2
views
0
recommends
+1 Recommend
1 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Exploring the reported adverse effects of COVID-19 vaccines among vaccinated Arab populations: a multi-national survey study

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          The coronavirus disease 2019 (COVID-19) pandemic has been a major challenge worldwide for the past years with high morbidity and mortality rates. While vaccination was the cornerstone to control the pandemic and disease spread, concerns regarding safety and adverse events (AEs) have been raised lately. A cross-sectional study was conducted between January 1st and January 22nd, 2022, in six Arabic countries namely Saudi Arabia, Egypt, Syria, Libya, Iraq, and Algeria. We utilized a self-administered questionnaire validated in Arabic which encompassed two main parts. The first was regarding sociodemographic data while the second was about COVID-19 vaccination history, types, doses, and experienced AEs. A multistage sampling was employed in each country, involving the random selection of three governorates from each country, followed by the selection of one urban area and one rural area from each governorate. We included the responses of 1564 participants. The most common AEs after the first and second doses were local AEs (67.9% and 46.6%, respectively) followed by bone pain and myalgia (37.6% and 31.8%, respectively). After the third dose, the most common AEs were local AEs (45.7%) and fever (32.4%). Johnson and Johnson, Sputnik Light, and Moderna vaccines showed the highest frequency of AEs. Factors associated with AEs after the first dose included an increase in age (aOR of 61–75 years compared to the 12–18 years group: 2.60, 95% CI: 1.59–4.25, p = 0.001) and male gender (OR: 0.72, 95% CI: 0.63–0.82, p < 0.001). The cumulative post-vaccination COVID-19 disease was reported with Sinovac (16.1%), Sinopharm (15.8%), and Johnson and Johnson (14.9) vaccines. History of pre-vaccination SARS-CoV-2 infection significantly increases the risk of post-vaccination COVID-19 after the first, second, and booster doses (OR: 3.09, CI: 1.9–5.07, p < 0.0001; OR: 2.56, CI: 1.89–3.47, p < 0.0001; and OR: 2.94, CI: 1.6–5.39, p = 0.0005 respectively). In conclusion, AEs were common among our participants, especially local AEs. Further extensive studies are needed to generate more generalizable data regarding the safety of different vaccines.

          Related collections

          Most cited references66

          • Record: found
          • Abstract: found
          • Article: found
          Is Open Access

          Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

          Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; p interaction =0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. Funding UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D’Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

            Background A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial. Methods We did a randomised, double-blind, placebo-controlled, phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia. We included participants aged at least 18 years, with negative SARS-CoV-2 PCR and IgG and IgM tests, no infectious diseases in the 14 days before enrolment, and no other vaccinations in the 30 days before enrolment. Participants were randomly assigned (3:1) to receive vaccine or placebo, with stratification by age group. Investigators, participants, and all study staff were masked to group assignment. The vaccine was administered (0·5 mL/dose) intramuscularly in a prime-boost regimen: a 21-day interval between the first dose (rAd26) and the second dose (rAd5), both vectors carrying the gene for the full-length SARS-CoV-2 glycoprotein S. The primary outcome was the proportion of participants with PCR-confirmed COVID-19 from day 21 after receiving the first dose. All analyses excluded participants with protocol violations: the primary outcome was assessed in participants who had received two doses of vaccine or placebo, serious adverse events were assessed in all participants who had received at least one dose at the time of database lock, and rare adverse events were assessed in all participants who had received two doses and for whom all available data were verified in the case report form at the time of database lock. The trial is registered at ClinicalTrials.gov (NCT04530396). Findings Between Sept 7 and Nov 24, 2020, 21 977 adults were randomly assigned to the vaccine group (n=16 501) or the placebo group (n=5476). 19 866 received two doses of vaccine or placebo and were included in the primary outcome analysis. From 21 days after the first dose of vaccine (the day of dose 2), 16 (0·1%) of 14 964 participants in the vaccine group and 62 (1·3%) of 4902 in the placebo group were confirmed to have COVID-19; vaccine efficacy was 91·6% (95% CI 85·6–95·2). Most reported adverse events were grade 1 (7485 [94·0%] of 7966 total events). 45 (0·3%) of 16 427 participants in the vaccine group and 23 (0·4%) of 5435 participants in the placebo group had serious adverse events; none were considered associated with vaccination, with confirmation from the independent data monitoring committee. Four deaths were reported during the study (three [<0·1%] of 16 427 participants in the vaccine group and one [<0·1%] of 5435 participants in the placebo group), none of which were considered related to the vaccine. Interpretation This interim analysis of the phase 3 trial of Gam-COVID-Vac showed 91·6% efficacy against COVID-19 and was well tolerated in a large cohort. Funding Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              The STROBE guidelines

              An observational study is a type of epidemiological study design, which can take the form of a cohort, a case–control, or a cross-sectional study. When presenting observational studies in manuscripts, an author needs to ascertain a clear presentation of the work and provide the reader with appropriate information to enable critical appraisal of the research. The Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines were created to aid the author in ensuring high-quality presentation of the conducted observational study. The original articles publishing the STROBE guidelines together with their bibliographies were identified and thoroughly reviewed. These guidelines consist of 22 checklist items that the author needs to fulfil before submitting the manuscript to a journal. The STROBE guidelines were created to aid the authors in presenting their work and not to act as a validation tool for the conducted study or as a framework to conduct an observational study on. The authors complying with these guidelines are more likely to succeed in publishing their observational study work in a journal.
                Bookmark

                Author and article information

                Contributors
                dr_samar11@yahoo.com
                Hossam.Tharwat@med.svu.edu.eg
                Journal
                Sci Rep
                Sci Rep
                Scientific Reports
                Nature Publishing Group UK (London )
                2045-2322
                27 February 2024
                27 February 2024
                2024
                : 14
                : 4785
                Affiliations
                [1 ]Department of Public Health and Community Medicine, Faculty of Medicine, Zagzig University, ( https://ror.org/053g6we49) Zagazig, Egypt
                [2 ]Membership at the Royal Colleague of General Practitioners [INT], London, UK
                [3 ]GRID grid.10772.33, ISNI 0000000121511713, Department of Mental Health Primary Care, , Nova University, ; Lisbon, Portugal
                [4 ]Research and Innovation Group, King Faisal Specialist Hospital and Research Center, ( https://ror.org/05n0wgt02) Riyadh, Saudi Arabia
                [5 ]GRID grid.415696.9, ISNI 0000 0004 0573 9824, Department of Family Medicine, Faculty of Medicine, , MOH, ; Riyadh, Saudi Arabia
                [6 ]Internship Year at Albayda Medical Center (AMC), Omar-Almukhtar University, ( https://ror.org/01wykm490) Albayad, Libya
                [7 ]GRID grid.440473.0, ISNI 0000 0004 0410 1298, Faculty of Medicine, , Badji Mokhtar, ; 23000 Annaba, Algeria
                [8 ]Department of Dermatology, Faculty of Medicine, University of Baghdad, ( https://ror.org/007f1da21) Baghdad, Iraq
                [9 ]Faculty of Medicine, University of Aleppo, ( https://ror.org/03mzvxz96) Aleppo, Syria
                [10 ]Department of Rheumatology and Rehabilitation, Faculty of Medicine, Zagzig University, ( https://ror.org/053g6we49) Zagazig, Egypt
                [11 ]Medical Microbiology and Immunology, Faculty of Medicine, Zagazig University, ( https://ror.org/053g6we49) Zagazig, Egypt
                [12 ]Endocrinology and Diabetes Division, Department of Internal Medicine, Faculty of Medicine, Zagazig University, ( https://ror.org/053g6we49) Zagazig, Egypt
                [13 ]Department of Biochemistry, Faculty of Pharmacy, Ain Shams University, ( https://ror.org/00cb9w016) Cairo, Egypt
                [14 ]Weill Cornell Medicine, ( https://ror.org/02r109517) New York, NY USA
                [15 ]Al Fatima Hospital, Karachi, Pakistan
                [16 ]GRID grid.415696.9, ISNI 0000 0004 0573 9824, Specialist Nursing, , Ministry of Health, ; Riyadh, Saudi Arabia
                [17 ]Qena Faculty of Medicine, South Valley University, ( https://ror.org/00jxshx33) Qena, 83621 Egypt
                [18 ]Lecturer of Public Health and Community Medicine, Faculty of Medicine, Zagazig University, ( https://ror.org/053g6we49) Zagazig, Egypt
                Author information
                http://orcid.org/0000-0002-9475-6372
                http://orcid.org/0000-0002-6476-1437
                http://orcid.org/0000-0002-6241-0895
                http://orcid.org/0000-0002-4050-193X
                http://orcid.org/0000-0001-5505-4397
                http://orcid.org/0000-0002-8135-7671
                http://orcid.org/0000-0003-4487-5223
                http://orcid.org/0000-0001-8077-5911
                Article
                54886
                10.1038/s41598-024-54886-0
                10899622
                38413637
                72736943-aad6-4704-9935-718725612a38
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 2 December 2023
                : 17 February 2024
                Categories
                Article
                Custom metadata
                © Springer Nature Limited 2024

                Uncategorized
                adverse effects,sars-cov-2,covid-19,coronavirus,vaccination,arab populations,vaccines,health care,medical research,signs and symptoms

                Comments

                Comment on this article