Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Test Negative Design Outcome: VE calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with 2 doses with BNT162b2 for hospitalized cases and controls, multiplied by 100%. |
To estimate the effectiveness of 2 doses of BNT162b2 against hospitalization for Acute Respiratory Infection due to SARS-CoV-2 infection |
up to three years |
|
Primary |
Cohort Design Outcome: VE calculated as 1 minus the hazard ratio (HR) comparing the incidence of 2 doses with BNT162b2 for hospitalization due to SARS-CoV-2 infection and not, multiplied by 100%. |
To estimate the effectiveness of 2 doses of BNT162b2 against hospitalization due to SARS-CoV-2 infection |
up to three years |
|
Primary |
VE of XBB.1.5-adapted monovalent vaccine against hospitalization |
chart reviews focused on the identification of hospitalizations that are clearly not for COVID-19. |
up to three years |
|
Primary |
VE of XBB.1.5-adapted monovalent vaccine against critical illness |
Chart confirmed COVID-19 related to critical illness (death, mechanical ventilation, ICU) |
up to three years |
|
Primary |
VE of XBB.1.5-adapted monovalent against outpatient visits |
Number of patients with identified acute respiratory illness (ARI) diagnosis |
up to three years |
|
Primary |
VE of XBB.1.5-adapted monovalent vaccine against UC/ED visits. |
Number of patients with identified acute respiratory illness (ARI) diagnosis |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of being vaccinated with 2 doses BNT162b2 for ED cases and controls, multiplied by 100% |
To estimate the effectiveness of 2 doses of BNT162b2 against ED admission (without subsequent hospitalization) for ARI due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of being partially vaccinated with BNT162b2 (only 1 dose) for hospitalized cases and controls, multiplied by 100%. |
To describe the effectiveness of only 1 dose of BNT162b2 (i.e., partially vaccinated) against hospitalization for ARI due to SARS-CoV-2 infection. |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of being partially vaccinated with BNT162b2 (only 1 dose) for ED cases and controls, multiplied by 100%. |
To describe the effectiveness of only 1 dose of BNT162b2 (i.e., partially vaccinated) against ED admission (without subsequent hospitalization) for ARI due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of ever being vaccinated (=1 dose) with BNT162b2 for hospitalized cases and controls, multiplied by 100%. |
To describe the effectiveness of =1 dose of BNT162b2 (i.e., ever vaccinated) against hospitalization for ARI due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of ever being vaccinated (=1 dose) with BNT162b2 for ED cases and controls, multiplied by 100%. |
To describe the effectiveness of =1 dose of BNT162b2 (i.e., ever vaccinated) against ED admission (without subsequent hospitalization) for ARI due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of >2 doses with BNT162b2 for hospitalized cases and controls, multiplied by 100%. |
To describe the effectiveness of >2 doses of BNT162b2 against hospitalization for ARI due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the OR comparing the odds of >2 doses with BNT162b2 for ED cases and controls, multiplied by 100%. |
To describe the effectiveness of >2 doses of BNT162b2 against ED admission (without subsequent hospitalization) for ARI due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Test Negative Design Outcome: BNT162b2 VE estimates stratified by virus variant (as determined by genome sequencing) and select descriptive analyses described above by number of doses received |
To further describe the effectiveness of BNT162b2 against hospitalization and ED admission stratified by prevalent or important viral strains |
up to three years |
|
Secondary |
Test Negative Design Outcome: BNT162b2 VE estimates against severe outcomes including ICU admission, mechanical ventilation, and death by number of doses received. |
To evaluate the effectiveness of BNT162b2 against severe hospitalization-related outcomes (e.g., ICU admission, mechanical ventilation, and death) |
up to three years |
|
Secondary |
Test Negative Design Outcome: Monthly VE estimates between variants of interest using independent Z tests of log hazard ratios. |
To evaluate overall and variant-specific effectiveness of BNT162b2 against SARS-CoV-2 infections and COVID-19 related hospital admissions by time since vaccination (by month) |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with BNT162b2 BA.4/BA.5 bivalent booster for hospitalized cases and controls, multiplied by 100%. |
To estimate the effectiveness of the BNT162b2 BA.4/BA.5 bivalent booster against hospitalization for ARI due to SARS-CoV-2 infection. |
up to three years |
|
Secondary |
Test Negative Design Outcome: VE calculated as 1 minus the odds ratio (OR) comparing the odds of being vaccinated with BNT162b2 BA.4/BA.5 bivalent for emergency room admissions/urgent care visit cases and controls, multiplied by 100%. |
To estimate the effectiveness of the BNT162b2 BA.4/BA.5 bivalent booster against emergency room admissions/urgent care vists for ARI due to SARS-CoV-2 infection. |
up to three years |
|
Secondary |
Cohort Design Outcome: VE calculated as 1 minus the HR comparing the incidence of 2 doses with BNT162b2 for ED admission due to SARS-CoV-2 infection and not, multiplied by 100%. |
To estimate the effectiveness of 2 doses of BNT162b2 against ED admission (without subsequent hospitalization) ED admission due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Cohort Design Outcome: VE calculated as 1 minus the HR comparing the incidence of 2 doses with BNT162b2 for ICU admission due to SARS-CoV-2 infection and not, multiplied by 100%. |
To estimate the effectiveness of 2 doses of BNT162b2 against ICU admission due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Cohort Design Outcome: VE calculated as 1 minus the HR comparing the incidence of (2 doses with BNT162b2 for death due to SARS-CoV-2 infection and not, multiplied by 100%. |
To estimate the effectiveness of 2 doses of BNT162b2 against death due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Cohort Design Outcome: VE calculated as 1 minus the HR comparing the incidence of 2 doses with BNT162b2 for COVID-19 outpatient visits (without subsequent hospitalization within 14 days) due to SARS-CoV-2 infection and not, multiplied by 100%. |
To estimate the effectiveness of 2 doses of BNT162b2 against COVID-19 outpatient visits (without subsequent hospitalization within 14 days) due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Cohort Design Outcome: VE = 1 minus the HR comparing the incidence of 1 dose of BNT162b2 for hospitalization, ED visit, death, and COVID-19 outpatient visits (without subsequent hosp. within 14 days) due to SARS-CoV-2 and not, multiplied by 100%. |
To describe the effectiveness of only 1 dose of BNT162b2 (i.e., partially vaccinated) against hospitalization, ED admission, ICU admission, death, and outpatient visits (without subsequent hospitalization within 14 days) due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Cohort Design Outcome: VE = 1 minus the HR comparing the incidence =1 dose of BNT162b2 (for hospitalization, ED visit, death, and COVID-19 outpatient visits (without subsequent hosp. within 14 days) due to SARS-CoV-2 and not, multiplied by 100%. |
To describe the effectiveness of =1 dose of BNT162b2 (i.e., ever vaccinated) against hospitalization, ICU admission, ED admission, death, and outpatient visits (without subsequent hospitalization within 14 days) due to SARS-CoV-2 infection |
up to three years |
|
Secondary |
Cohort Design Outcome: VE = 1 minus the HR comparing the incidence of >2 doses of BNT162b2 for hospitalization, ED visit, death, and COVID-19 outpatient visits (without subsequent hosp. within 14 days) due to SARS-CoV-2, multiplied by 100%. |
To describe the effectiveness of >2 doses of BNT162b2 against hospitalization, ED admission, ICU admission, death, and outpatient visits (without subsequent hospitalization within 14 days) due to SARS-CoV-2 infection. |
up to three years |
|
Secondary |
XBB.1.5 -adapted monovalent vaccine against critical illness |
To describe the effectiveness of XBB.1.5-adapted monovalent vaccine against critical illness (intensive care unit admissions, mechanical ventilation, or inpatient death confirmed by chart review to be COVID-19 related), emergency department, and urgent care visits. |
up to three years |
|
Secondary |
XBB.1.5-adapted monovalent vaccine against outpatient encounters |
To describe the effectiveness of XBB.1.5-adapted monovalent vaccine against outpatient encounters. |
up to three years |
|