Study Stopped
This secondary data analysis of symptomatic CVS MinuteClinics patients testing for SARS-CoV-2 was terminated due to incomplete data on KP.2 vaccination status (exposure). Termination was not based on any safety concerns or regulatory requirements.
Estimated Vaccine Effectiveness and Durability of Pfizer/BioNTech 2024-2025 COVID-19 Vaccine
C4591068
2 other identifiers
observational
1
1 country
1
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 dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2024
CompletedFirst Posted
Study publicly available on registry
November 25, 2024
CompletedStudy Start
First participant enrolled
November 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2025
CompletedNovember 6, 2025
November 1, 2025
6 months
November 22, 2024
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine
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.
September 2024 - April 2025
Number of COVID-19 2024-2025 formulation unvaccinated patients who test positive for SARS-CoV-2
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.
September 2024 - April 2025
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test negative for SARS-CoV-2 ≥14 days after receipt of vaccine
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.
September 2024 - April 2025
Number of COVID-19 2024-2025 formulation unvaccinated patients who test negative for SARS-CoV-2
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.
September 2024 - April 2025
Study Arms (2)
Participants testing positive for COVID-19 (i.e., cases)
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)
Participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom
Interventions
Non-interventional observed exposure of the receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) ≥14 days before testing for SARS-CoV-2
The reference group will be no receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation), or any other 2024-2025 formulated COVID-19 vaccine, ≥14 days before testing for SARS-CoV-2.
Eligibility Criteria
The study population will include retrospectively gathered data from those testing for SARS-CoV-2 at a CVS MinuteClinic
You may qualify if:
- 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
- At least one symptom reported on the ICATT questionnaire; AND
- 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
- 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
- Received Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation); OR
- Did not receive any 2024-2025 formulated COVID-19 vaccine (regardless of manufacturer)
You may not qualify if:
- Patients meeting any of the following criteria will NOT be included in the study:
- Those testing at drive-thru locations;
- Those who tested but are without a completed ICATT questionnaire
- Those with invalid test results
- Those not reporting any symptoms
- 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).
- Those who received a 2024-2025 formulated COVID-19 vaccine \<14 days prior to the test date.
- 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 \[2024-2025 formulation\]).
- Those who tested multiple times during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- CVS Caremarkcollaborator
Study Sites (1)
Pfizer
New York, New York, 10001, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2024
First Posted
November 25, 2024
Study Start
November 25, 2024
Primary Completion
June 6, 2025
Study Completion
June 6, 2025
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.