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 a state near the herd immunity threshold (70-80%), 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.
“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]
The Discussion says transmission is likely to continue until population immunity exceeds a herd-immunity threshold, but gives an estimate of at least 60%, not 70–80%; it notes that variants could raise the threshold. The Results associate increasing vaccination coverage with declining infections. The paper does not assess whether a 10-percentage-point difference would separate containment from exponential growth in a state. (LLM, conf=0.85)
Experimental — accuracy not yet measuredReal-world studies performed a few months into COVID-19 vaccination campaigns showed high effectiveness of these vaccines.
“Real-world setting studies performed, few months into vaccination campaigns, showed high effectiveness of these vaccines [1-8].”
Neutralizing antibody titres against certain SARS-CoV-2 variants, such as B.1.351 (Beta) and B.1.617.2 (Delta), were lower than those against the parental strain WA1/2020.
“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]
The Discussion reports effectiveness against B.1.1.7 and says effectiveness against B.1.351 could not be estimated. Its mention of lower neutralising antibodies compares one vaccine dose with two, not variants with WA1/2020. Searches for Delta, WA1/2020, and variant-specific neutralising titres found no passage addressing the claimed comparison; page numbers were not available in our copy. (LLM, conf=0.76)
Experimental — accuracy not yet measuredObservational 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”
From Association Between mRNA Vaccination and COVID-19 Hospitalization and Disease Severity (2021) · cites this paper as [3]
The BNT162b2 vaccine has shown 94 to 95% efficacy and real-world effectiveness against symptomatic Covid-19 from 7 days after the second dose.
“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]
At the time of the study, B.1.1.7 was the most widespread variant in Israel and accounted for up to 94.5% of SARS-CoV-2 isolates.
“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]
The BNT162b2 vaccine has been highly effective in preventing clinically significant Covid-19.
“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]
The distribution of B.1.1.7 in breakthrough cases was similar to its prevalence in the community.
“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 cohort studies from Israel and Qatar, the BNT162b vaccine retained greater than 90% efficacy against the Alpha variant.
“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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The germinal centre B cell response to SARS-CoV-2
Laidlaw, B. J., & Ellebedy, A. H. (2021) · Nature reviews. Immunology · doi:10.1038/s41577-021-00657-1 · Cited by 250 · see citing works
Accelerated COVID-19 vaccine development: milestones, lessons, and prospects
Bok, K., Sitar, S., Graham, B. S., & Mascola, J. R. (2021) · Immunity · doi:10.1016/j.immuni.2021.07.017 · Cited by 254 · see citing works
“Studies to understand the impact of COVID-19 vaccination in immunocompromised patients are underway, and initial results suggest variable responses, depending on the specific population (Boyarsky et al., 2021; Haidar et al., 2021; Monin et al., 2021; Werbel et al., 2021).”
BackgroundGhattas, M., Dwivedi, G., Lavertu, M., & Alameh, M. (2021) · Vaccines · doi:10.3390/vaccines9121490 · Cited by 266 · see citing works
“Recent widespread emergence of highly infectious diseases such as Ebola, MERS, and SARS-CoV-2 has once again highlighted the importance of vaccination against deadly diseases.”
BackgroundInfluentialTaquet, M., Dercon, Q., & Harrison, P. J. (2022) · Brain, Behavior, and Immunity · doi:10.1016/j.bbi.2022.04.013 · Cited by 246 · see citing works
“Discussion 304 It is established that vaccination protects against hospitalisation, ICU admission, and death 305 from COVID-19 (Agrawal et al., 2021; Antonelli et al., 2021; Bahl et al., 2021; Butt et al., 306 2021; Cabezas et al., 2021; Glatman-Freedman et al., 2021; Haas et al., 2021; Hyams et al., 307 2021; Mateo-U…”
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Household Secondary Attack Rates of SARS-CoV-2 by Variant and Vaccination Status
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Impact of the delta variant on vaccine efficacy and response strategies
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BNT162b2 vaccination induces durable SARS-CoV-2–specific T cells with a stem cell memory phenotype
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Comparing the clinical efficacy of COVID-19 vaccines: a systematic review and network meta-analysis
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A comprehensive review of SARS-CoV-2 vaccines: Pfizer, Moderna & Johnson & Johnson
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“4% against severe or critical cases.(18) Table 1 presents efficacy values for symptomatic B.”
BackgroundMucosal Immune Response in BNT162b2 COVID-19 Vaccine Recipients
Azzi, L., Gasperina, D. D., Veronesi, G., Shallak, M., Ietto, G., Iovino, D., Baj, A., Gianfagna, F., Maurino, V., Focosi, D., et al. (2021) · EBioMedicine · doi:10.1016/j.ebiom.2021.103788 · Cited by 220 · see citing works
Protection against Covid-19 by BNT162b2 Booster across Age Groups
Bar-On, Y. M., Goldberg, Y., Mandel, M., Bodenheimer, O., Freedman, L. S., Alroy-Preis, S., Ash, N., Huppert, A., & Milo, R. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2115926 · Cited by 218 · see citing works
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“Estimates of effectiveness appear lower than in the general population [183,213,214], which is consistent with the findings of this review regarding a diminished immunogenicity and reports of more breakthrough infections observed in these populations [215e217].”
ResultRahmani, K., Shavaleh, R., Forouhi, M., Disfani, H. F., Kamandi, M., Oskooi, R. K., Foogerdi, M., Soltani, M., Rahchamani, M., Mohaddespour, M., et al. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.873596 · Cited by 207 · see citing works
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Public health impact of covid-19 vaccines in the US: observational study
Suthar, A. B., Wang, J., Seffren, V., Wiegand, R. E., Griffing, S., & Zell, E. (2022) · BMJ · doi:10.1136/bmj-2021-069317 · Cited by 189 · see citing works
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Gut microbiota composition is associated with SARS-CoV-2 vaccine immunogenicity and adverse events
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COVID-19 Vaccination Coverage Among Adults — United States, December 14, 2020–May 22, 2021
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Immunity to SARS‐CoV‐2 induced by infection or vaccination
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Waning effectiveness of the third dose of the BNT162b2 mRNA COVID-19 vaccine
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Emerging SARS-CoV-2 Variants: A Review of Its Mutations, Its Implications and Vaccine Efficacy
Ramesh, S., Govindarajulu, M., Parise, R. S., Neel, L. T., Shankar, T., Patel, S., Lowery, P., Smith, F., Dhanasekaran, M., & Moore, T. (2021) · Vaccines · doi:10.3390/vaccines9101195 · Cited by 152 · see citing works
Vaccination with BNT162b2 reduces transmission of SARS-CoV-2 to household contacts in Israel
Prunas, O., Warren, J. L., Crawford, F. W., Gazit, S., Patalon, T., Weinberger, D. M., & Pitzer, V. E. (2022) · Science · doi:10.1126/science.abl4292 · Cited by 153 · see citing works
Nordström, P., Ballin, M., & Nordström, A. (2021) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2021.100249 · Cited by 145 · see citing works
“Since the World Health Organization (WHO) issued its first emergency use validation for a vaccine against Coronavirus disease 2019 (Covid-19) [1], the efficacy of many different vaccines has been determined in clinical trials [2,3,4,5,6], with recent nationwide studies showing a high effectiveness of the ChAdOx1 nCoV-…”
BackgroundWaning Effectiveness of the Third Dose of the BNT162b2 mRNA COVID-19 Vaccine
Patalon, T., Saciuk, Y., Peretz, A., Perez, G., Lurie, Y., Maor, Y., & Gazit, S. (2022) · doi:10.1101/2022.02.25.22271494 · Cited by 143 · see citing works
Lustig, Y., Zuckerman, N. S., Nemet, I., Atari, N., Kliker, L., Regev‐Yochay, G., Sapir, E., Mor, O., Alroy‐Preis, S., Mendelson, E., et al. (2021) · Eurosurveillance · doi:10.2807/1560-7917.es.2021.26.26.2100557 · Cited by 143 · see citing works
Self-citationCytokine storm in COVID-19: from viral infection to immune responses, diagnosis and therapy
Jiang, Y.-Z., Rubin, L., Peng, T., Liu, L., Xing, X., Lazarovici, P., & Zheng, W. (2021) · International Journal of Biological Sciences · doi:10.7150/ijbs.59272 · Cited by 141 · see citing works
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“11,12 However, the occurrence of rare thrombotic events with thrombocytopenia after ChAdOx1 nCoV-19 vaccinations, especially in individuals younger than 60 years, associated with the generation of auto-platelet factor 4 antibodies, halted vaccination of this group with ChAdOx1 nCoV-19 in some…”
Grannis, S. J., Rowley, E. A. K., Ong, T. C., Stenehjem, E. A., Klein, N. P., DeSilva, M. B., Naleway, A. L., Natarajan, K., Thompson, M. G., & VISION Network (2021) · MMWR Morbidity and Mortality Weekly Report · doi:10.15585/mmwr.mm7037e2 · Cited by 136 · see citing works
Higdon, M. M., Wahl, B., Jones, C. B., Rosen, J. G., Truelove, S., Baidya, A., Nande, A., ShamaeiZadeh, P. A., Walter, K. K., Feikin, D. R., et al. (2022) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofac138 · Cited by 125 · see citing works
Barnes, E. J., Goodyear, C. S., Willicombe, M. K., Gaskell, C., Siebert, S., de Silva, T. I., Murray, S. M., Rea, D. W., Snowden, J. A., Carroll, M. W., et al. (2023) · Nature Medicine · doi:10.1038/s41591-023-02414-4 · Cited by 132 · see citing works
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Does infection with or vaccination against SARS-CoV-2 lead to lasting immunity?
Milne, G., Hames, T., Scotton, C. J., Gent, N., Johnsen, A., Anderson, R. M., & Ward, T. (2021) · The Lancet Respiratory Medicine · doi:10.1016/s2213-2600(21)00407-0 · Cited by 121 · see citing works
Optimization of non-coding regions for a non-modified mRNA COVID-19 vaccine
Gebre, M. S., Rauch, S., Roth, N., Yu, J., Chandrashekar, A., Mercado, N. B., He, X., Liu, J., McMahan, K., Martinot, A., et al. (2022) · Nature · doi:10.1038/s41586-021-04231-6 · Cited by 127 · see citing works
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“The recent evidence of reductions of SARS-CoV-2 infections, hospitalisations and deaths following nationwide COVID-19 vaccinations should also be informed to the public [33, 34].”
BackgroundHaas, E. J., McLaughlin, J. M., Khan, F. L., Angulo, F. J., Anis, E., Lipsitch, M., Singer, S. R., Mircus, G., Brooks, N., Smaja, M., et al. (2021) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(21)00566-1 · Cited by 125 · see citing works
Self-citationNationwide effectiveness of five SARS-CoV-2 vaccines in Hungary—the HUN-VE study
Vokó, Z., Kiss, Z., Surján, G., Surján, O., Barcza, Z., Pályi, B., Formanek-Balku, E., Molnár, G., Herczeg, R., Gyenesei, A., et al. (2021) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.11.011 · Cited by 113 · see citing works
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Fan, Y., Chan, K., & Hung, I. (2021) · Vaccines · doi:10.3390/vaccines9090989 · Cited by 108 · see citing works
“, 2021 [25] BNT162b2 Israel mRNA ≥16 years old Observational study 24 January–3 April, 2021 6,538,911 2 Intramuscular”
BackgroundTo mix or not to mix? A rapid systematic review of heterologous prime–boost covid-19 vaccination
Chiu, N., Chi, H., Tu, Y., Huang, Y.-N., Tai, Y., Weng, S.-L., Chang, L., Huang, D. T., Huang, F.-Y., & Lin, C. (2021) · Expert Review of Vaccines · doi:10.1080/14760584.2021.1971522 · Cited by 117 · see citing works
“Excellent vaccine effectiveness has been observed in real-world administrations, and increasing vaccine coverage is the next step in eliminating the pandemic [8].”
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Bivalent Omicron BA.1–Adapted BNT162b2 Booster in Adults Older than 55 Years
Winokur, P., Gayed, J., Fitz-Patrick, D., Thomas, S. J., Diya, O., Lockhart, S., Xu, X., Zhang, Y., Bangad, V., Schwartz, H. I., et al. (2023) · New England Journal of Medicine · doi:10.1056/nejmoa2213082 · Cited by 116 · see citing works
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The effect of COVID certificates on vaccine uptake, health outcomes, and the economy
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UVEITIS AFTER THE BNT162b2 mRNA VACCINATION AGAINST SARS-CoV-2 INFECTION: A Possible Association.
Rabinovitch, T., Ben‐Arie‐Weintrob, Y., Hareuveni‐Blum, T., Shaer, B., Vishnevskia‐Dai, V., Shulman, S., Newman, H., Biadsy, M., Masarwa, D., Fischer, N., et al. (2021) · PubMed · doi:10.1097/iae.0000000000003277 · Cited by 73 · see citing works
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COVID-19 vaccine breakthrough infections
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“This study extends our understanding of antibody response magnitude and durability following COVID-19 mRNA vaccination across the adult age spectrum [14, 18, 33-36].”
Callaghan, C. J., Mumford, L. L., Curtis, R. M. K., Williams, S. V., Whitaker, H., Andrews, N. J., Bernal, J. L., Ushiro‐Lumb, I., Pettigrew, G. J., Thorburn, D., et al. (2022) · Transplantation · doi:10.1097/tp.0000000000004059 · Cited by 104 · see citing works
The Global Impact of COVID-19 on Solid Organ Transplantation: Two Years Into a Pandemic
Nimmo, A., Gardiner, D. D., Ushiro‐Lumb, I., Ravanan, R., & Forsythe, J. L. R. (2022) · Transplantation · doi:10.1097/tp.0000000000004151 · Cited by 104 · see citing works
- 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 · 2020: 1
- 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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