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Vaccine · 2026

Comparing two case definitions for including severe acute respiratory infection patients in influenza and COVID-19 vaccine effectiveness studies among older adults using the test-negative design: VEBIS hospital network, seven European countries, 2023/24.

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Marques Diogo F P, Howard Jennifer, Álvarez Marcos Lozano, Machado Ausenda, Duffy Róisín, Túri Gergő, Kuliese Monika, Popovici Odette, Petrović Goranka, Lajot Adrien, Dürrwald Ralf, Cauchi John Paul, Trobajo-Sanmartín Camino, Husa Petr, Pozo Francisco, Verdasca Nuno, Wagner Eva Rivas, Gómez Verónica, Fitzgerald Margaret, Oroszi Beatrix, Jančorienė Ligita, Lazar Mihaela, Tabain Irena, Genderini Francesco G, Hackmann Carolin, Džiugytė Aušra, Echeverria Aitziber, Součková Lenka, Nicolay Nathalie, Bacci Sabrina, Nunes Baltazar, Rose Angela M C, VEBIS hospital network

Аннотация

INTRODUCTION: Two severe acute respiratory infection (SARI) case definitions (CDs) are often used in test-negative design (TND) hospital-based vaccine effectiveness (VE) studies. SARI-CD1 requires ≥1 symptom (cough, fever, shortness of breath, anosmia, ageusia, or dysgeusia); SARI-CD2 requires both fever and cough. Using VEBIS hospital network end-of-season 2023/24 data, we compared the effect of these CDs on influenza and COVID-19 VE estimates in Europe.

METHODS: Using the TND, we restricted analysis to seven countries recruiting patients using SARI-CD1; we created a subset of SARI patients also meeting SARI-CD2. Cases were RT-PCR-positive for influenza A(H1N1)pdm09, A(H3N2), or SARS-CoV-2; controls were influenza or SARS-CoV-2 RT-PCR-negative. We estimated VE among patients ≥65 years using logistic regression adjusted for country, onset date, age, sex, and chronic conditions. We estimated VE overall, by age group (65-79, ≥80 years) and time since vaccination (14-59, 60-119, ≥120 days). Absolute VE differences ≥10% were considered relevant.

RESULTS: Patient characteristics and outcomes were similar across CDs. SARI-CD1 had slightly more vaccinated cases, with little difference in controls between the two CDs. For influenza, the absolute VE difference between SARI-CD1 and SARI-CD2 was 10% for influenza A(H1N1)pdm09 (34% vs 44%), 19% among those aged ≥80 years (21% vs 40%) and 18% at 60-119 days post-vaccination (4% vs 22%). For SARS-CoV-2, absolute VE differences were 11% overall (29% vs 40%), 11% among ≥80 years (33% vs 44%), and 12% at 60-119 days (34% vs 46%). All other absolute VE differences were < 10%.

CONCLUSIONS: VE was similar for influenza A(H3N2), adults 65-79 years and 14-60 days post-vaccination. We observed signals of higher VE with SARI-CD2 for influenza A(H1N1)pdm09 and SARS-CoV-2, particularly among adults ≥80 years and ≥ 60 days post-vaccination, although 95% CIs overlapped. These signals suggest CDs may contribute to VE variability and VE studies should clearly indicate CDs used.

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

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