Estimated Vaccine Effectiveness and Durability of Pfizer/BioNTech 2024-2025 COVID-19 Vaccine (C4591068)

Estimated Vaccine Effectiveness (VE) and Durability of Pfizer/BioNTech 2024-2025 COVID-19 (Coronavirus Disease 2019) Vaccine

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated; Biological: Not vaccinated with 2024-2025 formulated COVID-19 vaccine

Detailed Description

Background:

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.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include retrospectively gathered data from those testing for SARS-CoV-2 at a CVS MinuteClinic

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Biological: 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 Names: Exposed; Biological: 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.; Other Names: Unexposed
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	Biological: 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 Names: Exposed; Biological: 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.; Other Names: Unexposed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: CVS Caremark
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): June 6, 2025
• Study Completion (Actual): June 6, 2025

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): November 6, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Omicron; KP.2
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: C4591068; NCT06703190 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No