Recommendations for estimating and reporting vaccine effectiveness by time since vaccination : a COVID-19 case study

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Kissling, Esther and Nunes, Baltazar and Hooiveld, Mariëtte and Martínez-Baz, Iván and Monge, Susana and Robertson, Chris and Knol, Mirjam and Sève, Noémie and Mlinarić, Ivan and Domegan, Lisa and Machado, Ausenda and Whitaker, Heather and Lazar, Mihaela and Meijer, Adam and Enkirch, Theresa and Casado, Itziar and Pérez-Gimeno, Gloria and William, Naoma and Enouf, Vincent and Filipović, Sanja Kurečić and McKenna, Adele and Rodrigues, Ana Paula and de Lusignan, Simon and Timnea, Olivia-Carmen and Latorre-Margalef, Neus and Castilla, Jesús and Pozo, Francisco and Hamilton, Mark and Masse, Shirley and Ilić, Maja and Basile, Luca and O’Donnell, Joan and Guiomar, Raquel and Riess, Maximilian and Popescu, Rodica-Manuela and Rose, Angela M C and Andrews, Nick and Bacci, Sabrina and Celentano, Lucia Pastore and Valenciano, Marta and Moren, Alain and Beutels, Philippe and Hens, Niel and ECDC primary care study teams, on behalf of I-MOVE-COVID-19 and (2025) Recommendations for estimating and reporting vaccine effectiveness by time since vaccination : a COVID-19 case study. American Journal of Epidemiology. ISSN 0002-9262 (https://doi.org/10.1093/aje/kwaf254)

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Abstract

Estimating COVID-19 vaccine effectiveness (VE) by time since vaccination (TSV) is essential for understanding how protection may change over time and enables meaningful comparisons across studies. This is important for accurate comparisons of VE against different SARS-CoV-2 variants/sublineages, across age groups, during different periods post vaccination campaign, or by vaccine type/brand. We provide recommendations for case–control VE studies on estimating and reporting VE analyses by TSV, with the aim of improving quality of these estimates. Our recommendations cover study design and pre-analysis considerations, descriptive analyses, choice of categories of TSV, categorical and continuous modelling approaches, and best practices for reporting VE by TSV. Using a real-life case–control study, we apply these recommendations, and include accompanying statistical scripts in R and Stata. These recommendations will serve as a practical resource for researchers conducting VE analyses by TSV. We encourage ongoing refinement of them through input from other study groups.

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