Effectiveness of COVID-19 vaccine booster in the general population and in subjects with comorbidities. A population-based study in Spain

This work was supported by Framework Partnership Agreement between the Consellería de Sanidad de la XUNTA de Galicia and GENVIP-IDIS-2021–2024 (SERGAS-IDIS March 2021; Spain); and consorcio Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CB21/06/00103; F.M-T), DIAVIR (Instituto de Salud Carlos III (ISCIII)/DTS19/00049/Cofinanciado FEDER; Proyecto de Desarrollo Tecnológico en Salud), Resvi-Omics (Instituto de Salud Carlos III (ISCIII)/PI19/01039/Cofinanciado FEDER), BI-BACVIR (PRIS-3; Agencia de Conocimiento en Salud (ACIS)—Servicio Gallego de Salud (SERGAS)—Xunta de Galicia; Spain), Programa Traslacional COVID-19 (ACIS—Servicio Gallego de Salud (SERGAS)—XUNTA de Galicia; Spain) and Axencia Galega de Innovación (GAIN; IN607B 2020/08—XUNTA de Galicia; Spain) [A.S]; and ReSVinext (Instituto de Salud Carlos III (ISCIII)/PI16/01569/Cofinanciado FEDER), Enterogen (Instituto de Salud Carlos III (ISCIII)/PI19/01090/Cofinanciado FEDER), and Axencia Galega de Innovación (GAIN; IN845D 2020/23—Xunta de Galicia; Spain) [F.M-T]Background: Research on the effectiveness of COVID-19 booster-based vaccine schedule is ongoing and real-world data on vaccine effectiveness (VE) in comorbid patients are limited. We aimed to estimate booster dose VE against SARS-CoV-2 infection and COVID-19 severity in the general population and in comorbid patients. Method: A retrospective test-negative control study was undertaken in Galicia-Spain (December 2020–November 2021). VE and 95% confidence interval (CI) were estimated using multivariate logistic regression models. Results: 1,512,415 (94.13%) negative and 94,334 (5.87%) positive SARS-CoV-2 test results were included. A booster dose of COVID-19 vaccine is associated with substantially higher protection against SARS-CoV-2 infection than vaccination without a booster [VEboosted = 87% (95%CI: 83%; 89%); VEnon-boosted = 66% (95%CI: 65%; 67%)]. The high VE was observed in all ages, but was more pronounced in subjects older than 65 years. VE against COVID-19 severity was analyzed in a mixed population of boosted and non-boosted individuals and considerable protection was obtained [VE: hospitalization = 72% (95%CI: 68%; 75%); intensive care unit administration = 83% (95%CI: 78%; 88%), in-hospital mortality = 66% (95%CI: 53%; 75%)]. Boosted comorbid patients are more protected against SARS-CoV-2 infection than those who were non-boosted. This was observed in a wide range of major diseases including cancer (81% versus 54%), chronic obstructive pulmonary disease (84% versus 61%), diabetes (84% versus 65%), hypertension (82% versus 65%) and obesity (91% versus 67%), among others. Conclusions: A booster dose of COVID-19 vaccine increases the protection against SARS-CoV-2 infection and COVID-19 severity in the general population and in comorbid patients.S