Estimating Effectiveness of Influenza and COVID-19 Vaccines: The “Test-Negative” Design - Takeaways - MDSpire

Estimating Effectiveness of Influenza and COVID-19 Vaccines: The “Test-Negative” Design

  • By

  • Josh Michaud

  • Jennifer Kates

  • April 30, 2026

  • 0 min

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  • 1

    The CDC's unpublished study on COVID-19 vaccine effectiveness used a widely accepted test-negative design for assessing vaccine efficacy.

  • 2

    Vaccine effectiveness (VE) measures how well vaccination protects against health outcomes in real-world conditions, differing from vaccine efficacy.

  • 3

    The test-negative design compares vaccination status between patients testing positive and negative for a disease to estimate VE.

  • 4

    This approach is preferred for studying vaccine effectiveness due to ethical concerns surrounding randomized controlled trials for existing vaccines.

  • 5

    The test-negative design is efficient and reduces bias by using health care facilities to identify cases and controls with similar symptoms.

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