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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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ResultInfluentialEffectiveness of COVID‑19 vaccines and their challenges (Review)
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“The COVID-19 vaccines have been validated in large-scale clinical trials and real-world settings to be protective and well-tolerable in general populations [4, 5].”
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“On 21 December 2020, Israel started a campaign to vaccinate the entire population above age 16 years, resulting in a dramatic drop in new infections [22].”
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ResultCardiovascular signatures of COVID-19 predict mortality and identify barrier stabilizing therapies
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“Of note, a large population-based survey including more than 4 million vaccines in Israel demonstrated an outstanding efficacy of above 95% for prevention of infection and, among those becoming infected, a protection from severe disease or hospitalization of more than 90% (Haas et al., 2021).”
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Meta-Analysis and Structural Dynamics of the Emergence of Genetic Variants of SARS-CoV-2
Castonguay, N., Zhang, W., & Langlois, M. (2021) · Frontiers in Microbiology · doi:10.3389/fmicb.2021.676314 · Cited by 28
COVID-19 vaccination in Israel
Muhsen, K., & Cohen, D. (2021) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2021.07.041 · Cited by 29
Botton, J., Dray‐Spira, R., Baricault, B., Drouin, J., Bertrand, M., Jabagi, M.-J., Weill, A., & Zureik, M. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.12.009 · Cited by 28
Nilsson, S. F., Laursen, T. M., Osler, M., Hjorthøj, C. R., Benros, M. E., Ethelberg, S., Mølbak, K., & Nordentoft, M. (2022) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2022.100355 · Cited by 28
Jin, Y., Fayyaz, A., Liaqat, A., Khan, A., Alshammari, A., Wang, Y., Gu, R., & Wei, D. (2023) · Computers in Biology and Medicine · doi:10.1016/j.compbiomed.2023.106893 · Cited by 31
Tamandjou Tchuem, C. R., Auvigne, V., Vaux, S., Montagnat, C., Paireau, J., Monnier Besnard, S., Gabet, A., Benhajkassen, N., Le Strat, Y., Parent Du Chatelet, I., et al. (2023) · Vaccine · doi:10.1016/j.vaccine.2023.02.062 · Cited by 27
Vaccinations, Mobility and COVID-19 Transmission
Guo, J., Deng, C. R., & Гу, Ф. (2021) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19010097 · Cited by 28
Magicova, M., Zahrádka, I., Fialova, M., Neskudla, T., Gurka, J., Módos, I., Hojny, M., Raška, P., Smejkal, P., Střı́ž, I., et al. (2022) · Transplantation · doi:10.1097/tp.0000000000004044 · Cited by 27
Verma, A. K., Kumar, I., Singh, P. K., Ansari, M. S., Singh, H. A., Sonkar, S., Prakash, A., Ojha, R., & Shukla, R. C. (2022) · European Radiology · doi:10.1007/s00330-021-08475-8 · Cited by 30
Hu, T., Li, L., Lin, C., Yang, Z., Chow, C., Lu, Z., & Chen, Y. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph19042300 · Cited by 28
“Despite the Omicron variant’s lightning speed of infection, the spread of the vaccine has reduced deaths from COVID-19 in many countries [5,6].”
BackgroundSaiag, E., Grupper, A., Avivi, I. M., Elkayam, O., Ram, R., Herishanu, Y., Cohen, Y. C., Perry, C., Furer, V., Katchman, H., et al. (2022) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2022.02.002 · Cited by 26
Socio-economic inequalities in physical activity among Japanese adults during the COVID-19 pandemic
Kyan, A., & Takakura, M. (2022) · Public Health · doi:10.1016/j.puhe.2022.03.006 · Cited by 28
Attitude and Acceptance of COVID-19 Vaccine in Parents and Adolescents: A Nationwide Survey
Lee, H., Choe, Y. J., Kim, S., Cho, H., Choi, E. H., Lee, J., Bae, H., Choi, S.-R., & You, M. (2022) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2022.05.018 · Cited by 28
Nilsson, S. F., Laursen, T. M., Osler, M., Hjorthøj, C. R., Benros, M. E., Ethelberg, S., Mølbak, K., & Nordentoft, M. (2021) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2022.100421 · Cited by 29
“3,4 However, factors such as limited access to vaccines, fear of being vaccinated, and possible waning immunity over time, make global immunisation a difficult target to reach.”
Rabiu, M., Peter, O. J., & Oguntolu, F. A. (2023) · Healthcare Analytics · doi:10.1016/j.health.2023.100240 · Cited by 34
Vaccination strategies between compulsion and incentives. The Italian Green Pass experience
Stefanizzi, P., Bianchi, F. P., Brescia, N., Ferorelli, D., & Tafuri, S. (2021) · Expert Review of Vaccines · doi:10.1080/14760584.2022.2023012 · Cited by 28
Shooting at a Moving Target—Effectiveness and Emerging Challenges for SARS-CoV-2 Vaccine Development
Günl, F., Mecate-Zambrano, A., Rehländer, S., Hinse, S., Ludwig, S., & Brunotte, L. (2021) · Vaccines · doi:10.3390/vaccines9101052 · Cited by 27
“5% reduction in asymptomatic infections [105].”
IHEANACHO, C. O., Eze, U. I. H., & Adida, E. A. (2021) · Bulletin of the National Research Centre/Bulletin of the National Research Center · doi:10.1186/s42269-021-00607-w · Cited by 27
Beran, J., Špajdel, M., & Slíva, J. (2021) · Viruses · doi:10.3390/v13112246 · Cited by 27
“their effect has been significant in terms of reducing the incidence of both symptomatic and asymptomatic cases [7].”
BackgroundSinger, S. R., Angulo, F. J., Swerdlow, D. L., McLaughlin, J. M., Hazan, I., Ginish, N., Anis, E., Mendelson, E., Mor, O., Zuckerman, N. S., et al. (2021) · EClinicalMedicine · doi:10.1016/j.eclinm.2021.101190 · Cited by 31
“A Ministry of Health (MoH) study during a period when 95% of specimens were variant Alpha reported VEs of >95% against infections, symptomatic infections, hospitalizations, deaths in Israel [8].”
InfluentialSelf-citationComparison of Neutralizing Antibody Responses at 6 Months Post Vaccination with BNT162b2 and AZD1222
Terpos, E., Karalis, V. D., Ntanasis‐Stathopoulos, I., Evangelakou, Z., Gavriatopoulou, M., Manola, M. S., Malandrakis, P., Gianniou, D. D., Kastritis, E., Trougakos, I. P., et al. (2022) · Biomedicines · doi:10.3390/biomedicines10020338 · Cited by 25
Yang, S. L., Ripen, A. M., Leong, C. T., Lee, J. V., Yen, C. H., Chand, A. K., Koh, K., Rahim, N. A. B. A., Gokilavanan, V., Mohamed, N. N. E., et al. (2022) · Emerging Microbes & Infections · doi:10.1080/22221751.2022.2065936 · Cited by 28
Research progress on vaccine efficacy against SARS-CoV-2 variants of concern
Bian, L., Liu, J., Gao, F., Gao, Q., He, Q., Mao, Q., Wu, X., Xu, M., & Liang, Z. (2022) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2022.2057161 · Cited by 30
“The estimated protective efficacies of the BNT162b2, mRNA-1273, and ChAdOx1 vaccines against infection with Delta are 56–88%, 72%, and 60–67%, respectively, which are slightly lower than the protective efficacies against Alpha (66– 95%, 83%, and 66–64%, respectively).(12,17,76) However, the prevention of severe illnes…”
BackgroundBerrou, I., Hamilton, K., Cook, C., Armour, C., Hughes, S., Hancock, J., Quigg, S., Hajinur, H., Srivastava, S., Kenward, C., et al. (2022) · Vaccines · doi:10.3390/vaccines10060840 · Cited by 27
Prins, M. L. M., Prins, C., de Vries, J. J. C., Visser, L. G., & Roukens, A. H. E. (2023) · Virus Research · doi:10.1016/j.virusres.2023.199175 · Cited by 27
“(Haas et al., 2021; Thompson et al., 2021) Especially early in the pandemic, vaccine stockpiles were insufficient to immunise the larger part of the world’s population.”
BackgroundTerpos, E., Karalis, V. D., Ntanasis‐Stathopoulos, I., Gavriatopoulou, M., Gumeni, S., Malandrakis, P., Papanagnou, E., Kastritis, E., Trougakos, I. P., & Dimopoulos, M. A. (2021) · Life · doi:10.3390/life11101077 · Cited by 27
Bosch, W., Cowart, J. B., Bhakta, S., Carter, R. E., Wadei, H. M., Shah, S. Z., Sanghavi, D., Pollock, B. D., Neville, M. R., Oman, S. P., et al. (2021) · Clinical Infectious Diseases · doi:10.1093/cid/ciab932 · Cited by 26
“The messenger RNA (mRNA) vaccines available in the United States, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna), have both shown ≥94% efficacy in preventing hospitalization in observational data [1, 2].”
Cambon, L., Schwarzinger, M., & Alla, F. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.11.023 · Cited by 29
Predictors of Severe Acute Respiratory Syndrome Coronavirus 2 Infection Following High-Risk Exposure
Andrejko, K. L., Pry, J. M., Myers, J. F., Openshaw, J. J., Watt, J., Birkett, N., DeGuzman, J. L., Barbaduomo, C. M., Dong, Z., Fang, A. T., et al. (2021) · Clinical Infectious Diseases · doi:10.1093/cid/ciab1040 · Cited by 27
Nucleic acid functionalized extracellular vesicles as promising therapeutic systems for nanomedicine
Liu, C., He, D., Cen, H., Chen, H., Li, L., Nie, G., Zhong, Z., He, Q., Yang, X., Guo, S., et al. (2022) · Extracellular Vesicles and Circulating Nucleic Acids · doi:10.20517/evcna.2021.21 · Cited by 26
Development of an LNP-Encapsulated mRNA-RBD Vaccine against SARS-CoV-2 and Its Variants
Liu, C., Rcheulishvili, N., Shen, Z., Papukashvili, D., Xie, F., Wang, Z., Wang, X., He, Y., & Wang, P. G. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14051101 · Cited by 27
Subedi, S., Filho, W. L., & Adedeji, A. (2023) · Journal of Public Health · doi:10.1007/s10389-023-02109-7 · Cited by 26
“Vaccine acceptance has been argued to substantially alter the pandemic course by decreasing morbidity and mortality (Haas et al. 2021; Meslé et al. 2021; Watson et al. 2022).”
Kertes, J., Gez, S. B., Saciuk, Y., Supino‐Rosin, L., Shamir-Stein, N., Mizrahi-Reuveni, M., & Zohar, A. E. (2021) · Emerging infectious diseases · doi:10.3201/eid2802.211834 · Cited by 32
“Initial population-based studies in Israel comparing vaccinated and unvaccinated groups reported vaccine effectiveness rates of 95% (5,6).”
BackgroundMhawish, H., Mady, A. M., Alaklobi, F., Aletreby, W., Asad, T., Al-Odat, M. A., Alharthy, A. M., Abdulrahman, B., Almahwi, S. A., & Memish, Z. A. (2021) · Annals of Medicine and Surgery · doi:10.1016/j.amsu.2021.102951 · Cited by 25
“…of the disease in terms of either symptomatic or asymptomatic presentation, or count of events of hospitalization, ICU admission, mechanical ventilation, or death [7,9,11,13,23,24], unani-mously concluding lower severity (according to the design of each study) in the group of immunized patients.”
Myocarditis after RNA-based vaccines for coronavirus.
Cordero, A., Morallón, D. C., Escribano, D., Quintanilla, M. A., López-Ayala, J. M., Pérez-Berbel, P., & Bertomeu‐González, V. (2022) · International Journal of Cardiology · doi:10.1016/j.ijcard.2022.01.037 · Cited by 25
Li, L., Müftüoğlu, M., Liang, S., Basyal, M., Lv, J., Akdogan, M. E., Chen, K., Andreeff, M., Flowers, C. R., & Parmar, S. (2022) · JCI Insight · doi:10.1172/jci.insight.156559 · Cited by 24
“individuals but highly effective at reducing the risk of severe infections and hospitalizations(34, 35).”
BackgroundWonder of wonders, miracle of miracles: the unprecedented speed of COVID-19 science
Saag, M. S. (2022) · Physiological Reviews · doi:10.1152/physrev.00010.2022 · Cited by 28
Pavan, M., Bassani, D., Sturlese, M., & Moro, S. (2022) · Journal of Enzyme Inhibition and Medicinal Chemistry · doi:10.1080/14756366.2022.2081847 · Cited by 24
Cheung, K. S., Lam, L.-K., Zhang, R., Ooi, P. H., Tan, J. T., To, E. W.-P., Hui, C.-H., Chan, K., Seto, W., Hung, I. F., et al. (2022) · Vaccines · doi:10.3390/vaccines10071122 · Cited by 25
“Among different measures to contain the spread of the virus, vaccination is of paramount importance in preventing infection, severe symptoms, and death [1].”
Backgroundvan den Hoogen, L. L., Boer, M. C., Postema, A., de Rond, L., de Zeeuw‐Brouwer, M., Pronk, I., Wijmenga‐Monsuur, A. J., Bijvank, E., Kruiper, C., Beckers, L., et al. (2022) · Vaccines · doi:10.3390/vaccines10091480 · Cited by 25
“This was subsequently confirmed by real-world data, when considering protection against severe COVID-19 [3,4].”
ResultAssociation Between Vaccination Status and Outcomes in Patients Admitted to the ICU With COVID-19*
van Diepen, S., McAlister, F. A., Chu, L. M., Youngson, E. R. E., Kaul, P., & Kadri, S. S. (2023) · Critical Care Medicine · doi:10.1097/ccm.0000000000005928 · Cited by 26
Calabrò, G. E., Pappalardo, C., D’Ambrosio, F., Vece, M., Lupi, C., Lontano, A., Russo, M. D., Ricciardi, R., & de Waure, C. (2023) · Vaccines · doi:10.3390/vaccines11051011 · Cited by 27
Cheng, C.-J., Lu, C., Chang, Y., Sun, Y., Chu, H., Lee, C., Liu, C.-H., Lin, C.-H., Lu, C.-J., & Li, C. (2021) · Vaccines · doi:10.3390/vaccines9121489 · Cited by 24
“Among the general population in the UK, the VE against asymptomatic infection after full vaccination either with BNT162b2 (VE: 58%) or ChAdOx1 (VE: 61%) was not as high as that in Israel (VE: 92%) (Figure 3A, Table 1A) [33,42].”
BackgroundResultInfluentialCohen, D., Izak, M., Stoyanov, E., Mandelboim, M., Perlman, S., Amir, Y., Goren, S., Bialik, A., Kliker, L., Atari, N., et al. (2023) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2023.04.395 · Cited by 25
“[5] Haas EJ, Angulo FJ, McLaughlin JM, Anis E, Singer SR, Khan F, et al.”
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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