4.8 Article

BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting

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NEW ENGLAND JOURNAL OF MEDICINE
卷 384, 期 15, 页码 1412-1423

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MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2101765

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  1. Morris-Singer Fund

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A study conducted in Israel on nearly 600,000 individuals showed that the BNT162b2 mRNA vaccine was effective in reducing the risk of infection, hospitalization, and severe Covid-19. The effectiveness in preventing death was 72% during the period from day 14 through day 20 after the first dose, and hospitalization was reduced by 87% for the period 7 or more days after the second dose, similar to results from a randomized trial.
Background As mass vaccination campaigns against coronavirus disease 2019 (Covid-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel's largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine. Methods All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19-related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan-Meier estimator. Results Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% (95% confidence interval [CI], 40 to 51) and 92% (95% CI, 88 to 95); for symptomatic Covid-19, 57% (95% CI, 50 to 63) and 94% (95% CI, 87 to 98); for hospitalization, 74% (95% CI, 56 to 86) and 87% (95% CI, 55 to 100); and for severe disease, 62% (95% CI, 39 to 80) and 92% (95% CI, 75 to 100), respectively. Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups, with potentially slightly lower effectiveness in persons with multiple coexisting conditions. Conclusions This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19-related outcomes, a finding consistent with that of the randomized trial. Effectiveness of the BNT162b2 mRNA Vaccine in Israel Nearly 600,000 people in a large health care organization were followed after vaccination for infection, hospitalization, and severe Covid-19. Estimated vaccine effectiveness in preventing death was 72% during the period from day 14 through day 20 after the first dose, and for the period 7 or more days after the second dose, hospitalization was reduced by 87%. These results were similar to those reported in a randomized trial.

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