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Impact and effectiveness of mRNA BNT162b2 vaccine against SARS-CoV-2 infections and COVID-19 cases, hospitalisations, and deaths following a nationwide vaccination campaign in Israel: an observational study using national surveillance data
Open accessAbstract
Background Following the emergency use authorisation of the Pfizer-BioNTech mRNA COVID-19 vaccine BNT162b2 (international non-proprietary name tozinameran) in Israel, the Ministry of Health (MoH) launched a campaign to immunise the 6·5 million residents of Israel aged 16 years and older. We estimated the real-world effectiveness of two doses of BNT162b2 against a range of SARS-CoV-2 outcomes and to evaluate the nationwide public-health impact following the widespread introduction of the vaccine.Methods We used national surveillance data from the first 4 months of the nationwide vaccination campaign to ascertain incident cases of laboratory-confirmed SARS-CoV-2 infections and outcomes, as well as vaccine uptake in residents of Israel aged 16 years and older. Vaccine effectiveness against SARS-CoV-2 outcomes (asymptomatic infection, symptomatic infection, and COVID-19-related hospitalisation, severe or critical hospitalisation, and death) was calculated on the basis of incidence rates in fully vaccinated individuals (defined as those for whom 7 days had passed since receiving the second dose of vaccine) compared with rates in unvaccinated individuals (who had not received any doses of the vaccine), with use of a negative binomial regression model adjusted for age group (16-24, 25-34, 35-44, 45-54, 55-64, 65-74, 75-84, and ≥85 years), sex, and calendar week. The proportion of spike gene target failures on PCR test among a nationwide convenience-sample of SARS-CoV-2-positive specimens was used to estimate the prevelance of the B.1.1.7 variant.Findings During the analysis period (Jan 24 to April 3, 2021), there were 232 268 SARS-CoV-2 infections, 7694 COVID-19 hospitalisations, 4481 severe or critical COVID-19 hospitalisations, and 1113 COVID-19 deaths in people aged 16 years or older. By April 3, 2021, 4 714 932 (72·1%) of 6 538 911 people aged 16 years and older were fully vaccinated with two doses of BNT162b2. Adjusted estimates of vaccine effectiveness at 7 days or longer after the second dose were 95·3% (95% CI 94·9-95·7; incidence rate 91·5 per 100 000 person-days in unvaccinated vs 3·1 per 100 000 person-days in fully vaccinated individuals) against SARS-CoV-2 infection, 91·5% (90·7-92·2; 40·9 vs 1·8 per 100 000 person-days) against asymptomatic SARS-CoV-2 infection, 97·0% (96·7-97·2; 32·5 vs 0·8 per 100 000 person-days) against symptomatic COVID-19, 97·2% (96·8-97·5; 4·6 vs 0·3 per 100 000 person-days) against COVID-19-related hospitalisation, 97·5% (97·1-97·8; 2·7 vs 0·2 per 100 000 person-days) against severe or critical COVID-19-related hospitalisation, and 96·7% (96·0-97·3; 0·6 vs 0·1 per 100 000 person-days) against COVID-19-related death. In all age groups, as vaccine coverage increased, the incidence of SARS-CoV-2 outcomes declined. 8006 of 8472 samples tested showed a spike gene target failure, giving an estimated prevalence of the B.1.1.7 variant of 94·5% among SARS-CoV-2 infections.Interpretation Two doses of BNT162b2 are highly effective across all age groups (≥16 years, including older adults aged ≥85 years) in preventing symptomatic and asymptomatic SARS-CoV-2 infections and COVID-19-related hospitalisations, severe disease, and death, including those caused by the B.1.1.7 SARS-CoV-2 variant. There were marked and sustained declines in SARS-CoV-2 incidence corresponding to increasing vaccine coverage. These findings suggest that COVID-19 vaccination can help to control the pandemic.Funding None.
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“For context, for a state that is near the herd immunity threshold (70-80% based on recent estimates 22 ), a discrepancy of 10 percentage points in vaccination rates could be the difference between containment and uncontrolled exponential growth in new SARS-CoV-2 infections.”
From Unrepresentative big surveys significantly overestimated US vaccine uptake (2021) · cites this paper as [22]
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“Real-world setting studies performed, few months into vaccination campaigns, showed high effectiveness of these vaccines [1-8].”
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“As previously reported for other vaccines29–33, the neutralizing antibody titres against certain SARS-CoV-2 variants, such as the B.1.351 (Beta) and B.1.617.2 (Delta) variants, were lower than those against the parental strain WA1/2020.”
From Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine (2022) · cites this paper as [30]
Experimental — accuracy not yet measuredIn 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 [3]
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 [4]
In the citing paper
“At the time of this study, the B.1.1.7 variant was the most widespread variant in Israel and accounted for up to 94.5% of SARS-CoV-2 isolates.1,16”
From Covid-19 Breakthrough Infections in Vaccinated Health Care Workers (2021) · cites this paper as [1]
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 [1]
In the citing paper
“We identified the B.1.1.7 variant in 85% of cases, similar to its prevalence in the community.1,16”
From Covid-19 Breakthrough Infections in Vaccinated Health Care Workers (2021) · cites this paper as [1]
In the citing paper
“In cohort studies from Israel and Qatar, the BNT162b vaccine also retained greater than 90% efficacy against this variant 210,211 (TABLe 2).”
From The biological and clinical significance of emerging SARS-CoV-2 variants (2021) · cites this paper as [210]
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
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Negative binomial mixed models for analyzing microbiome count data
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Metadata
- Authors
- Haas, E. J., Angulo, F. J., McLaughlin, J. M., Anis, E., Singer, S. R., Khan, F., Brooks, N., Smaja, M., Mircus, G., Pan, K., Southern, J., Swerdlow, D. L., Jodar, L., Levy, Y., & Alroy-Preis, S.
- Affiliations
- Ben-Gurion University of the Negev (IL)
- Pfizer (United States) (US)
- Hebrew University of Jerusalem (IL)
- Israel Ministry of Health (IL)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2021-05
- Volume
- 397
- Issue
- 10287
- Pages
- 1819-1829
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC8099315
- OpenAlex
- W3158276912
- Semantic Scholar
- 096d4aae680648191460c8297e1a9d74c3a73c03
- Cited by
- 1,564
- References
- 19
- Citations by year
- 2026: 36 · 2025: 68 · 2024: 161 · 2023: 277 · 2022: 604 · 2021: 417
- FWCI
- 115.42
- Type
- journal article
- Language
- en
- Update notices
- erratum (2021-07-17)
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- Harvard University
- Weizmann Institute of Science
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- BNT162b2, COVID-19 mRNA vaccine, SARS-CoV-2, COVID-19 vaccine effectiveness, real-world effectiveness, COVID-19 hospitalization, COVID-19 mortality, asymptomatic infection, symptomatic infection, vaccine uptake, B.1.1.7 variant, public health impact
- MeSH terms
- COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, Adolescent, Adult, Aged, Aged, 80 and over, Female, Hospitalization, Humans, Israel, Male, Middle Aged, Population Surveillance, RNA, Messenger, Incidence, Mass Vaccination, Young Adult, Asymptomatic Infections, Pandemics
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