Association between vaccination status and COVID-19-related health outcomes among community-dwelling COVID-19 patients in Nara, Japan.

Background: Many previous studies have reported COVID-19 vaccine effectiveness, but there are few studies in Japan. This community-based, retrospective observational study investigated the association between vaccination status and COVID-19-related health outcomes in COVID-19 patients by SARS-CoV-2 variant type.

Methods: The study participants were 24,314 COVID-19 patients aged 12 or older whose diagnoses were reported to the Nara Prefecture Chuwa Public Health Center from April 2021 to March 2022, during periods when the alpha, delta, and omicron variants of COVID-19 were predominant. The outcome variables were severe health consequences (SHC) (i.e., ICU admission and COVID-19-related death), hospitalization, and extension of recovery period. The explanatory variable was vaccination status at least 14 days prior to infection. Covariates included gender, age, population size, the number of risk factors for aggravation, and the number of symptoms at diagnosis. The generalized estimating equations of the multivariable Poisson regression models were used to estimate the adjusted incidence proportion (AIP) and 95% confidence interval (CI) for each health outcome. We performed stratified analyses by SARS-CoV-2 variant type, but the association between vaccination status and COVID-19-related health outcomes was stratified only for the delta and omicron variants due to the small number of vaccinated patients during the alpha variant.

Results: Of the 24,314 participants, 255 (1.0%) had SHC; of the 24,059 participants without SHC, 2,102 (8.7%) were hospitalized; and of the 19,603 participants without SHC, hospitalization, and missing data on recovery period, 2,960 (15.1%) had extension of recovery period. Multivariable Poisson regression models showed that regardless of SARS-CoV-2 variant type or health outcome, those who received two or more vaccine doses had significantly lower risk of health outcomes than those who did not receive the vaccine, and there was a dose-response relationship in which the AIP for health outcomes decreased with an increased number of vaccinations.

Conclusion: A higher number of vaccinations were associated with lower risk of COVID-19-related health outcomes, not only in the delta variant but also in the omicron variant. Our findings suggest that increasing the number of COVID-19 vaccine doses can prevent severe disease and lead to early recovery of patients not requiring hospitalization.