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

TerminatedN/A

Sponsor: Pfizer

Conditions: COVID-19

Interventions: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated, Not vaccinated with 2024-2025 formulated COVID-19 vaccine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 5 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

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.

Locations (1)

New York, New York, United States