Estimated Vaccine Effectiveness (VE) and Durability of Pfizer/BioNTech 2024-2025 COVID-19 (Coronavirus Disease 2019) Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated (Biological)
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
干预措施: Not vaccinated with 2024-2025 formulated COVID-19 vaccine (Biological)
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
干预措施: Pfizer-BioNTech BNT162b2 COVID-19 Vaccinated (Biological)
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
干预措施: Not vaccinated with 2024-2025 formulated COVID-19 vaccine (Biological)
结局指标
主要结局
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test positive for SARS-CoV-2 ≥14 days after receipt of vaccine
时间窗: September 2024 - April 2025
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.
Number of Pfizer/BioNTech 2024-2025 formulation vaccinated patients who test negative for SARS-CoV-2 ≥14 days after receipt of vaccine
时间窗: September 2024 - April 2025
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.
Number of COVID-19 2024-2025 formulation unvaccinated patients who test negative for SARS-CoV-2
时间窗: September 2024 - April 2025
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.
Number of COVID-19 2024-2025 formulation unvaccinated patients who test positive for SARS-CoV-2
时间窗: September 2024 - April 2025
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.
次要结局
未报告次要终点