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      Global prevalence and clinical manifestations of cutaneous adverse reactions following COVID‐19 vaccination: A systematic review and meta‐analysis

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          Abstract

          Although vaccination is widely accepted as an effective method of preventing and controlling the COVID‐19 pandemic, many people are concerned about possible cutaneous side‐effects, which can delay or prevent them from being vaccinated. The objectives of this systematic review were to assess the global prevalence and clinical manifestations of cutaneous adverse reactions following COVID‐19 vaccination. PubMed and Scopus databases were searched for articles published from 1 January 2019 to 31 December 2021, and reference lists for each selected article were screened. Case reports, case series, observational studies and randomized controlled trials that provided information on cutaneous adverse reactions following COVID‐19 vaccines were included. A total of 300 studies were included in a systematic review of which 32 studies with 946 366 participants were included in the meta‐analysis. The pooled prevalence of cutaneous manifestations following COVID‐19 vaccination was 3.8% (95% CI, 2.7%–5.3%). COVID‐19 vaccines based on the mRNA platform had a higher prevalence than other platforms at 6.9% (95% CI, 3.8%–12.3%). Various cutaneous manifestations have been reported from injection site reactions, which were the most common (72.16%) to uncommon adverse reactions such as delayed inflammatory reactions to tissue filler (0.07%) and flares of pre‐existing dermatoses (0.07%). Severe cutaneous reactions such as anaphylaxis have also been reported, but in rare cases (0.05%). In conclusion, cutaneous adverse reactions are common, especially in those receiving mRNA vaccines. Most reactions are mild and are not contraindications to subsequent vaccination except for anaphylaxis, which rarely occurs. COVID‐19 vaccination may also be associated with flares of pre‐existing dermatoses and delayed inflammatory reactions to tissue filler. Patients with a history of allergies, pre‐existing skin conditions or scheduled for filler injections should receive additional precounselling and monitoring. A better understanding of potential side‐effects may strengthen public confidence in those wary of new vaccine technologies.

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          Clinical Characteristics of Coronavirus Disease 2019 in China

          Wei-jie Guan, Zheng-yi Ni, Yu Hu … (2020)
          Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)
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            Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

            Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
            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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              Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

              Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)
              Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
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                Author and article information

                Contributors
                P. Rerknimitr:
                ORCID: https://orcid.org/0000-0003-2051-5573
                pawinee.r@chula.ac.th
                Journal
                Journal ID (nlm-ta): J Eur Acad Dermatol Venereol
                Journal ID (iso-abbrev): J Eur Acad Dermatol Venereol
                Journal ID (doi): 10.1111/(ISSN)1468-3083
                Journal ID (publisher-id): JDV
                Title: Journal of the European Academy of Dermatology and Venereology
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Print): 0926-9959
                ISSN (Electronic): 1468-3083
                Publication date (Electronic): 21 June 2022
                Publication date PMC-release: 21 June 2022
                Electronic Location Identifier: 10.1111/jdv.18294
                Affiliations
                [ 1 ] Division of Dermatology, Department of Medicine, Faculty of Medicine Chulalongkorn University Bangkok Thailand
                [ 2 ] Division of Nephrology, Department of Medicine, Faculty of Medicine Chulalongkorn University Bangkok Thailand
                [ 3 ] Division of Clinical Epidemiology, Department of Medicine, Faculty of Medicine Chulalongkorn University Bangkok Thailand
                [ 4 ] King Chulalongkorn Memorial Hospital Thai Red Cross Society Bangkok Thailand
                [ 5 ] Research Unit for Metabolic Bone Disease in CKD Patients, Faculty of Medicine Chulalongkorn University Bangkok Thailand
                [ 6 ] Department of Research Affairs Chulalongkorn University Bangkok Thailand
                [ 7 ] Skin and Allergy Research Unit Chulalongkorn University Bangkok Thailand
                Author notes
                [*] [* ]Correspondence: P. Rerknimitr. E-mail: pawinee.r@ 123456chula.ac.th
                [ † ]

                CW and JT equally contribute to this research paper.

                Author information
                https://orcid.org/0000-0003-2051-5573
                Article
                Publisher ID: JDV18294 Other ID: JEADV-2022-0950.R1
                DOI: 10.1111/jdv.18294
                PMC ID: 9348179
                PubMed ID: 35666609
                SO-VID: 17104a55-dd67-4db3-b6a9-1d6f434f2bb0
                Copyright © © 2022 European Academy of Dermatology and Venereology.
                License:

                This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.

                History
                Date received : 04 April 2022
                Date accepted : 18 May 2022
                Page count
                Figures: 3, Tables: 2, Pages: 22, Words: 19551
                Categories
                Subject: Systematic Review
                Subject: Systematic Reviews
                Custom metadata
                source-schema-version-number 2.0
                edited-state corrected-proof
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:03.08.2022

                ScienceOpen disciplines: Dermatology
                Keywords: cutaneous adverse reactions,covid‐19 vaccination,prevalence,clinical manifestation
                Data availability:
                ScienceOpen disciplines: Dermatology
                Keywords: cutaneous adverse reactions, covid‐19 vaccination, prevalence, clinical manifestation

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