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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]
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“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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Molecular medical microbiology—from bench to bedside
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Chenchula, S., Chandra, M. B., Adusumilli, M. B., Ghanta, S. N., Bommasani, A., Anitha, K., Padmavathi, R., Amerneni, K. C., Chikatipalli, R., Ghanta, M. K., et al. (2024) · Reviews in Medical Virology · doi:10.1002/rmv.2515 · Cited by 17
“10 11–19 In addition to direct reductions in COVID ‐ 19 ‐ associated severity and mortality, vaccination has been associated with lower non ‐ COVID ‐ 19 mortality rates than non-vaccination after adjusting for confounding factors such as sex, age, race, ethnicity, and study site.”
BackgroundBayesian spatio-temporal analysis of the COVID-19 pandemic in Catalonia
Satorra, P., & Tebé, C. (2024) · Scientific Reports · doi:10.1038/s41598-024-53527-w · Cited by 16
Impact of vaccination status on clinical outcomes of hospitalized COVID-19 patients
Jelodar, M. G., Mirzaei, S., Saghafi, F., Rafieian, S., Rezaei, S., Saatchi, A., Avare, Z. D., & Niri, M. D. (2024) · BMC Infectious Diseases · doi:10.1186/s12879-024-09139-w · Cited by 17
“They also had fewer hospitalizations, less severe diseases, and lower mortality rates, a result consistent with the present study [22, 24, 25, 27, 28].”
ResultKemerley, A., Gupta, A., Thirunavukkarasu, M., Maloney, M., Burgwardt, S., & Maulik, N. (2024) · Current Issues in Molecular Biology · doi:10.3390/cimb46030124 · Cited by 16
Malli, F., Lampropoulos, I. C., Papagiannis, D., Papathanasiou, I. V., Daniil, Z. D., & Gourgoulianis, K. I. (2022) · Vaccines · doi:10.3390/vaccines10020337 · Cited by 16
“Haas, E.J.; Angulo, F.J.; McLaughlin, J.M.; Anis, E.; Singer, S.R.; Khan, F.; Brooks, N.; Smaja, M.; Mircus, G.; Pan, K.; et al. 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 obs…”
BackgroundInfluentialHatcher, S. M., Endres‐Dighe, S. M., Angulo, F. J., Srivastava, A. K., Nguyen, J. L., Khan, F. L., Martin, C., Swerdlow, D. L., McLaughlin, J. M., Ubaka-Blackmoore, N., et al. (2022) · Vaccines · doi:10.3390/vaccines10030393 · Cited by 17
“VE against severe disease or ICU admission ranged from 81% (95% CI: 79–83%) [15] to 100% [16,33]; the majority of results for VE against severe disease or ICU admission were 94% or greater [15,16,18,26,33,49,53].”
BackgroundInfluentialSelf-citationHealth system impacts of SARS-CoV − 2 variants of concern: a rapid review
Dol, J., Boulos, L., Somerville, M., Saxinger, L. M., Doroshenko, A., Hastings, S. E., Reynolds, B., Gallant, A. J., Shin, H. D., Wong, H. W. L., et al. (2022) · BMC Health Services Research · doi:10.1186/s12913-022-07847-0 · Cited by 16
“[59] conducted the first nationwide estimates on the vaccine effectiveness (VE) of two doses of the Pfizer vaccine on hospitalization and deaths in Israel during a period of high Alpha prevalence.”
BackgroundBermingham, C. R., Morgan, J., Ayoubkhani, D., Glickman, M., Islam, N., Sheikh, A., Sterne, J. A. C., Walker, A. S., & Nafilyan, V. (2022) · American Journal of Epidemiology · doi:10.1093/aje/kwac157 · Cited by 16
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Zhou, X., Lu, H., Sang, M., Qiu, S., Yuan, Y., Wu, T., Chen, J., & Sun, Z. (2023) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2023.2184754 · Cited by 16
Cuypers, L., Keyaerts, E., Hong, S. L., Gorissen, S., Menezes, S. M., Starick, M. R., Elslande, J. V., Weemaes, M., Wawina-Bokalanga, T., Martí‐Carreras, J., et al. (2023) · Nature Aging · doi:10.1038/s43587-023-00421-1 · Cited by 18
mRNA vaccines against COVID‐19: a showcase for the importance of microbial biotechnology
Brüssow, H. (2021) · Microbial Biotechnology · doi:10.1111/1751-7915.13974 · Cited by 16
Comprehensive antibody profiling of mRNA vaccination in childrenPreprint
Bartsch, Y. C., Denis, K. S., Kapłonek, P., Kang, J., Lam, E. C., Burns, M. D., Farkas, E. J., Davis, J. P., Boribong, B. P., Edlow, A. G., et al. (2021) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2021.10.07.463592 · Cited by 16
Alqahtani, Y. S. (2021) · Vaccines · doi:10.3390/vaccines10010041 · Cited by 15
“Noted also was a reduction in COVID-19-related hospitalizations, disease severity and death [34].”
BackgroundSasanami, M., Kayano, T., & Nishiura, H. (2022) · Mathematical Biosciences & Engineering · doi:10.3934/mbe.2022126 · Cited by 15
Rovida, F., Esposito, G. L., Rissone, M., Novelli, V., Cutti, S., Muzzi, A., Rona, C., Bertoli, E., Daglio, M., Piralla, A., et al. (2022) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2022.06.028 · Cited by 16
A Lesson from the Green Pass Experience in Italy: A Narrative Review
Campanozzi, L. L., Tambone, V., & Ciccozzi, M. (2022) · Vaccines · doi:10.3390/vaccines10091483 · Cited by 15
“aimed to reach the so-called herd immunity, while showing the high effectiveness of the new antidotes in stemming the incidence of SARS-CoV-2 infections [8,9].”
BackgroundBai, J., Chiba, A., Murayama, G., Kuga, T., Yahagi, Y., Tabe, Y., Tamura, N., & Miyake, S. (2022) · Scientific Reports · doi:10.1038/s41598-022-24938-4 · Cited by 17
The Efficacy of SARS-CoV-2 Vaccination in the Elderly: A Systemic Review and Meta-analysis
Yang, X. H., Bao, W. J., Zhang, H., Fu, S. K., & Jin, H. M. (2023) · Journal of General Internal Medicine · doi:10.1007/s11606-023-08254-9 · Cited by 16
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“It is noteworthy that during the early phase of vaccination scale-up, there were limited reported cases of breakthrough infections in high-income settings; 29,30 however, this changed with the arrival of the immunity-evasive Delta variant.”
Terzoli, S., Marzano, P., Cazzetta, V., Piazza, R., Sandrock, I., Ravens, S., Tan, L., Prinz, I., Balin, S., Calvi, M., et al. (2024) · npj Vaccines · doi:10.1038/s41541-024-00853-9 · Cited by 16
Williams, L. R., Ferguson, N. M., Donnelly, C. A., & Grassly, N. C. (2021) · Clinical Infectious Diseases · doi:10.1093/cid/ciab914 · Cited by 14
Figueroa-Pizano, M. D., Campa-Mada, A. C., Carvajal‐Millán, E., Martinez-Robinson, K. G., & Chu, A. R. (2021) · AIMS Public Health · doi:10.3934/publichealth.2021057 · Cited by 15
“how vaccination helps to control the pandemic [13].”
BackgroundFerreira, C. D. S., Dantés, H. G., Bellei, N., López, E. L., Crespo, K. A. N., O’Ryan, M., & Villegas, J. (2021) · Viruses · doi:10.3390/v13122391 · Cited by 16
COVID-19 vaccination status should not be used in triage tie-breaking
Schuman, O., Robertson‐Preidler, J., & Bibler, T. M. (2022) · Journal of Medical Ethics · doi:10.1136/medethics-2021-107836 · Cited by 15
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Brage, E. T., Roldán-Ruiz, J., Martín, J. G., Rodríguez, J. D. O., Tocino, R. V., Diego, S. R., Hernández, P. L. S., Hernández, L. B., & Sánchez, E. F. (2022) · Current Problems in Cancer Case Reports · doi:10.1016/j.cpccr.2022.100153 · Cited by 15
Breakthrough SARS-CoV-2 Infections after Vaccination in North Carolina
Uschner, D., Bott, M., Santacatterina, M., Gunaratne, M., Fette, L. M., Burke, B., Strylewicz, G., Edelstein, S. L., Lagarde, W. H., MILLER, K., et al. (2022) · Vaccines · doi:10.3390/vaccines10111922 · Cited by 17
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Clinical and genomic signatures of SARS-CoV-2 Delta breakthrough infections in New York
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“From the studies by Voysey et al. (AstraZeneca) [29], Jara et al. (Sinovac) [30], and Hass et al. (Pfizer) [31], it was found that the relative difference between the extremes of the 95% confidence interval in relation to the central estimate for the outcome variable of infection (2nd dose) was…”
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Risk management of the vaccine supply chain: Interactions of risk factors and control strategies
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COVID-19 Risk Assessment for the Tokyo Olympic Games
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Population differences in antibody response to SARS‐CoV‐2 infection and BNT162b2 vaccination
Shapira, G., Hamad, R. A., Weiner, C., Rainy, N., Sorek‐Abramovich, R., Benveniste‐Levkovitz, P., Rock, R., Avnat, E., Levtzion‐Korach, O., Chaim, A. B., et al. (2022) · The FASEB Journal · doi:10.1096/fj.202101492r · Cited by 12
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Self-citationDistinct Immune Response at 1 Year Post-COVID-19 According to Disease Severity
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Conformal Sensitivity Analysis for Individual Treatment Effects
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The effect of BNT 162b2 SARS‐C o V ‐2 m RNA vaccine on menstrual cycle symptoms in healthy women
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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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