This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA COVID-19 Vaccine and Any Commercially Available Influenza Vaccines at the Same Time Versus at Different Times.

Study Overview
=================
Brief Summary
-----------------
This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.

Official Title
-----------------
Investigating Uptake and Subsequent Health Outcomes Associated With Pfizer-BioNTech Bivalent COVID-19/Influenza Vaccine Concomitant Administration Using a Claims-based Real-world Data Source in the US

Conditions
-----------------
Influenza, Human, COVID-19

Intervention / Treatment
-----------------
* Biological: Comirnaty
* Biological: Quadrivalent Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in Optum claims database as of 31 August 2022 (date bivalent authorized). Has a Pfizer-BioNTech mRNA bivalent COVID-19 or influenza vaccine (any type) between 31 August 2022 and 30 January 2023 (earliest vaccine is index date). Aged >=18 years on the index date 365 days of continuous enrolment prior to index date Exclusion Criteria: Patients with a second dose of any type of bivalent mRNA COVID-19 or flu vaccine, disenrolled or died within 14 days following the first dose. Has prior COVID-19 diagnosis (U07.1, any setting, any position) within 90 days (per CDC guidance on length of time before receiving a vaccine) before and on index. Has influenza vaccine between 01 August -30 August 2022 (before study period). Has a COVID-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Same day<br>Pfizer-BioNTech mRNA bivalent COVID and flu on the same day | Biological: Comirnaty<br>* COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.<br>Biological: Quadrivalent Influenza Vaccine<br>* Quadrivalent Influenza Vaccine is a class of vaccines indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccines<br>|
| COVID alone<br>Pfizer-BioNTech bivalent COVID only | Biological: Comirnaty<br>* COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.<br>|
| flu alone<br>influenza vaccine of any type only | Biological: Quadrivalent Influenza Vaccine<br>* Quadrivalent Influenza Vaccine is a class of vaccines indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of COVID-related hospitalization/emergency department visit/urgent care visit | An acute inpatient admission or an emergency department/urgent care claim with a diagnosis of COVID-19 in any coding position | Baseline - greater than 14 days after index vaccination | 
| Number of COVID-related outpatient visit (excluding ER/urgent care) | An outpatient claim with a diagnosis of COVID-19 in any coding position, excluding visits with an ER/urgent care place of service code | Baseline - greater than 14 days after index vaccination | 
| Number of Influenza-related hospitalization/emergency department visit/urgent care visit | An acute inpatient admission or an emergency department/urgent care claim with a diagnosis of influenza in any coding position | Baseline - greater than 14 days after index vaccination | 
| Number of Influenza-related outpatient visit (excluding ER/urgent care) | An outpatient claim with a diagnosis of influenza in any coding position, excluding visits with an ER/urgent care place of service code | Baseline - greater than 14 days after index vaccination | 
| Number of All-cause hospitalization | An acute inpatient admission for any cause | Baseline - greater than 14 days after index vaccination | 
| Number of COVID-related hospitalization | An acute inpatient admission with a diagnosis of COVID-19 in any coding position | Baseline - greater than 14 days after index vaccination | 
| Number of COVID-related emergency department visit/urgent care visit | An emergency department/urgent care claim with a diagnosis of COVID-19 in any coding position | Baseline - greater than 14 days after index vaccination | 
| Number of Influenza-related hospitalization | An acute inpatient admission with a diagnosis of influenza in any coding position | Baseline - greater than 14 days after index vaccination | 
| Number of Influenza-related emergency department visit/urgent care visit | An emergency department/urgent care claim with a diagnosis of influenza in any coding position | Baseline - greater than 14 days after index vaccination |