Effectiveness of BNT162b2 Against Infection, Symptomatic Infection, and Hospitalization Among Older Adults Aged ≥65 Years During the Delta Variant Predominance in Japan: The VENUS Study.

Background: We evaluated the effectiveness of the BNT162b2 vaccine against infection, symptomatic infection, and hospitalization in older people during the Delta-predominant period (July 1 to September 30, 2021).

Methods: We performed a population-based cohort study in an older adult population aged ≥65 years using data from the Vaccine Effectiveness, Networking, and Universal Safety Study conducted from January 1, 2019, to September 30, 2021, in Japan. We matched BNT162b2-vaccinated and -unvaccinated individuals in a 1:1 ratio on the date of vaccination of the vaccinated individual. We evaluated the effectiveness of the vaccine against infection, symptomatic infection, and coronavirus disease (COVID-19)-related hospitalization by comparing the vaccinated and unvaccinated groups. We estimated the risk ratio and risk difference using the Kaplan-Meier method with inverse probability weighting. The vaccine effectiveness was calculated as (1 - risk ratio) × 100%.

Results: The study included 203,574 matched pairs aged ≥65 years. At 7 days after the second dose, the vaccine effectiveness of BNT162b2 against infection, symptomatic infection, and hospitalization was 78.1% (95% confidence interval [CI], 65.2-87.8%), 79.1% (95% CI, 64.6-88.9%), and 93.5% (95% CI, 83.7-100%), respectively.

Conclusion: BNT162b2 was highly effective against infection, symptomatic infection, and hospitalization in Japan's older adult population aged ≥65 years during the Delta-predominant period.