• Clin. Infect. Dis. · May 2021

    The effectiveness of the TWO-DOSE BNT162b2 vaccine: analysis of real-world data.

    • Gabriel Chodick, Lilac Tene, Ran S Rotem, Tal Patalon, Sivan Gazit, Amir Ben-Tov, Clara Weil, Inbal Goldshtein, Gilad Twig, Dani Cohen, and Khitam Muhsen.
    • Maccabi Institute for Research & Innovation, Maccabi Healthcare Services, Kaufman 4, Tel, Aviv Israel.
    • Clin. Infect. Dis. 2021 May 17.

    BackgroundCOVID-19 mRNA vaccines were shown to be highly efficacious in preventing the disease in randomized controlled trials; nonetheless, evidence on the real-world effectiveness of this vaccine is limited. Study objective was to evaluate the effectiveness of BNT162b2 vaccine in preventing SARS-CoV-2 infection and COVID-19-related hospitalization and mortality.MethodsThis historical cohort study included members of a large health provider in Israel that were vaccinated with at least one dose of BNT162b2. The primary outcome was incidence rate of a SARS-CoV-2 infection confirmed with rt-PCR, between 7 to 27 days after second dose (protection-period), as compared to days 1 to 7 after the first dose, where no protection by the vaccine is assumed (reference-period).ResultsData of 1,178,597 individuals vaccinated with BNT162b2 were analyzed (mean age 47.7 years [SD=18.1], 48.4% males) of whom 872,454 (74.0%) reached the protection period. Overall, 4514 infections occurred during the reference period compared to 728 during the protection period, yielding a weighted mean daily incidence of 54.8 per 100,000 (95%CI: 26.1-115.0 per 100,000) and 5.4 per 100,000 (95%CI: 3.5-8.4 per 100,000), respectively. The vaccine effectiveness in preventing infection was 90% (95%CI:79%- 95%) and 94% (95%CI:88%-97%) against COVID-19. Among immunosuppressed patients, vaccine effectiveness against infection was 71% (95%CI:37%-87%). The adjusted hazard ratios for hospitalization in those infected were 0.82 (95%CI:0.36-1.88), 0.45 (95%CI:0.23-0.90), and 0.56 (95%CI:0.36-0.89) in the age groups 16-44, 45-64 and 75 and above, respectively.ConclusionsThe effectiveness of the BNT162b2 vaccine is comparable to the one reported in the phase III clinical trial.© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

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