Open AccessEvaluating real-world COVID-19 vaccine effectiveness using a test-negative case–control design
Author(s) -
Matthew W. Reynolds,
Alex Secora,
Alice Joules,
Lisa Albert,
Emma Brinkley,
Tom Kwon,
Christina Mack,
Stephen Toovey,
Nancy A Dreyer
Publication year - 2022
Publication title -
journal of comparative effectiveness research
Language(s) - Uncategorized
Resource type - Journals
SCImago Journal Rank - 0.567
H-Index - 23
eISSN - 2042-6313
pISSN - 2042-6305
DOI - 10.2217/cer-2022-0069
Subject(s) - covid-19 , medicine , test (biology) , pandemic , clinical trial , vaccination , virology , outbreak , disease , paleontology , infectious disease (medical specialty) , biology
Aim: It is important to assess if clinical trial efficacy translates into real-world effectiveness for COVID-19 vaccines. Materials & methods: We conducted a modified test-negative design (TND) to evaluate the real-world effectiveness of three COVID-19 vaccines. We defined cases in two ways: self-reported COVID-19-positive tests, and self-reported positive tests with ≥1 moderate/severe COVID-19 symptom. Results: Any vaccination was associated with a 95% reduction in subsequently reporting a positive COVID-19 test, and a 71% reduction in reporting a positive test and ≥1 moderate/severe symptom. Conclusion: We observed high effectiveness across all three marketed vaccines, both for self-reported positive COVID-19 tests and moderate/severe COVID-19 symptoms. This innovative TND approach can be implemented in future COVID-19 vaccine and treatment real-world effectiveness studies. Clinicaltrials.gov identifier: NCT04368065.