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. 2021 Apr 15;384(15):1412-1423.
doi: 10.1056/NEJMoa2101765. Epub 2021 Feb 24.

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

Noa Dagan  1 , Noam Barda  1 , Eldad Kepten  1 , Oren Miron  1 , Shay Perchik  1 , Mark A Katz  1 , Miguel A Hernán  1 , Marc Lipsitch  1 , Ben Reis  1 , Ran D Balicer  1
Affiliations

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

Noa Dagan et al. N Engl J Med. .

Abstract

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.

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Figures

Figure 1
Figure 1. Study Population and Cohort Enrollment Process, December 20, 2020, to February 1, 2021.
The 1,503,216 persons vaccinated before February 1, 2021, were also required to be without a documented SARS-CoV-2 PCR-positive result before the vaccination date. Absolute numbers and percentage changes are shown for each inclusion and exclusion criterion. The exclusion process was gradual and occurred in phases; persons could have had more than one reason for exclusion. The same exclusion criteria were applied to the unvaccinated persons for each index date in which they were considered for matching. The chart focuses on the vaccinated population. CHS denotes Clalit Health Services.
Figure 2
Figure 2. Cumulative Incidence of the Five Outcomes.
Cumulative incidence curves (1 minus the Kaplan–Meier risk) for the various outcomes are shown, starting from the day of administration of the first dose of vaccine. Shaded areas represent 95% confidence intervals. The number at risk at each time point and the cumulative number of events are also shown for each outcome. Graphs in which all data are shown with a y axis scale from 0 to 100 (along with the data shown, as here, on an expanded y axis) are provided in Figure S8 in the Supplementary Appendix.
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