BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting
Authors: Miguel A Hernán
Ran D Balicer
Marc Lipsitch
Mark A Katz
Noa Dagan
Eldad Kepten
Shay Perchik
Ben Reis
Noam Barda
Oren Miron
Journal: New England Journal of Medicine (2021)
Discipline: CLINICAL MEDICINE
Keywords: mass vaccination campaigns; coronavirus disease 2019; Covid-19; BNT162b2 mRNA vaccine; vaccine effectiveness
Affiliations: From the Clalit Research Institute, Innovation Division, Clalit Health Services, Tel Aviv (N.D., N.B., E.K., O.M., S.P., M.A.K., R.D.B.), and the School of Public Health, Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er Sheva (O.M., M.A.K., R.D.B.) - both in Israel; University of Michigan School of Public Health, Ann Arbor (M.A.K.); and the Department of Biomedical Informatics (N.D., N.B.), Harvard Medical School (B.R.), the Departments of Epidemiology and Biostatistics (M.A.H.), and the Center for Communicable Disease Dynamics, Departments of Epidemiology and of Immunology and Infectious Diseases (M.L.), Harvard T.H. Chan School of Public Health, Harvard-MIT Division of Health Sciences and Technology (M.A.H.), and the Predictive Medicine Group, Computational Health Informatics Program, Boston Children's Hospital (B.R.) - all in Boston.

Abstract:  Background: As mass vaccination campaigns against coronavirus disease 2019 (Covid-19) commence worldwide, vaccine effectiveness needs to be assessed for a range of outcomes across diverse populations in a noncontrolled setting. In this study, data from Israel's largest health care organization were used to evaluate the effectiveness of the BNT162b2 mRNA vaccine. Methods: All persons who were newly vaccinated during the period from December 20, 2020, to February 1, 2021, were matched to unvaccinated controls in a 1:1 ratio according to demographic and clinical characteristics. Study outcomes included documented infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), symptomatic Covid-19, Covid-19-related hospitalization, severe illness, and death. We estimated vaccine effectiveness for each outcome as one minus the risk ratio, using the Kaplan-Meier estimator. Results: Each study group included 596,618 persons. Estimated vaccine effectiveness for the study outcomes at days 14 through 20 after the first dose and at 7 or more days after the second dose was as follows: for documented infection, 46% (95% confidence interval [CI], 40 to 51) and 92% (95% CI, 88 to 95); for symptomatic Covid-19, 57% (95% CI, 50 to 63) and 94% (95% CI, 87 to 98); for hospitalization, 74% (95% CI, 56 to 86) and 87% (95% CI, 55 to 100); and for severe disease, 62% (95% CI, 39 to 80) and 92% (95% CI, 75 to 100), respectively. Estimated effectiveness in preventing death from Covid-19 was 72% (95% CI, 19 to 100) for days 14 through 20 after the first dose. Estimated effectiveness in specific subpopulations assessed for documented infection and symptomatic Covid-19 was consistent across age groups, with potentially slightly lower effectiveness in persons with multiple coexisting conditions. Conclusions: This study in a nationwide mass vaccination setting suggests that the BNT162b2 mRNA vaccine is effective for a wide range of Covid-19-related outcomes, a finding consistent with that of the randomized trial. 

Retracted: No

PubPeer comments:
 I m a speaker of English, and a reader of Cell. If I read that the sense of touch has been restored to a paralyzed, unfeeling hand, I form the impression conveyed by the language. The individual can experience sensations of touch coming from his hand. Unless I m not reading this right, this is not the case here at all. There is a difference between saying (from the  In Brief blurb) that  Sensation is restored to the hand of a participant with quadriplegia by a brain-computer interface that transforms residual, sub-perceptual touch signals into conscious perception and saying (from the Summary) that  BCI almost fully restored the ability to detect object touch and significantly improved several sensorimotor functions. Afferent grip-intensity levels are also decoded fromM1, enabling grip reanimation regulated by touch signaling. The  ability to detect mentioned in the Summary and described in the text refers to sensations produced in a different part of the subject s body, not the hand (see Figure 1b), which the subject could then exploit to help manage the movement of the hand. This is simply not the same as  restoring touch to the hand. ,