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 Eric J Haas, Frederick J Angulo, John M McLaughlin, Emilia Anis, Shepherd R Singer, Farid Khan, Nati Brooks, Meir Smaja, Gabriel Mircus, Kaijie Pan, Jo Southern, David L Swerdlow, Luis Jodar, Yeheskel Levy, Sharon Alroy-Preis Summary 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 232268 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, 4714932 (72∙1%) of 6538911 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 100000 person-days in unvaccinated vs 3·1 per 100000 person-days in fully vaccinated individuals) against SARS-CoV-2 infection, 91∙5% (90∙7–92∙2; 40∙9 vs 1∙8 per 100000 person-days) against asymptomatic SARS-CoV-2 infection, 97∙0% (96∙7–97∙2; 32∙5 vs 0∙8 per 100000 person-days) against symptomatic COVID-19, 97∙2% (96∙8–97∙5; 4∙6 vs 0∙3 per 100000 person-days) against COVID-19-related hospitalisation, 97∙5% (97∙1–97∙8; 2∙7 vs 0∙2 per 100000 person-days) against severe or critical COVID-19-related hospitalisation, and 96∙7% (96∙0–97∙3; 0·6 vs 0·1 per 100000 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. Copyright © 2021 Elsevier Ltd. All rights reserved. Lancet 2021; 397: 1819–29 Published Online May 5, 2021 https://doi.org/10.1016/ S0140-6736(21)00947-8 This online publication has been corrected. The corrected version first appeared at thelancet.com on July 15, 2021 See Comment page 1783 Public Health Services, Israel Ministry of Health, Jerusalem, Israel (E J Haas MD, E Anis MD, S R Singer MD, S Alroy-Preis MD); Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheva, Israel (E J Haas); Pfizer, Collegeville, PA, USA (F J Angulo PhD, J M McLaughlin PhD, F Khan MPH, K Pan MS, J Southern PhD, D L Swerdlow MD, L Jodar PhD); Hadassah Braun School of Public Health, Hebrew University, Jerusalem, Israel (E Anis, S R Singer); Information Technology Department, Israel Ministry of Health, Jerusalem, Israel (N Brooks MA, M Smaja BA); Pfizer Pharmaceuticals Israel, Herzliya, Israel (G Mircus PhD); Israel Ministry of Health, Jerusalem, Israel (Y Levy MD) Correspondence to: Dr Sharon Alroy-Preis, Public Health Services, Israel Ministry of Health, Jerusalem 9101002, Israel sharon.alroy@moh.gov.il Introduction As of April 3, 2021, the SARS-CoV-2 pandemic has resulted in more than 131 million cases and more than 2∙8 million deaths worldwide,1 including 821 748 cases and 6236 deaths in Israel2 (population 9·1 million). Among the SARS-CoV-2 strains characterised globally
