Drug Use Investigation of COMIRNATY Intramuscular Injection

Study Overview
=================
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.

Official Title
-----------------
General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage)

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Biological: BNT162b2


Participation Criteria
=================
Eligibility Criteria
-----------------
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 exclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COMIRNATY<br>COVID-19 mRNA vaccine (nucleoside-modified) | Biological: BNT162b2<br>* 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.<br>* Other names: COMIRNATY;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects with serious Adverse Events | The long-term safety of this product will be assessed.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. | 11 months from the day following 28 days after the final vaccination of COMIRNATY | 
| Proportion of subjects withe serious Adverse Events | The long-term safety of this product will be assessed.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. | 11months from the day following 28days after the final vaccination of COMIRNATY | 
| Number of subjects with severe COVID-19 | The long-term safety of this procuct will be assessed.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. | 11 months from the day following 28 days after the final vaccination of COMIRNATY | 
| Proportion of subjects with severe COVID-19 | The long-term safety of this produt will be assessed.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. | 11 months from the day following 28 days after final vaccination of COMIRNATY | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Post-Marketing study, COMIRNATY,Vaccine