COVID-19
Conditions
Keywords
COVID-19, Post-Marketing study, COMIRNATY,Vaccine
Brief summary
Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
Detailed description
The healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected. If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed. If booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and COVID-19 will be continuously obtained after booster vaccination.
Interventions
BIOLOGICALBNT162b2
Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose. Individuals 16 years of age and older.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who have participated in the Investigation of Health Status of Recipients Vaccinated First and have provided written consent to continue participation in this study.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Serious Adverse Events | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. | A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. |
| Proportion of Participants With Severe COVID-19 | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. | By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO. |
| Proportion of Participants With Serious Adverse Reactions | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. | A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. |
| Number of Participants With Serious Adverse Events After Booster Vaccination | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) | A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. |
| Number of Participants With Severe COVID-19 After Booster Vaccination | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) | By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO. |
| Number of Participants With Serious Adverse Reactions After Booster Vaccination | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) | A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COMIRNATY Intramuscular Injection The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events. | 14,537 |
| Total | 14,537 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No adverse event information (missing information) | 33 |
Baseline characteristics
| Characteristic | COMIRNATY Intramuscular Injection | — |
|---|---|---|
| Age, Customized ≥15 and <65 years | 14113 Participants | — |
| Age, Customized <15 years | 0 Participants | — |
| Age, Customized ≥65 years | 424 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9744 Participants | — |
| Sex: Female, Male Male | 4793 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14,537 | 0 / 13,695 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 120 / 14,537 | 48 / 13,695 |
Outcome results
Primary
Number of Participants With Serious Adverse Events After Booster Vaccination
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Population: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster | Number of Participants With Serious Adverse Events After Booster Vaccination | 48 Participants |
Primary
Number of Participants With Serious Adverse Reactions After Booster Vaccination
A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Population: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster | Number of Participants With Serious Adverse Reactions After Booster Vaccination | 2 Participants |
Primary
Number of Participants With Severe COVID-19 After Booster Vaccination
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Time frame: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)
Population: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster | Number of Participants With Severe COVID-19 After Booster Vaccination | 0 Participants |
Primary
Proportion of Participants With Serious Adverse Events
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster | Proportion of Participants With Serious Adverse Events | 0.83 Percentage of Participants |
Primary
Proportion of Participants With Serious Adverse Reactions
A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster | Proportion of Participants With Serious Adverse Reactions | 0.03 Percentage of Participants |
Primary
Proportion of Participants With Severe COVID-19
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Time frame: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster | Proportion of Participants With Severe COVID-19 | 0 Percentage of Participants |