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BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
Open accessAbstract
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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In the citing paper
“The 7-day cutoff was chosen based on previous research the BNT162b2 vaccine effectivenesss1,11.”
From Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine (2022) · cites this paper as [1]
In the citing paper
“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”
From Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity (2021) · cites this paper as [2]
In the citing paper
“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).”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [93]
In the citing paper
“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.”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [93]
In the citing paper
“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”
From Impact of SARS-CoV-2 variants on the total CD4+ and CD8+ T cell reactivity in infected or vaccinated individuals (2021) · cites this paper as [29]
In the citing paper
“A randomized, controlled trial and real-world studies have shown vaccine efficacy of 94 to 95% with the BNT162b2 vaccine (Pfizer–BioNTech) and vaccine effectiveness in preventing symptomatic coronavirus disease 2019 (Covid-19) 7 days or more after receipt of the second dose of vaccine.1,3-5”
From Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months (2021) · cites this paper as [3]
In the citing paper
“it is substantial and occurs during a time when neutralizing antibody titers are either very low or absent (Baden et al., 2020; Dagan et al., 2021; Polack et al., 2020).”
From SARS-CoV-2 mRNA vaccination induces functionally diverse antibodies to NTD, RBD, and S2 (2021) · cites this paper as Dagan et al., 2021
In the citing paper
“Since its rollout in late 2020 in Israel, the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) has been highly effective in preventing clinically significant coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1-3”
From Covid-19 Breakthrough Infections in Vaccinated Health Care Workers (2021) · cites this paper as [3]
In the citing paper
“Variability in estimates of vaccine effectiveness between studies could result from differences in study design, testing protocols, and study populations”
In the citing paper
“BNT162b2, a messenger RNA (mRNA)-based vaccine, has demonstrated a high efficacy rate with an acceptable safety profile. 1 2”
In the citing paper
“Likewise, clinical studies have reported somewhat reduced efficacy and effectiveness against the B.1.1.7, B.1.351, and B.1.617.2 variants (10–12).”
From Durability of mRNA-1273 vaccine–induced antibodies against SARS-CoV-2 variants (2021) · cites this paper as [11]
In the citing paper
“In a mass vaccination study which included 3,159,136 participants from Israel, vaccine effectiveness of BNT162b2 as a two-dose scheme was 94%.397”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [397]
In the citing paper
“>90% efficacy in real-world conditions in USA132 and Israel126”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [126]
In the citing paper
“In a mass vaccination campaign involving 3,159,136 participants in Israel, two doses of BNT162b2 were 94% effective at preventing symptomatic COVID-19, 87% effective at preventing hospitalizations and 92% effective at preventing the onset of severe COVID-19 (ref.126).”
From mRNA vaccines for infectious diseases: principles, delivery and clinical translation (2021) · cites this paper as [126]
In the citing paper
“Although BNT162b2 is a two-dose regimen, early protection after a single dose has been reported in clinical trials and on the basis of real-world data.5,19,20”
From Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents (2021) · cites this paper as [19]
In the citing paper
“Recent real-world data suggest that BNT162b2 prevents asymptomatic infection.19,27”
From Safety, immunogenicity, and efficacy of the BNT162b2 covid-19 vaccine in adolescents (2021) · cites this paper as [19]
In the citing paper
“Coronavirus disease 2019 (Covid-19) vaccines are highly effective against symptomatic disease and, more so, against severe disease and fatal outcomes caused by the original strain of SARS-CoV-2 as well as the alpha (B.1.1.7) variant that predominated in early 2021.”
From Effectiveness of COVID-19 vaccines against the Omicron (B.1.1.529) variant of concern (2021) · cites this paper as [14]
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Citations
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1 of the 18 references couldn’t be matched to a known paper.
Research works printed but not linked: 2
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Hayek, S., Ben‐Shlomo, Y., Dagan, N., Reis, B. Y., Barda, N., Kepten, E., Roitman, A., Shapira, S., Yaron, S., Balicer, R. D., et al. (2022) · Nature Communications · doi:10.1038/s41467-022-32253-9 · Cited by 14
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Metadata
- 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.
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-04-15
- Volume
- 384
- Issue
- 15
- Pages
- 1412-1423
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7944975
- OpenAlex
- W3131688063
- Cited by
- 2,527
- References
- 18
- Citations by year
- 2026: 59 · 2025: 114 · 2024: 202 · 2023: 367 · 2022: 831 · 2021: 926
- FWCI
- 184.41
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- 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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