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      Effectiveness of BNT162b2 vaccine against the B.1.1.7 variant of SARS-CoV-2 among healthcare workers in Brescia, Italy

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          Abstract

          OBJECTIVES

          : The aim of the study was to evaluate the effectiveness of BNT162b2 vaccine (Pfizer®) among healthcare workers (HCWs) while a recrudescence of pandemics was hitting the Brescia county, with a high rate of the B.1.1.7 variant.

          METHODS

          : The study was performed in the context of the mandatory health surveillance at the workplaces, in the period between 25th January 2021 and 26th March 2021, when 6904 HCWs (78% of workforce) gained full protection. HCWs were classified by having received the full vaccine schedule or not. The SARS-CoV-2 infection was diagnosed by conventional RT-PCR on rhino-pharyngeal swabs, followed by gene sequencing in positive vaccinated HCWs.

          RESULTS

          : We observed 84 SARS-CoV-2 infections among HCWs, most among unvaccinated HCWs. Gene sequencing was successful in 5 cases only, 4 B.1.1.7 and 1 B1.525 variants. In the same period, Lombardy registered 192.829 confirmed COVID-19 cases, 40.029 of which in Brescia county. The incidence rate of the B.1.1.7 variant rose from 70% to 97%.

          CONCLUSIONS

          : Results confirm the protective effects of BNT162b2. The vaccine campaign was effective not only in reducing the appearance of symptoms but also in decreasing the incidence of infections among vaccinated HCWs. We observed a reduced infection rate also among the residual unvaccinated HCWs.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Early evidence of the effect of SARS-CoV2 vaccine at One Medical Center

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              BNT162b2 mRNA Covid-19 vaccine effectiveness among health care workers.

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                Author and article information

                Journal
                J Infect
                J Infect
                The Journal of Infection
                The British Infection Association. Published by Elsevier Ltd.
                0163-4453
                1532-2742
                7 May 2021
                7 May 2021
                Affiliations
                [1 ]Unit of Occupational Health and Industrial Hygiene, DSMC, University of Brescia, Brescia, Italy
                [2 ]Unit of Occupational Health, Hygiene, Toxicology and Prevention, ASST Spedali Civili, 25123, Brescia, Italy
                [3 ]Chief Executive Office, ASST Spedali Civili di Brescia, Brescia, Italy
                [4 ]University Department of Infectious and Tropical Diseases, University of Brescia and ASST Spedali Civili, 25123 Brescia, Italy
                Author notes
                [* ]Corresponding author: Giuseppe De Palma, MD, PhD, Unit of Occupational Health and Industrial Hygiene, Dept. of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Piazzale Spedali Civili, 1 - 25123, Brescia, Italy. Telephone number: +39 0303995666.
                Article
                S0163-4453(21)00225-5
                10.1016/j.jinf.2021.04.038
                8102078
                33965428
                117eeae7-b787-4927-b254-8fa06a2aa82e
                © 2021 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 30 April 2021
                Categories
                Letter to the Editor

                Infectious disease & Microbiology
                coronavirus,covid-19,vaccine,herd immunity
                Infectious disease & Microbiology
                coronavirus, covid-19, vaccine, herd immunity

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