Estimated Vaccine Effectiveness and Durability of Pfizer/BioNTech 2024-2025 COVID-19 Vaccine
NCT ID: NCT06703190
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2024-11-25
2025-06-06
Brief Summary
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Detailed Description
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Omicron and its sublineages have comprised of the majority of SARS-CoV-2 genomes sequenced by the Centers for Disease Control and Prevention (CDC) since December 2021. KP.2 was first identified as a circulating variant under monitoring (VUM) by the World Health Organization in March 2024. FLiRT-mutated subvariants (including KP.2 and recent FluQE-mutated subvariants) have been the predominant variants sequenced in the US throughout 2024. FLiRT-mutated sub-lineages are antigenically distant from prior circulating SARS-CoV-2 lineages, including Omicron XBB, Omicron BA.4/BA.5 and the original SARS-CoV-2 wild-type strain. While Omicron XBB-adapted vaccines provide some protection against a range of outcomes from FLiRT-mutated-related COVID-19, evidence suggests that vaccines better matched to currently circulating sub-lineages can help further improve protection against symptomatic disease and severe COVID-19. Following guidance from regulatory authorities on the requirements for strain changes, Pfizer/BioNTech filed data showing that the FLiRT-mutated-adapted (KP.2) monovalent COVID-19 vaccine generates improved responses against circulating sublineages, compared to the 2023-2024 Omicron XBB-adapted COVID-19 vaccine. On June 27, 2024, the Advisory Committee on Immunization Practices recommended an updated 2024-2025 COVID-19 vaccine for all persons aged ≥6 months, regardless of prior vaccination history. On August 22nd 2024, FDA approved the KP.2 strain COVID-19 vaccine (2024-2025 Formula) for those aged \>12 years ages and authorized its use in those 6 months through 11 years of age.
Research Question:
What is the real-world effectiveness of the Pfizer/BioNTech 2024-2025 formulation of the COVID-19 vaccine against symptomatic COVID-19, across different age groups, during periods when different subvariants are circulating, and by months since receipt of the 2024-2025 formulated COVID-19 vaccine dose?
Research Methods:
Population: In collaboration with CVS, Pfizer will conduct a retrospective study to analyze patients tested for SARS-CoV-2 on or after September 5th, 2024, which corresponds with 14 days following FDA approval of the 2024-2025 updated COVID-19 vaccine. CVS will leverage CVS MinuteClinic data on patients ≥5 years of age who are testing for SARS-CoV-2 to evaluate the effectiveness of the 2024-2025 Pfizer/BioNTech COVID-19 vaccine formulation against symptomatic SARS-CoV-2 infection.
Exposure: The exposure of interest will be receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) ≥14 days before testing for SARS-CoV-2. The reference group for the overall VE will be no receipt of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine (2024-2025 formulation) or any other 2024-2025 formulated COVID-19 vaccine regardless of prior vaccination history.
Outcome: 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. Controls will be defined as participants testing negative for SARS-CoV-2 by RAT at a CVS MinuteClinic and reporting at least one COVID-19 symptom during the same period.
Calculation: Estimated vaccine effectiveness will be calculated as 1 minus the odds ratio from logistic regression models multiplied by 100.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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
Not vaccinated with 2024-2025 formulated COVID-19 vaccine
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.
Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated
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
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
Not vaccinated with 2024-2025 formulated COVID-19 vaccine
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.
Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated
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
Interventions
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Not vaccinated with 2024-2025 formulated COVID-19 vaccine
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.
Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
5 Years
ALL
No
Sponsors
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CVS Caremark
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
New York, New York, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06703190
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4591068
Identifier Type: -
Identifier Source: org_study_id