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.

Pfizer3,442,996 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

3,442,996

Conditions

Influenza, Human COVID-19

Interventions

ComirnatyBIOLOGICAL

COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

Quadrivalent Influenza VaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Pfizer

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old

Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs Flu (SIV) alone.

Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)

Number of Participants With All Cause Hospitalization Visits: >=65 Years Old

Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone

Hospitalization, emergency department or urgent care visits with COVID-19 diagnosis code (International Classification of Diseases, 10th revision \[ICD-10-CM\]: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.

Data from ClinicalTrials.gov

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Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone

Hospitalization, emergency department or urgent care visits with Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.

Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone

COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.

Time frame: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)

Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone

Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.

Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone

COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.

Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone

Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.

Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone

Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone