Bias assessment of a test-negative design study of COVID-19 vaccine effectiveness used in national policymaking

Sophie Graham (), Elise Tessier, Julia Stowe, Jamie Lopez Bernal, Edward P. K. Parker, Dorothea Nitsch, Elizabeth Miller, Nick Andrews, Jemma L. Walker and Helen I. McDonald
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Sophie Graham: London School of Hygiene and Tropical Medicine
Elise Tessier: UK Health Security Agency
Julia Stowe: UK Health Security Agency
Jamie Lopez Bernal: UK Health Security Agency
Edward P. K. Parker: London School of Hygiene and Tropical Medicine
Dorothea Nitsch: London School of Hygiene and Tropical Medicine
Elizabeth Miller: London School of Hygiene and Tropical Medicine
Nick Andrews: UK Health Security Agency
Jemma L. Walker: London School of Hygiene and Tropical Medicine
Helen I. McDonald: London School of Hygiene and Tropical Medicine

Nature Communications, 2023, vol. 14, issue 1, 1-10

Abstract: Abstract National test-negative-case-control (TNCC) studies are used to monitor COVID-19 vaccine effectiveness in the UK. A questionnaire was sent to participants from the first published TNCC COVID-19 vaccine effectiveness study conducted by the UK Health Security Agency, to assess for potential biases and changes in behaviour related to vaccination. The original study included symptomatic adults aged ≥70 years testing for COVID-19 between 08/12/2020 and 21/02/2021. A questionnaire was sent to cases and controls tested from 1–21 February 2021. In this study, 8648 individuals responded to the questionnaire (36.5% response). Using information from the questionnaire to produce a combined estimate that accounted for all potential biases decreased the original vaccine effectiveness estimate after two doses of BNT162b2 from 88% (95% CI: 79–94%) to 85% (95% CI: 68–94%). Self-reported behaviour demonstrated minimal evidence of riskier behaviour after vaccination. These findings offer reassurance to policy makers and clinicians making decisions based on COVID-19 vaccine effectiveness TNCC studies.

Date: 2023
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DOI: 10.1038/s41467-023-39674-0

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