A risk-varying and perturbed self-controlled case series design for assessing the safety of COVID-19 vaccines in a large health care system
用于评估大型医疗保健系统中 COVID-19 疫苗安全性的风险变化和扰动自控病例系列设计
基本信息
- 批准号:10623332
- 负责人:
- 金额:$ 66.45万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-05-17 至 2026-04-30
- 项目状态:未结题
- 来源:
- 关键词:AddressAmericanArea Under CurveBlood coagulationCOVID-19 vaccinationCOVID-19 vaccineCOVID-19 vaccine evaluationCaliforniaCaringCase SeriesCharacteristicsClinicalClinical TrialsDataData SourcesDatabasesDetectionDoseEpidemiologistEvaluationFamilyFoundationsHealthcareHealthcare SystemsIncidenceIndividualLengthMeasuresMessenger RNAMethodologyMethodsModelingMonitorNaturePatientsPatternPersonsPolicy MakerPopulationPopulation HeterogeneityRaceRecommendationReportingResearchRiskSafetyScheduleSerious Adverse EventSignal TransductionSpecific qualifier valueStatistical ModelsSystemTimeUnited StatesVaccinatedVaccinationVaccineeVaccinesadverse event riskcombatdesignexperiencefightinghealth care service organizationmembernew technologynovelnovel strategiespandemic diseaseresponsesafety assessmentsafety studysocioeconomicssuccesstoolvaccine acceptancevaccine distributionvaccine evaluationvaccine hesitancyvaccine safety
项目摘要
PROJECT SUMMARY/ABSTRACT
Despite the success of the unprecedented COVID-19 vaccine rollout in the U.S., vaccine hesitancy is evident,
partly due to safety concerns about severe adverse events (SAEs) surrounding the novel technology of mRNA
COVID-19 vaccines and reports of blood clots following receipt of the Janssen COVID-19 vaccine. While
rigorous safety monitoring may help support COVID-19 vaccination, it is methodologically challenging to
thoroughly evaluate the safety of the two-dose mRNA COVID-19 vaccines and the one-dose Janssen COVID-
19 vaccine. Existing approaches can produce false positive and false negative signals when 1) risk windows
after vaccination are incorrectly specified, 2) a constant risk of SAEs during the risk window is wrongly
assumed, 3) factors that may influence receipt of the second dose of mRNA COVID-19 vaccines are not
accounted for, and 4) the nature of the risk of SAEs during potential overlapping risk windows of the first and
second doses of mRNA COVID-19 vaccines is not assessed.
In response to the FOA, PA-18-873, this proposal addresses the specific objective: “creation/evaluation of
statistical methodologies for analyzing data on vaccine safety, including data available from existing data
sources such as passive reporting systems or healthcare databases.” We propose to develop novel statistical
models to properly measure the risk of new COVID-19 vaccines by allowing the risk level to vary during
unknown risk windows and using a data-driven approach to define these risk windows. We will also create a
new metric for measuring the risk of SAEs considering both the risk level and the length of the risk window,
address the potential overlap of risk windows of two doses, and employ a propensity score model approach to
account for factors that may influence receipt of the second dose of mRNA COVID-19 vaccines. We will
establish these novel approaches to evaluate COVID-19 vaccine safety and will apply them to existing data
from members of Kaiser Permanente Southern California, a large, racially, and socio-economically diverse
population.
Through this research, we will detect SAEs of concern, better inform the public and policymakers about the
safety of COVID-19 vaccines, and generate vaccine safety information that may be helpful for clinicians to
deliver appropriate care to those at risk.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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Stanley Xu其他文献
Stanley Xu的其他文献
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{{ truncateString('Stanley Xu', 18)}}的其他基金
A risk-varying and perturbed self-controlled case series design for assessing the safety of COVID-19 vaccines in a large health care system
用于评估大型医疗保健系统中 COVID-19 疫苗安全性的风险变化和扰动自控病例系列设计
- 批准号:
10420952 - 财政年份:2022
- 资助金额:
$ 66.45万 - 项目类别:
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