 (3)

8

Pain In Extremity40 (6)

8Pain

21 (3)

9

Fatigue37 (5)

9

Chills18 (2)

10

Vomiting

27 (4)

10

Lymphadenopathy

18 (2)* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)† Among children ages 5–11 years receiving Pfizer-BioNTech dose 3 during May 17–August 21, 2022; reports received and processed as of August 23, 2022
‡ Determined by subject matter expert review

21

Most frequent MedDRA Preferred Terms* in reports to VAERS following 1st booster dosemRNA COVID-19 vaccinations, ages ≥12 years† (as of August 21, 2022)
N=57,048, non-serious reports (clinical outcomes)

N=7,217, serious reports (clinical outcomes)

Rank

Adverse event (not mutually exclusive)

n (%)

Rank

Adverse event (not mutually exclusive)

n (%)

1

Headache

7,006 (12)1

COVID-19

2,479 (34)2Pyrexia/Fever

6,804 (12)2

SARS-CoV-2 Test Positive

2,017 (28)

3

Pain

6,702 (12)3

Dyspnoea

1,223 (17)4Fatigue

6,542 (11)

4

Death

794 (11)5

Chills

5,310 (9)5Asthenia

730 (10)

6COVID-19

4,957 (9)6Pyrexia/Fever

651 (9)

7

Pain In Extremity

4,272 (7)7

Fatigue

646 (9)

8

Nausea3,548 (6)8

Vaccine Breakthrough Infection

618 (9)9Dizziness

3,353 (6)9

Condition Aggravated615 (9)10

Urticaria

3,240 (6)10

Chest Pain

578 (8)* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)† Among persons receiving Pfizer-BioNTech dose 3: children and adolescents ages 12–15 years vaccinated during January 3–August 21, 2022, and ages 16–17 years vaccinated during

December 9, 2021–August 21, 2022; adults ages ≥18 years vaccinated during September 22, 2021–August 21, 2022. Among persons receiving Moderna dose 3: adults ages ≥18 years
vaccinated during October 20, 2021–August 21, 2022.

22

Most frequent MedDRA Preferred Terms* in reports to VAERS following 2nd booster dosemRNA COVID-19 vaccinations, ages ≥50 years† (as of August 21, 2022)
N=11,895, non-serious reports (clinical outcomes)

N=724, serious reports (clinical outcomes)

Rank

Adverse event (not mutually exclusive)

n (%)

Rank

Adverse event (not mutually exclusive)

n (%)

1

COVID-19

3,951 (33)1

COVID-19

218 (30)

2

SARS-CoV-2 Test Positive

2,757 (23)2

SARS-CoV-2 Test Positive

165 (23)

3

Fatigue

2,057 (17)3

Dyspnoea

91 (13)

4

Cough1,724 (14)4Asthenia

76 (11)

5

Headache

1,645 (14)5

Fatigue76 (11)

6

Pyrexia/Fever

1,622 (14)

6

Death

66 (9)

7Pain

1,247 (10)7

Vaccine Breakthrough Infection

65 (9)

8

Oropharyngeal Pain

1,235 (10)8

Headache64 (9)

9

Rhinorrhoea

838 (7)

9

Cough

60 (8)

10

Malaise811 (7)

10

Pyrexia/Fever

60 (8)* Medical Dictionary for Regulatory Activities Preferred Terms (https://www.meddra.org/how-to-use/basics/hierarchy)† Among persons receiving Pfizer-BioNTech or Moderna dose 4 during March 29–August 21, 2022

23

VAERS reporting rates of verified myocarditis per 1 million mRNA COVID-19 1st and2nd booster vaccinations (Pfizer-BioNTech or Moderna), days 0–7 post-vaccination*,†1st booster (≥5 years)

2nd booster (≥50 years)

Age group

Male

FemaleMale

Female

5–11 years
12–15 years
16–17 years
18–24 years
25–29 years
30–39 years
40–49 years
50–64 years
65+ years

0.0
12.9
21.6
13.1
4.4
1.9
0.2
0.4
0.7

0.0
0.7
0.0
0.6
2.2
0.9
0.6
0.1
0.2

0.0
0.0

0.3
0.0

* As of August 18, 2022. Reports verified to meet case definition by provider interview or medical record review.
† 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 days 0–7

risk interval, this estimated background is 0.2 to 2.2 per 1 million person-day 0–7 risk interval (peach shaded cells indicate that reporting rate exceeded estimatedbackground incidence for the period)

24

VAERS reporting rates of verified myocarditis per 1 million mRNA COVID-19 vaccinations(Pfizer-BioNTech and Moderna combined), days 0–7 post-vaccination*,†

Dose 2(primary series)

Age group

Male

Female

5–11 years
12–15 years
16–17 years
18–24 years
25–29 years
30–39 years
40–49 years
50–64 years
65+ years

2.5
47.1
78.7
39.3
15.3
7.8
3.3
0.7
0.3

0.7
4.2
7.4
3.9
3.5
1.0
1.6
0.5
0.5

1st booster
dose
Male
Female
0.0
12.9
21.6
13.1
4.4
1.9
0.2
0.4
0.7

From
previous
slide

0.0
0.7
0.0
0.6
2.2
0.9
0.6
0.1
0.2

* As of August 18, 2022. Reports verified to meet case definition by provider interview or medical record review.
† 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 days 0–7

risk interval, this estimated background is 0.2 to 2.2 per 1 million person-day 0–7 risk interval (peach shaded cells indicate that reporting rate exceeded estimatedbackground incidence for the period)

25

Reactions and health impact events reported by v-safe participants aged 5-11 years
at least once in days 0-7 after homologous Pfizer-BioNTech vaccination, by dose
100

90
80

Percentage

70
60
50
40
30

20
10
0

Any injection site
reaction

Any systemic reaction

Any health impact

Dose 1

Dose 2

Unable to performdaily activities

Unable to work or
attend school

Needed medical care

Booster

Includes 3,622 participants who completed at least one survey in the first week after each dose, data collected during May 17–Aug 21, 2022

26

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
100

90
80

Percentage

70
60
50
40
30

20
10
0

Any injection site
reaction

Any systemic reaction

Any health impact

Dose 1

Dose 2

Unable to performdaily activities

Unable to work or
attend school

Needed medical care

Booster

Includes 4,369 participants who completed at least one survey in the first week after each dose, data collected during Dec 9, 2021–Aug 21, 2022

27

Reactions and health impact events reported by v-safe participants aged ≥18 years
at least once in days 0-7 after homologous vaccination, by doseModernaN = 316,097

100

90

90

80

80

70

70

Percentage

Percentage

100

60

50
40

60

50
40

30

30

20

20

10

10

0

0

Any injection site
reaction

Dose 1

Any systemic reaction Any health impact

Dose 2

Pfizer-BioNTech
N = 341,951

Booster

Any injection site
reaction

Dose 1

Any systemic
reaction

Dose 2

Any health impact

Booster

Includes participants who completed at least one survey in the first week after each dose, data collected during Sept 22, 2021–Aug 21, 2022

28

Reactions and health impact events reported by v-safe participants aged ≥50 years
at least once in days 0-7 after homologous vaccination, by doseModernaN = 131,730

100

90

90

80

80

70

70

Percentage

Percentage

100

60

50
40

60

50
40

30

30

20

20

10

10

0

0

Any injection site
reaction

Dose 1

Dose 2

Any systemic reaction Any health impact

Booster

Pfizer-BioNTech
N = 128,197

Second Booster

Any injection site
reaction

Any systemic
reaction

Dose 1

Booster

Dose 2

Any health impact

Second Booster

Includes participants who completed at least one survey in the first week after each dose, data collected during Mar 29–Aug 21, 2022

29

VSD COVID-19 vaccine RCA prespecified surveillance outcomes
Prespecified outcomes

EHR = Electronic
health record

Settings

Acute disseminated encephalomyelitis

Emergency dept, Inpatient

Acute myocardial infarction – First ever in EHR in ICD-10 era

Emergency dept, Inpatient

Acute respiratory distress syndrome

Emergency dept, Inpatient

Anaphylaxis – First in 7 days in EHR in ICD-10 era

Emergency dept, Inpatient

Appendicitis

Emergency dept, Inpatient

Bell’s palsy – First ever in EHR in ICD-10 era

Emergency dept, Inpatient, Outpatient

Cerebral venous sinus thrombosis

Emergency dept, Inpatient

Disseminated intravascular coagulation

Emergency dept, Inpatient

Encephalitis / myelitis / encephalomyelitis

Emergency dept, Inpatient

Guillain-Barré syndrome

Emergency dept, Inpatient

Immune thrombocytopenia

Emergency dept, Inpatient, Outpatient

Kawasaki disease

Emergency dept, Inpatient

Multisystem inflammatory syndrome in children/adults (MIS-C/MIS-A)

Emergency dept, Inpatient

Myocarditis / pericarditis – First in 60 days in EHR in ICD-10 era

Emergency dept, Inpatient

Narcolepsy / cataplexy

Emergency dept, Inpatient, Outpatient

Pulmonary embolism – First ever in EHR in ICD-10 era

Emergency dept, Inpatient

Seizures

Emergency dept, Inpatient

Stroke, hemorrhagic

Emergency dept, Inpatient

Stroke, ischemic

Emergency dept, Inpatient

Thrombosis with thrombocytopenia syndrome – First ever in EHR in ICD-10 era

Emergency dept, Inpatient

Thrombotic thrombocytopenic purpura

Emergency dept, Inpatient

Transverse myelitis

Emergency dept, Inpatient

Venous thromboembolism – First ever in EHR in ICD-10 era

Emergency dept, Inpatient, Outpatient

30

mRNA COVID-19 booster vaccine doses administered in VSD in people
ages 5–11, 12–17, and ≥18 years, over time** Data through Aug 13, 2022

31

VSD RCA results in children ages 5–11 years for 1st mRNA
COVID-19 booster vaccination*▪ No statistical signals for any pre-specified surveillance outcomes*Results through Aug 13, 2022

32

VSD signals for pre-specified outcomes in 21-day risk interval after 1st booster in people
ages 12 years and older

Results throughAug 13, 2022

* Analyses not yet
possible

Primary series with

Pfizer-Pfizer OR
Moderna-Moderna

Signal after 1st booster

Pfizer-Pfizer

Moderna-Moderna

Pfizer OR Moderna

PfizerSignal?

ModernaAcute disseminated encephalomyelitis

No

No

-*

Acute myocardial infarction

No

No

No

Appendicitis

No

No

No

Bell's palsy

No

No

No

Cerebral venous sinus thrombosis

No

No

No

Disseminated intravascular coagulation

No

No

No

Encephalitis / myelitis / encephalomyelitis

No

No

No

Guillain-Barre syndrome

No

No

No

Stroke, hemorrhagic

No

No

No

Stroke, ischemic

No

No

No

Immune thrombocytopenia

No

No

No

Myocarditis / pericarditis

Yes

No

No

Seizures

No

No

No

Transverse myelitis

No

No

No

Thrombotic thrombocytopenic purpura

No

No

No

Thrombosis with thrombocytopenia syndrome

No

No

No

Venous thromboembolism

No

No

No

Pulmonary embolism

No

No

No

VSD RCA pre-specified outcomes33

Verified myocarditis and pericarditis during the 0–7 risk interval post-vaccination versus thecomparison interval 22–42 days post-vaccination with 1st booster dose*

12–15-year-olds
Males
Females
16–17-year-olds
Males
Females
18–39-year-olds
Males
Males
Males
Females
Females
FemalesPrimary series

BoostervaccineCases
in riskinterval

Cases in
22–42-daycomparison
interval

Adjusted rate ratio(95% confidence
interval)

2-sidedp-value

Events/million doses(95% confidence
interval)

Pfizer – Pfizer
Pfizer – Pfizer

Pfizer
Pfizer40

1
018.50 (1.85 – 551.84)
NE (NE)0.011
NE

61.7 (20.0 – 143.9)**
0.0

Pfizer - Pfizer
Pfizer - Pfizer

Pfizer
Pfizer8
2

0
3

NE (2.03 - ∞)1.10 (0.11 – 9.49)

0.009
0.925

189.0 (86.4 – 358.8)**
36.6 (4.4 – 132.2)

Pfizer - Pfizer
ORModerna - Moderna
Pfizer - Pfizer
Moderna - Moderna
Pfizer - Pfizer
ORModerna - Moderna
Pfizer - Pfizer
Moderna - Moderna

PfizerOR
Moderna
PfizerModerna
PfizerOR
Moderna
PfizerModerna18

75.34 (2.11 – 14.74)<0.00130.9 (18.3 – 48.9)

10
5

3
3

8.15 (2.06 – 41.51)
3.57 (0.73 – 20.16)

0.002
0.116

31.3 (15.0 – 57.6)
25.4 (8.3 – 59.3)

43

2.68 (0.53 – 14.84)

0.227

4.9 (1.3 – 12.6)

1
1

2
1

0.99 (0.03 – 13.07)
2.42 (0.06 – 101.49)

0.969
0.599

2.2 (0.1 – 12.3)
10.7 (2.2 – 31.4)****Data through August 20, 2022** One additional case was in the risk interval but not included because there were no appropriate comparators. These cases are included in the events/million dose calculation.
***Two 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.

34

VSD incidence rates of verified myocarditis/pericarditis in the 0–7 days after
Pfizer-BioNTech vaccination in people ages 5–39 years, dose 2 and 1st booster*
1st booster dose
Pfizer-BioNTech

Dose 2 primary series
Pfizer-BioNTech
Cases

Dose 2admin

Incidence rate/
million doses (95% CI)

Cases

1st boosters
admin

Incidence rate/
million doses (95% CI)

5-11 years
Males
Females
12–15 years
Males
Females30207,958
202,59614.4 (3.0 – 42.2)
0.0 (0.0 – 14.8)

0050,41549,2610.0 (0.0 – 59.4)
0.0 (0.0 – 60.8)315205,955
204,074150.5 (102.3 – 213.6)
24.5 (8.0 – 57.2)

5
081,613
84,11461.3 (19.9 – 143.0)
0.0 (0.0 – 35.6)

16–17 years
Males
Females

14
1

102,091
107,173137.1 (75.0 – 230.1)
9.3 (0.2 – 52.0)9247,87455,004188.0 (86.0 – 356.9)
36.4 (4.4 – 131.3)

18–29 years
Males
Females27
2

331,889
400,32181.4 (53.6 – 118.4)
5.0 (0.6 – 18.0)

71

166,973240,226

41.9 (16.9 – 86.4)
4.2 (0.1 – 23.2)

30–39 years
Males
Females

5
3341,527
410,71314.6 (4.8 – 34.2)
7.3 (1.5 – 21.3)

3
1

197,554
268,41215.2 (3.1 – 44.4)
3.7 (0.1 – 20.8)*Primary series surveillance for people ages ≥18 years ended May 21, 2022, all other data through August 20, 2022.

35

VSD incidence rates of verified myocarditis/pericarditis in the 0–7 days after
Moderna vaccination in people ages 5–39 years, dose 2 and 1st booster*
1st booster doseModerna

Dose 2 primary series
ModernaCases

1st boosters
admin

Incidence rate/
million doses (95% CI)

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

N/A
N/A

18–29 years
Males
Females

19
0

195,809
243,560

97.0 (58.4 – 151.5)
0.0 (0.0 – 12.3)

7
1

109,337
156,70764.0 (25.7 – 131.9)
6.4 (0.2 – 35.6)

30–39 years
Males
Females8
1

216,583
259,78036.9 (15.9 – 72.8)
3.9 (0.1 – 21.4)

1
2

149,468
191,765

6.7 (0.2 – 37.3)
10.4 (1.3 – 37.7)

Cases

Dose 2admin

Incidence rate/
million doses (95% CI)

N/A
N/A

N/A
N/A

N/A
N/A

16–17 years**
Males
Females

5-11 years**
Males
Females
12–15 years**
Males
Females*Primary series surveillance for people ages ≥18 years ended May 21, 2022, all other data through August 20, 2022.
**Monitoring ongoing, no data provided if less than 2,500 doses given in a subgroup.

36

Summary: mRNA COVID-19 vaccine safety of booster doses in people
ages 5 years and older▪ Safety findings are generally consistent with those observed for primary series
vaccination▪ Evidence suggests an increased risk for myocarditis following 1st booster dose
• Myocarditis is a rare event following mRNA COVID-19 booster vaccination‒ CDC has verified 131 myocarditis case reports to VAERS in people ages ≥5 years after
123,362,627 million mRNA COVID-19 booster vaccinations• Risk primarily observed in adolescent and young adult males• No statistical signal for myocarditis to date in children ages 5–11 years following 1st booster▪ In VAERS data, reporting rates of myocarditis are lower following 1st booster
dose vs. dose 2 of primary series (and lower following dose 1 vs. dose 2 of primary series)▪ In VSD analyses, myocarditis/pericarditis incidence following 1st booster doseand dose 2 of the primary series are similar, though case counts are small andconfidence intervals around point estimates are wide

37

COVID-19 vaccine safety: pregnancy and reproductive healthoutcomes monitoring
Monitoring systems
•
•
•
•
•

V-safeV-safe pregnancy registry
VSD
VAERS
CISA

Outcomes/topics
•
•
•
•
•
•
•
•
•

Miscarriage
StillbirthPreterm birth
Birth defects
Pregnancy complications
Pregnancy outcomes
Infant outcomes
Neonatal outcomes
Maternal adverse eventsand maternal conditions• Menstrual irregularities• Post-menopausal bleeding• Safety of booster doses• SARS-CoV-2 infection after
vaccination• Co-administration with othervaccines (e.g., influenza)

38

COVID-19 vaccine safety: pregnancy and reproductive healthoutcomes monitoring▪ To date, for outcomes studied, there have been no concerning findings for
pregnancy and reproductive health outcomes following COVID-19 vaccination▪ Data on COVID-19 vaccine safety during pregnancy and reproductive healthoutcomes following vaccination will be presented at a future ACIP meeting39

Acknowledgments▪ VAERS Team▪ Kaiser Permanente Northern California (VSD)▪ V-safe Team▪ Marshfield Clinic Research Institute (VSD)▪ Clinical Immunization Safety Assessment(CISA) Project▪ VSD sites▪ Vaccine Safety Datalink (VSD) Team
▪ CDC Immunization Safety Office▪ COVID-19 Vaccine Task Force Data
Monitoring and Reporting Group• HealthPartners Institute, Minneapolis, MN• Kaiser Permanente Colorado, Denver, CO• Kaiser Permanente Northwest, Portland, OR• Kaiser Permanente Southern California, Los Angeles, CA• Kaiser Permanente Washington, Seattle, WA• Denver Health, Denver, CO▪ FDA/Center for Biologics Evaluation andResearch

40

Disclaimer▪ The findings and conclusions in this report are those of the authorsand do not necessarily represent the official position of the Centers
for Disease Control and Prevention (CDC) or the U.S. Food and Drug
Administration (FDA)▪ Mention of a product or company name is for identification
purposes only and does not constitute endorsement by CDC or FDA

41

Thank you!

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 theofficial position of the Centers for Disease Control and Prevention.