# RFA-IP-22-004:Michigan-Ford Initiative to Measure Vaccine Effectiveness (MFIVE): Seasonal Influenza, COVID-19 and Respiratory Virus Vaccines

> **NIH ALLCDC U01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $1,400,000

## Abstract

Component A: Michigan-Ford Initiative to Measure Vaccine Effectiveness (MFIVE): Seasonal Influenza,
COVID-19, and Respiratory Virus Vaccines The use of active surveillance for medically-attended acute
respiratory illness (MAARI) in outpatient settings has been the cornerstone of vaccine effectiveness (VE)
monitoring in the U.S. for over a decade. As a part of the U.S. Flu VE Network for 10 years, the Michigan
Center for Respiratory Virus Research and Response has the expertise and the infrastructure to build upon the
findings of previous test-negative studies to support real-time VE assessments for SARS-CoV-2 and influenza
vaccines. Our primary goal is to build upon our previous efforts to evaluate the effectiveness of vaccines
against SARS-CoV-2 and influenza in prevention of MAARI. We will conduct VE surveillance throughout
Southeastern Michigan through recruitment of patients presenting at ambulatory clinics and testing centers
spanning two healthcare systems. Our enrollment sites are distributed throughout multiple communities in the
region, including clinics serving populations disproportionately impacted by infectious diseases. This study will
integrate analyses of antibodies, whole genome sequences of viruses, and detection of non-influenza, non-
SARS-CoV-2 respiratory viruses (e.g. RSV). We will use these evaluations to expand upon the test-negative
methodology to provide a more accurate and robust assessment of VE. Our specific objectives are as follows:
Objective 1. Determine vaccine effectiveness of influenza and COVID-19 vaccines in children and adults from
ambulatory settings. We will do this through active enrollment of individuals with MAARI, collection and testing
of respiratory specimens, and verification of health data and vaccination history.
Objective 2. Conduct viral genomic sequencing of influenza and SARS-CoV-2 for surveillance and to support
variant and clade-specific estimates of VE. We will leverage our existing, robust sequencing pipeline to provide
timely sequencing data from both research and clinically-collected respiratory specimens.
Objective 3. Efficiently maintain SARS-CoV-2 surveillance and COVID-19 vaccine effectiveness evaluations
among ambulatory patients during periods when influenza viruses are not circulating. We will accomplish this
through standardized queries of the electronic medical records of our two participating major medical centers,
with regular integration with state vaccination registry data. Our primary outcome will be rapid determinations of
vaccine effectiveness, through regular deliveries to CDC to support vaccine recommendations for the general
population and to inform selection and development of future vaccines.

## Key facts

- **NIH application ID:** 10908243
- **Project number:** 5U01IP001193-03
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** Emily Toth Martin
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** ALLCDC
- **Fiscal year:** 2024
- **Award amount:** $1,400,000
- **Award type:** 5
- **Project period:** 2022-09-30 → 2025-09-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908243

## Citation

> US National Institutes of Health, RePORTER application 10908243, RFA-IP-22-004:Michigan-Ford Initiative to Measure Vaccine Effectiveness (MFIVE): Seasonal Influenza, COVID-19 and Respiratory Virus Vaccines (5U01IP001193-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10908243. Licensed CC0.

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