Trial Outcomes & Findings for COVID-19 Vaccine Boosters in Patients With CKD (NCT NCT05022329)
NCT ID: NCT05022329
Last Updated: 2025-02-19
Results Overview
To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
273 participants
Primary outcome timeframe
One month
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Third Dose BNT162b2
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Overall Study
STARTED
|
137
|
136
|
|
Overall Study
COMPLETED
|
119
|
125
|
|
Overall Study
NOT COMPLETED
|
18
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-dialysis CKD participants only
Baseline characteristics by cohort
| Measure |
Third Dose BNT162b2
n=137 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=136 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Baseline two dose COVID-19 vaccine type
BNT162b2
|
81 Participants
n=137 Participants
|
81 Participants
n=136 Participants
|
162 Participants
n=273 Participants
|
|
Days between COVID-19 vaccine doses, median
First and second dose
|
28 Days
n=137 Participants
|
28 Days
n=136 Participants
|
28 Days
n=273 Participants
|
|
Days between COVID-19 vaccine doses, median
Second dose and third dose
|
253 Days
n=137 Participants
|
252 Days
n=136 Participants
|
252 Days
n=273 Participants
|
|
Age, Continuous
|
71 years
n=137 Participants
|
69 years
n=136 Participants
|
70 years
n=273 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=137 Participants
|
57 Participants
n=136 Participants
|
121 Participants
n=273 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=137 Participants
|
79 Participants
n=136 Participants
|
152 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Asian
|
66 Participants
n=137 Participants
|
67 Participants
n=136 Participants
|
133 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Black or African origin
|
10 Participants
n=137 Participants
|
13 Participants
n=136 Participants
|
23 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=137 Participants
|
29 Participants
n=136 Participants
|
62 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Other/multiracial
|
18 Participants
n=137 Participants
|
17 Participants
n=136 Participants
|
35 Participants
n=273 Participants
|
|
Race/Ethnicity, Customized
Missing
|
10 Participants
n=137 Participants
|
10 Participants
n=136 Participants
|
20 Participants
n=273 Participants
|
|
Baseline two dose COVID-19 vaccine type
mRNA-1273
|
56 Participants
n=137 Participants
|
55 Participants
n=136 Participants
|
111 Participants
n=273 Participants
|
|
eGFR category
30-44 ml/min per 1.73 m2
|
5 Participants
n=137 Participants
|
4 Participants
n=136 Participants
|
9 Participants
n=273 Participants
|
|
eGFR category
15-29 ml/min per 1.73 m2
|
1 Participants
n=137 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=273 Participants
|
|
eGFR category
<15 ml/min per 1.73 m2 (nondialysis)
|
2 Participants
n=137 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=273 Participants
|
|
eGFR category
Dialysis
|
129 Participants
n=137 Participants
|
128 Participants
n=136 Participants
|
257 Participants
n=273 Participants
|
|
Nondialysis CKD participants - eGFR by CKD-EPI
|
33 ml/min per 1.73 m2
n=8 Participants • Non-dialysis CKD participants only
|
31 ml/min per 1.73 m2
n=8 Participants • Non-dialysis CKD participants only
|
31 ml/min per 1.73 m2
n=16 Participants • Non-dialysis CKD participants only
|
|
Nondialysis CKD participants - Microalbumin to creatinine ratio
|
531 mg/mmol
STANDARD_DEVIATION 692 • n=8 Participants • Nondialysis CKD participants only
|
725 mg/mmol
STANDARD_DEVIATION 800 • n=8 Participants • Nondialysis CKD participants only
|
628 mg/mmol
STANDARD_DEVIATION 729 • n=16 Participants • Nondialysis CKD participants only
|
|
Dialysis modality
In-center hemodialysis
|
122 Participants
n=129 Participants • Only applicable to dialysis patients
|
119 Participants
n=128 Participants • Only applicable to dialysis patients
|
241 Participants
n=257 Participants • Only applicable to dialysis patients
|
|
Dialysis modality
Home hemodialysis
|
5 Participants
n=129 Participants • Only applicable to dialysis patients
|
5 Participants
n=128 Participants • Only applicable to dialysis patients
|
10 Participants
n=257 Participants • Only applicable to dialysis patients
|
|
Dialysis modality
PD
|
2 Participants
n=129 Participants • Only applicable to dialysis patients
|
4 Participants
n=128 Participants • Only applicable to dialysis patients
|
6 Participants
n=257 Participants • Only applicable to dialysis patients
|
|
Dialysis access
Central venous catheter
|
78 Participants
n=129 Participants • Only applicable for Dialysis patients
|
76 Participants
n=128 Participants • Only applicable for Dialysis patients
|
154 Participants
n=257 Participants • Only applicable for Dialysis patients
|
|
Dialysis access
Arteriovenous fistula or graft
|
49 Participants
n=129 Participants • Only applicable for Dialysis patients
|
48 Participants
n=128 Participants • Only applicable for Dialysis patients
|
97 Participants
n=257 Participants • Only applicable for Dialysis patients
|
|
Dialysis access
PD catheter
|
2 Participants
n=129 Participants • Only applicable for Dialysis patients
|
4 Participants
n=128 Participants • Only applicable for Dialysis patients
|
6 Participants
n=257 Participants • Only applicable for Dialysis patients
|
|
Dialysis vintage
|
2.6 years
n=129 Participants • For dialysis patients only
|
2.6 years
n=128 Participants • For dialysis patients only
|
2.6 years
n=257 Participants • For dialysis patients only
|
|
Cause of kidney disease
Ischemic nephropathy
|
34 Participants
n=137 Participants
|
25 Participants
n=136 Participants
|
59 Participants
n=273 Participants
|
|
Cause of kidney disease
Diabetes mellitus
|
63 Participants
n=137 Participants
|
63 Participants
n=136 Participants
|
126 Participants
n=273 Participants
|
|
Cause of kidney disease
Glomerulonephritis
|
20 Participants
n=137 Participants
|
26 Participants
n=136 Participants
|
46 Participants
n=273 Participants
|
|
Cause of kidney disease
Cystic kidney disease
|
3 Participants
n=137 Participants
|
7 Participants
n=136 Participants
|
10 Participants
n=273 Participants
|
|
Cause of kidney disease
Other/unknown
|
17 Participants
n=137 Participants
|
15 Participants
n=136 Participants
|
32 Participants
n=273 Participants
|
|
Prior COVID-19 infection
COVID-19 (RT-PCR confirmed)
|
5 Participants
n=137 Participants
|
3 Participants
n=136 Participants
|
8 Participants
n=273 Participants
|
|
Prior COVID-19 infection
Symptomatic COVID-19
|
2 Participants
n=137 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=273 Participants
|
|
Prior COVID-19 infection
COVID-19 hospitalization
|
2 Participants
n=137 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=273 Participants
|
|
Prior COVID-19 infection
COVID-19 intensive care unit admission
|
1 Participants
n=137 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=273 Participants
|
|
Comorbidities
Active smoker
|
7 Participants
n=137 Participants
|
5 Participants
n=136 Participants
|
12 Participants
n=273 Participants
|
|
Comorbidities
Chemotherapy (3 mo)
|
3 Participants
n=137 Participants
|
2 Participants
n=136 Participants
|
5 Participants
n=273 Participants
|
|
Comorbidities
Chronic obstructive lung disease
|
5 Participants
n=137 Participants
|
10 Participants
n=136 Participants
|
15 Participants
n=273 Participants
|
|
Comorbidities
Coronary artery disease
|
12 Participants
n=137 Participants
|
19 Participants
n=136 Participants
|
31 Participants
n=273 Participants
|
|
Comorbidities
Congestive heart failure
|
24 Participants
n=137 Participants
|
17 Participants
n=136 Participants
|
41 Participants
n=273 Participants
|
|
Comorbidities
Cerebrovascular disease
|
8 Participants
n=137 Participants
|
7 Participants
n=136 Participants
|
15 Participants
n=273 Participants
|
|
Comorbidities
Hepatitis B nonresponder (HbsAb ,10 mIU/ml)
|
52 Participants
n=137 Participants
|
58 Participants
n=136 Participants
|
110 Participants
n=273 Participants
|
|
Comorbidities
Hypertension
|
118 Participants
n=137 Participants
|
112 Participants
n=136 Participants
|
230 Participants
n=273 Participants
|
|
Comorbidities
Immunosuppression
|
3 Participants
n=137 Participants
|
4 Participants
n=136 Participants
|
7 Participants
n=273 Participants
|
|
Comorbidities
Malignancy (prior 5 yr)
|
9 Participants
n=137 Participants
|
9 Participants
n=136 Participants
|
18 Participants
n=273 Participants
|
|
Comorbidities
Myocardial infarction
|
17 Participants
n=137 Participants
|
8 Participants
n=136 Participants
|
25 Participants
n=273 Participants
|
|
Comorbidities
Obesity (BMI $30 kg/m2)
|
13 Participants
n=137 Participants
|
15 Participants
n=136 Participants
|
28 Participants
n=273 Participants
|
|
Comorbidities
Peripheral vascular disease
|
13 Participants
n=137 Participants
|
7 Participants
n=136 Participants
|
20 Participants
n=273 Participants
|
|
Comorbidities
Solid organ transplant
|
27 Participants
n=137 Participants
|
19 Participants
n=136 Participants
|
46 Participants
n=273 Participants
|
|
Comorbidities
Type 1 diabetes mellitus
|
6 Participants
n=137 Participants
|
5 Participants
n=136 Participants
|
11 Participants
n=273 Participants
|
|
Comorbidities
Type 2 diabetes mellitus
|
84 Participants
n=137 Participants
|
72 Participants
n=136 Participants
|
156 Participants
n=273 Participants
|
PRIMARY outcome
Timeframe: One monthPopulation: 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis.
To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Outcome measures
| Measure |
Third Dose BNT162b2
n=126 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=125 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
Anti-RBD
|
0.807 relative ratio
Standard Deviation 0.416
|
0.934 relative ratio
Standard Deviation 0.398
|
|
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
Anti-NP
|
0.0630 relative ratio
Standard Deviation 0.334
|
0.0415 relative ratio
Standard Deviation 0.169
|
|
Serum Level of Anti-RBD ( Anti Receptor Binding Domain )
Anti-spike
|
1.26 relative ratio
Standard Deviation 0.358
|
1.33 relative ratio
Standard Deviation 0.289
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis.
To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 3 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Outcome measures
| Measure |
Third Dose BNT162b2
n=119 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=121 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Serum Level of SARS-CoV-2 Antibodies
Anti-NP
|
0.0985 relative ratios
Standard Deviation 0.424
|
0.0665 relative ratios
Standard Deviation 0.178
|
|
Serum Level of SARS-CoV-2 Antibodies
Anti-RBD
|
0.787 relative ratios
Standard Deviation 0.479
|
0.941 relative ratios
Standard Deviation 0.499
|
|
Serum Level of SARS-CoV-2 Antibodies
Anit-Spike
|
1.14 relative ratios
Standard Deviation 0.389
|
1.24 relative ratios
Standard Deviation 0.360
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis.
To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 6 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate.
Outcome measures
| Measure |
Third Dose BNT162b2
n=28 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=29 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Serum Level of SARS-CoV-2 Antibodies
Anti-NP
|
0.0703 relative ratios
Standard Deviation 0.173
|
0.0711 relative ratios
Standard Deviation 0.132
|
|
Serum Level of SARS-CoV-2 Antibodies
Anti-RBD
|
0.658 relative ratios
Standard Deviation 0.438
|
0.819 relative ratios
Standard Deviation 0.463
|
|
Serum Level of SARS-CoV-2 Antibodies
Anti-Spike
|
1.16 relative ratios
Standard Deviation 0.403
|
1.30 relative ratios
Standard Deviation 0.302
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Study was terminated before 12 months visit occurred.
Determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 12 months
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 monthPopulation: Analysis on this subset was not feasible following study completion. The collaborating laboratory was unable to logistically perform this testing due to the resources required for Flow Cytometry, and therefore this secondary outcome was not analyzed.
In a subset of participants, assess cellular immunity through flow cytometry on PBMC and single-cell RNA sequencing prior to, one month, and 6 months following vaccine booster.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 daysPopulation: Population consists of only individuals who returned the completed survey.
Evaluate adverse events related to third dose of vaccine through a questionnaire within 48 hours to 14 days following third vaccine dose.
Outcome measures
| Measure |
Third Dose BNT162b2
n=129 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=126 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Adverse Event
Pain
|
67 Participants
|
76 Participants
|
|
Adverse Event
Redness
|
2 Participants
|
6 Participants
|
|
Adverse Event
Swelling
|
2 Participants
|
9 Participants
|
|
Adverse Event
Fever (38°C)
|
4 Participants
|
14 Participants
|
|
Adverse Event
Chills
|
8 Participants
|
19 Participants
|
|
Adverse Event
Fatigue
|
17 Participants
|
30 Participants
|
|
Adverse Event
Nausea or vomiting
|
6 Participants
|
10 Participants
|
|
Adverse Event
Diarrhea
|
2 Participants
|
2 Participants
|
|
Adverse Event
Myalgia
|
15 Participants
|
13 Participants
|
|
Adverse Event
Arthralgia
|
2 Participants
|
5 Participants
|
|
Adverse Event
Headache
|
12 Participants
|
15 Participants
|
|
Adverse Event
Any symptom
|
82 Participants
|
89 Participants
|
|
Adverse Event
Any severe symptom
|
10 Participants
|
12 Participants
|
|
Adverse Event
Any systemic symptom
|
36 Participants
|
55 Participants
|
|
Adverse Event
Antipyretic medication
|
29 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 1 monthPopulation: We did not systematically collect symptoms at 30 days following vaccine dose, but rather 2-14 days only. This outcome was not analyzed.
Evaluate adverse events related to third dose of vaccine through a questionnaire at 30 days following third vaccine dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 7 participants withdrew from each arm
Number of participants who experienced COVID-19 related hospitalizations by study groups.
Outcome measures
| Measure |
Third Dose BNT162b2
n=130 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=129 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Hospitalization
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 7 participants withdrew from each arm
Number of participants who experienced COVID-19 infections and symptomatic COVID-19 infections.
Outcome measures
| Measure |
Third Dose BNT162b2
n=130 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=129 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
COVID-19 Infections
Confirmed cases of COVID-19 Infections
|
11 Participants
|
15 Participants
|
|
COVID-19 Infections
Confirmed cases of COVID-19 Infections with symptoms
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: excludes 7 participants that withdrew from each arm.
Differences in death between study groups. Death was collected for 6 months following third dose (shorted from 12 months due to the introduction of the 4th dose).
Outcome measures
| Measure |
Third Dose BNT162b2
n=130 Participants
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=129 Participants
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Death
|
17 Participants
|
9 Participants
|
Adverse Events
Third Dose BNT162b2
Serious events: 23 serious events
Other events: 82 other events
Deaths: 17 deaths
Third Dose mRNA-1273
Serious events: 16 serious events
Other events: 89 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Third Dose BNT162b2
n=129 participants at risk；n=137 participants at risk
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=126 participants at risk；n=136 participants at risk
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Skin and subcutaneous tissue disorders
Axillary abscess
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
2/137 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Cardiac disorders
Cardiac arrest
|
2.9%
4/137 • Number of events 4 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
1.5%
2/136 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Cardiac disorders
Cardiogenic shock
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Gastrointestinal disorders
Colitis / Gastroenteritis
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
General disorders
Death, unspecified
|
2.2%
3/137 • Number of events 3 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
1.5%
2/136 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Renal and urinary disorders
End stage renal disease
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Injury, poisoning and procedural complications
Fracture
|
1.5%
2/137 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Cardiac disorders
Hypervolaemia
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Vascular disorders
Hypotension
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Vascular disorders
Ischaemic stroke
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Blood and lymphatic system disorders
Multiple myeloma
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Infections and infestations
Mycotic pseudoaneurysm of aorta
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.5%
2/137 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Renal and urinary disorders
Urinary tract infection
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.00%
0/136 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Blood and lymphatic system disorders
Anema
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Vascular disorders
Cerebral haemorrhage
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Vascular disorders
Cerebral Infarction
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Injury, poisoning and procedural complications
Fall
|
0.73%
1/137 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
1.5%
2/136 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Vascular disorders
Myocardial infarction
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Cardiac disorders
Peripheral swelling
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Nervous system disorders
Seizures
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Infections and infestations
Sepsis
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
2.2%
3/136 • Number of events 3 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Vascular disorders
Steal phenomenon
|
0.00%
0/137 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
0.74%
1/136 • Number of events 1 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
Other adverse events
| Measure |
Third Dose BNT162b2
n=129 participants at risk；n=137 participants at risk
This group received BNT162b2 (Pfizer-BioNTech) as their third dose.
|
Third Dose mRNA-1273
n=126 participants at risk；n=136 participants at risk
This group received mRNA-1273 (Moderna) as their third dose
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain
|
51.9%
67/129 • Number of events 67 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
60.3%
76/126 • Number of events 76 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Skin and subcutaneous tissue disorders
Redness
|
1.6%
2/129 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
4.8%
6/126 • Number of events 6 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Skin and subcutaneous tissue disorders
Swelling
|
1.6%
2/129 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
7.1%
9/126 • Number of events 9 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Immune system disorders
Fever (38 degrees)
|
3.1%
4/129 • Number of events 4 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
11.1%
14/126 • Number of events 14 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Immune system disorders
Chills
|
6.2%
8/129 • Number of events 8 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
15.1%
19/126 • Number of events 19 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Immune system disorders
Fatigue
|
13.2%
17/129 • Number of events 17 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
23.8%
30/126 • Number of events 30 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Gastrointestinal disorders
Nausea of vomiting
|
4.7%
6/129 • Number of events 6 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
7.9%
10/126 • Number of events 10 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
2/129 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
1.6%
2/126 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.6%
15/129 • Number of events 15 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
10.3%
13/126 • Number of events 13 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/129 • Number of events 2 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
4.0%
5/126 • Number of events 5 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
|
Nervous system disorders
Headache
|
9.3%
12/129 • Number of events 12 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
11.9%
15/126 • Number of events 15 • Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR. Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place