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

Stopped early

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT06703190

Run by

Pfizer

People needed

1

Starts

2024-11-25

Expected to finish

2025-06-06

Last updated by the study team

2025-11-06

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• Pfizer — New York, New York, United States

Full record on ClinicalTrials.gov

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