Cited by 2,527SARS-CoV-2 and COVID-19 ResearchVaccine Coverage and HesitancyCOVID-19 Clinical Research Studies

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

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Dagan, Noa, Barda, Noam, Kepten, Eldad, Miron, Oren, Perchik, Shay, Katz, Mark A., Hernán, Miguel A., Lipsitch, Marc +2 more·2021·New England Journal of Medicine

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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  • The 7-day cutoff for defining breakthrough infection was chosen based on previous research on BNT162b2 vaccine effectiveness.

    “The 7-day cutoff was chosen based on previous research the BNT162b2 vaccine effectivenesss1,11.”
  • Observational postmarketing studies, including this analysis, have consistently demonstrated a strong association between vaccination and risk reductions in COVID-19 hospitalization in immunocompetent individuals.

    “Observational postmarketing studies, including this analysis, have consistently demonstrated a strong association between vaccination and risk reductions in COVID-19 hospitalization in immunocompetent individuals, suggesting that the high efficacy observed in mRNA clinical trials translates into beneficial effects in the community setting.2,3,10”
  • High effectiveness (>80%) against severe disease and hospitalization has been reported for BNT162b2 and ChAdOx1 nCoV-19.

    “It should be noted that high effectiveness (>80%) against severe disease and hospitalization has been reported for both BNT162b2 (refs93,94) and ChAdOx1 nCoV-19 (ref.95).”
  • Early post-implementation analyses suggest mRNA vaccines reduce asymptomatic infection incidence and nasopharyngeal viral load in people infected despite vaccination.

    “Some early post-implementation analyses have suggested that the mRNA vaccines also reduce the incidence of asymptomatic infection and the nasopharyngeal viral load in individuals who become infected despite the vaccination93,107, but it is yet unclear how this translates to risk of transmission.”
  • The BNT162b2 Pfizer/BioNTech COVID-19 vaccine retains its efficacy against B.1.1.7 in the UK and in reports from Israel.

    “Current epidemiological evidence is that the BNT162b2 Pfizer/BioNTech COVID-19 vaccine retains its efficacy against B.1.1.7 in the UK24 and in reports from Israel.28,29”

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Authors
Dagan, N., Barda, N., Kepten, E., Miron, O., Perchik, S., Katz, M. A., Hernán, M. A., Lipsitch, M., Reis, B., & Balicer, R. D.
Affiliations
  • Ben-Gurion University of the Negev (IL)
  • From the Clalit Research Institute, Innovation Division, Clalit Health Services, Tel Aviv (N.D., N.B., E.K., O.M., S.P., M.A.K., R.D.B.), and the School of Public Health, Faculty of Health Sciences, Ben Gurion University of the Negev, Be’er Sheva (O.M., M.A.K., R.D.B.) — both in Israel; University of Michigan School of Public Health, Ann Arbor (M.A.K.); and the Department of Biomedical Informatics (N.D., N.B.), Harvard Medical School (B.R.), the Departments of Epidemiology and Biostatistics (M.A.H.), and the Center for Communicable Disease Dynamics, Departments of Epidemiology and of Immunology and Infectious Diseases (M.L.), Harvard T.H. Chan School of Public Health, Harvard–MIT Division of Health Sciences and Technology (M.A.H.), and the Predictive Medicine Group, Computational Health Informatics Program, Boston Children’s Hospital (B.R.) — all in Boston.
Corresponding author
Balicer, Ran D.
Venue
New England Journal of Medicine
Published
2021-04-15
Volume
384
Issue
15
Pages
1412-1423
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3131688063
Cited by
2,527
References
18
Citations by year
2026: 59 · 2025: 114 · 2024: 202 · 2023: 367 · 2022: 831 · 2021: 926 · 2020: 28
FWCI
184.41
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Morris–Singer Fund
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
Keywords
COVID-19 vaccine effectiveness, SARS-CoV-2 infection prevention, symptomatic COVID-19, COVID-19 hospitalization, severe COVID-19, COVID-19 mortality, mass vaccination campaigns, real-world effectiveness, comorbidities, Israel
MeSH terms
Immunogenicity, Vaccine, COVID-19, COVID-19 Vaccines, BNT162 Vaccine, Adolescent, Adult, Aged, Aged, 80 and over, Female, Hospitalization, Humans, Israel, Male, Middle Aged, Incidence, Treatment Outcome, Mass Vaccination, Kaplan-Meier Estimate, Young Adult

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