Trial Outcomes & Findings for COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States (NCT NCT05020145)
NCT ID: NCT05020145
Last Updated: 2024-02-12
Results Overview
The incidence rate of breakthrough cases of SARS-CoV-2 infection was calculated as the number of participants who experienced the event divided by the observed time at risk and reported as incidence rate per 100 person-years. Rate of breakthrough SARS-CoV-2 infection among fully vaccinated participants was reported in this outcome measure.
COMPLETED
1277747 participants
From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)
2024-02-12
Participant Flow
Data of participants aged 12 years or more with at least 1 BNT162b2 vaccine claim between 10 Dec 2020 to 08 Jul 2021 examined for COVID-19 breakthrough infections (vaccination greater than equal to \[\>=\] 14 days after 2nd dose) in real-world practice, were retrieved from US HealthVerity database. Available data were extracted and evaluated during approximately 4 months of this retrospective observational study.
Participant milestones
| Measure |
BNT162b2 (Tozinameran): IC Cohort
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Overall Study
STARTED
|
225796
|
1051951
|
|
Overall Study
Fully Vaccinated
|
212945
|
963962
|
|
Overall Study
COMPLETED
|
225796
|
1051951
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=225796 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=1051951 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
Total
n=1277747 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.4 Years
STANDARD_DEVIATION 15.2 • n=225796 Participants
|
44.1 Years
STANDARD_DEVIATION 16.9 • n=1051951 Participants
|
46.1 Years
STANDARD_DEVIATION 17.1 • n=1277747 Participants
|
|
Sex/Gender, Customized
Female
|
127101 Participants
n=225796 Participants
|
558164 Participants
n=1051951 Participants
|
685265 Participants
n=1277747 Participants
|
|
Sex/Gender, Customized
Male
|
96835 Participants
n=225796 Participants
|
476804 Participants
n=1051951 Participants
|
573639 Participants
n=1277747 Participants
|
|
Sex/Gender, Customized
Unknown
|
1860 Participants
n=225796 Participants
|
16983 Participants
n=1051951 Participants
|
18843 Participants
n=1277747 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
The incidence rate of breakthrough cases of SARS-CoV-2 infection was calculated as the number of participants who experienced the event divided by the observed time at risk and reported as incidence rate per 100 person-years. Rate of breakthrough SARS-CoV-2 infection among fully vaccinated participants was reported in this outcome measure.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=212945 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=963962 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Incidence Rate of Breakthrough Cases of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
|
0.89 Events per 100 person-years
Interval 0.8 to 0.98
|
0.34 Events per 100 person-years
Interval 0.32 to 0.37
|
PRIMARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
Time to SARS-CoV-2 breakthrough infection was calculated as the number of days from Dose 2 of vaccination till first occurrence of a breakthrough SARS-CoV-2 infection.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=374 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=604 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Time to SARS-CoV-2 Breakthrough Infection
|
34.5 Days
Interval 22.0 to 58.0
|
33 Days
Interval 20.5 to 58.0
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants with emergency department visits who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed. Emergency department visits included an outpatient claim that occurs after the breakthrough COVID-19 diagnosis date or at the same time or episode of care.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=374 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=604 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Emergency Department Visits After SARS-CoV-2 Infection
|
95 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants with outpatient hospital visits who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed. Outpatient hospital visits included an outpatient claim that occurs after the breakthrough COVID-19 diagnosis date or at the same time or episode of care other than emergency department visits.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=374 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=604 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Outpatient Hospital Visits After SARS-CoV-2 Infection
|
146 Participants
|
164 Participants
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants with other outpatient visits (excluding emergency department visits and outpatient hospital visits) who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=374 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=604 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants With Other Outpatient Visits After SARS-CoV-2 Infection
|
309 Participants
|
527 Participants
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants hospitalized who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=374 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=604 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Hospitalized After SARS-CoV-2 Infection
|
74 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants admitted to ICU with or without Invasive Mechanical Ventilation (IMV) during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=74 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=50 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection
With ICU admission and no IMV usage
|
15 Participants
|
9 Participants
|
|
Number of Participants Admitted to Intensive Care Unit (ICU) During Hospitalization After SARS-CoV-2 Infection
With ICU admission and IMV usage
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants who received IMV with or without ICU admission during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=74 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=50 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection
With ICU admission and IMV usage
|
8 Participants
|
1 Participants
|
|
Number of Participants Who Received Invasive Mechanical Ventilation (IMV) During Hospitalization After SARS-CoV-2 Infection
No ICU admission with IMV usage
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From 14 days after Dose 2 of BNT162b2 vaccine up to COVID-19 vaccine breakthrough infection case or end of continuous enrollment, whichever occurred first (retrospective data was retrieved and observed during 4 months approximately)Population: Analysis population included fully vaccinated participants against COVID-19 in dataset during 10-Dec-2020 through 08-Jul-2021, at least 12 years old on index date, had continuous medical enrolment 12-month period prior to index date, with no prior COVID-19 diagnosis during baseline. Fully vaccinated was defined as \>=14 days of follow-up after Dose 2 of BNT162b2 vaccine. Here, N=participant who had at least 1 incidence of SARS-CoV-2 breakthrough infection were evaluable for this outcome measure.
In this outcome measure, number of participants who died during hospitalization who were fully vaccination and had SARS-CoV-2 breakthrough infection were analyzed.
Outcome measures
| Measure |
BNT162b2 (Tozinameran): IC Cohort
n=74 Participants
Participants with IC condition who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 were retrospectively observed in this cohort. Participants were considered immunocompromised if they had \>=1 hospitalization or \>=2 outpatient visits on separate dates on a healthcare claim indicated 1 or more IC condition or if they had usage of specific immunosuppressive (IS) medications during the 12-month baseline period (prior to index period). Index date was defined as the date of receipt of the 1st BNT162b2 dose.
|
BNT162b2 (Tozinameran): Non-IC Cohort
n=50 Participants
Participants who had at least 1 BNT162b2 vaccine claim between 10 December 2020 to 08 July 2021 and without evidence of immunocompromising condition were included in this reporting arm.
|
|---|---|---|
|
Number of Participants Died During Hospitalization After SARS-CoV-2 Infection
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)Population: Data was not collected and analyzed for this outcome measure as per Sponsor discretion.
Total duration of stay was total time spend by the participant for different types of hospitalization treatments, applicable for first hospitalization and/or readmissions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Dose 2 of COVID-19 vaccination till the end of study (retrospective data was retrieved and observed during 4 months of this study)Population: Data was not collected and analyzed for this outcome measure as per Sponsor discretion.
Total expenditure on HCRU was defined as total non-zero costs associated with any of the previously listed outpatient and inpatient encounters.
Outcome measures
Outcome data not reported
Adverse Events
BNT162b2 (Tozinameran): IC Cohort
BNT162b2 (Tozinameran): Non-IC Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER