Estimated Vaccine Effectiveness and Durability of Pfizer/BioNTech 2024-2025 COVID-19 Vaccine

Active, not recruiting

• Conditions: COVID-19
• Interventions: Biological: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated; Biological: Not vaccinated with 2024-2025 formulated COVID-19 vaccine

• Registration Number: NCT06703190
• Lead Sponsor: Pfizer

Brief Summary

This study is a retrospective case control analysis on the real-world effectiveness of the Pfizer-BioNTech BNT162b2 vaccine (2024-2025 formulation) against symptomatic SARS-CoV-2 infection among CVS MinuteClinic patients testing for SARS-CoV-2, across different age groups, during periods of various variant circulation, and by months since receipt of vaccine ...

Detailed Description

Background:
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Study Start: 2024-11-25
• Study First Posted: 2024-11-25
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 22692

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. MinuteClinic Patients (at least 5 years of age) testing for SARS-CoV-2 on or after September 5th 2024 (at least 14 days after FDA approval of the updated 2024-2025 COVID-19 vaccine formulation); AND

2. At least one symptom reported on the ICATT questionnaire; AND

3. No evidence of a positive SARS-CoV-2 test or COVID-19 diagnosis (or COVID-19 antiviral medications picked up at CVS) within the prior 90 days; AND

4. Vaccine status reported on the ICATT questionnaire and/or ability to confirm receipt of the 2024-2025 formulated COVID-19 vaccine via CVS or Aetna records; AND

   1. Received Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation); OR
   2. Did not receive any 2024-2025 formulated COVID-19 vaccine (regardless of manufacturer)

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Exclusion Criteria

Patients meeting any of the following criteria will NOT be included in the study:

1. Those testing at drive-thru locations;
2. Those who tested but are without a completed ICATT questionnaire
3. Those with invalid test results
4. Those not reporting any symptoms
5. Those who received a 2024-2025 formulated COVID-19 vaccine other than from Pfizer/BioNTech (confirmed via a combination of patient- or provider-report and validation against CVS or Aetna vaccination data).
6. Those who received a 2024-2025 formulated COVID-19 vaccine <14 days prior to the test date.
7. Those who reported "prefer not to answer" for vaccination history (and no evidence from CVS vaccination or Aetna data that the patient had received the Pfizer/BioNTech COVID-19 vaccine [2024-2025 formulation]).
8. Those who tested multiple times during the study period.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants testing positive for COVID-19 (i.e., cases)	Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated	Participants testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom
Participants testing positive for COVID-19 (i.e., cases)	Not vaccinated with 2024-2025 formulated COVID-19 vaccine	Participants testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom
Participants testing negative for COVID-19 (i.e. negative controls)	Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated	Participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom
Participants testing negative for COVID-19 (i.e. negative controls)	Not vaccinated with 2024-2025 formulated COVID-19 vaccine	Participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom

Primary Outcome Measures

Name	Time	Method
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine	September 2024 - April 2025	Exposed Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were vaccinated with the 2024-2025 formulation of the Pfizer/BioNTech vaccine ≥14 days prior to testing.
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test negative for SARS-CoV-2 ≥14 days after receipt of vaccine	September 2024 - April 2025	Exposed Controls will be defined as patients testing negative for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were vaccinated with the 2024-2025 formulation of the Pfizer/BioNTech vaccine ≥14 days prior to testing.
Number of COVID-19 2024-2025 formulation unvaccinated patients who test negative for SARS-CoV-2	September 2024 - April 2025	Unexposed Controls will be defined as patients testing negative for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were not vaccinated with any 2024-2025 formulation of COVID-19 vaccine ≥14 days prior to testing.
Number of COVID-19 2024-2025 formulation unvaccinated patients who test positive for SARS-CoV-2	September 2024 - April 2025	Unexposed Cases will be defined as patients testing positive for SARS-CoV-2 infection by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom and were not vaccinated with any 2024-2025 formulation of COVID-19 vaccine ≥14 days prior to testing.

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States