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Active Safety Surveillance of Four Types of COVID-19 Vaccines: A National Study from Jordan.
Abdel-Qader, Derar H; Abdel-Qader, Hasan; Silverthorne, Jennifer; Kongkaew, Chuenjid; Al Meslamani, Ahmad Z; Hayajneh, Wail; Ata, Osama M Abu; Shnaigat, Walid; AbuRuz, Salah; Al Nsour, Mohannad; Alhariri, Abdallah; Shnewer, Khaldoun; Da'ssan, Mohammad; Obeidat, Nathir M; Nusair, Khaldoon E; Jalamdeh, Mothafer S; Hawari, Feras; Khader, Khaldoun; Hakim, Tareq; Hammad, Fatima A; Al Qudah, Mustafa; Asad, Mohammad.
  • Abdel-Qader DH; Faculty of Pharmacy and Medical Sciences, University of Petra, Amman, Jordan. D.balawi@igec.com.au.
  • Abdel-Qader H; Al Rashid Hospital Center, Amman, Jordan. D.balawi@igec.com.au.
  • Silverthorne J; Ministry of Health, Amman, Jordan.
  • Kongkaew C; Division of Pharmacy and Optometry, The University of Manchester, Manchester, UK.
  • Al Meslamani AZ; Department of Pharmacy Practice, Naresuan University, Phitsanulok, Thailand.
  • Hayajneh W; AAU Health and Biomedical Research Center, Al Ain University, Abu Dhabi, United Arab Emirates.
  • Ata OMA; College of Pharmacy, Al Ain University, Abu Dhabi, United Arab Emirates.
  • Shnaigat W; School of Medicine, St. Louis University, St. Louis, MO, USA.
  • AbuRuz S; School of Medicine, Jordan University of Science and Technology, Irbid, Jordan.
  • Al Nsour M; King Hussein Cancer Center, Amman, Jordan.
  • Alhariri A; Al Rashid Hospital Center, Amman, Jordan.
  • Shnewer K; Department of Pharmacology and Therapeutics, College of Medicine and Health Sciences, The United Arab Emirates University, Al Ain, United Arab Emirates.
  • Da'ssan M; Department of Clinical Pharmacy, Faculty of Pharmacy, The University of Jordan, Amman, Jordan.
  • Obeidat NM; Eastern Mediterranean Public Health Network (EMPHNET), Amman, Jordan.
  • Nusair KE; Fourth Generation for Medical Laboratory, Amman, Jordan.
  • Jalamdeh MS; Fourth Generation for Medical Laboratory, Amman, Jordan.
  • Hawari F; Fourth Generation for Medical Laboratory, Amman, Jordan.
  • Khader K; School of Medicine, The University of Jordan, Amman, Jordan.
  • Hakim T; Fourth Generation for Medical Laboratory, Amman, Jordan.
  • Hammad FA; School of Medicine, The University of Jordan, Amman, Jordan.
  • Al Qudah M; King Abdullah University Hospital, Irbid, Jordan.
  • Asad M; Prince Hamza Hospital, Amman, Jordan.
Clin Drug Investig ; 42(10): 813-827, 2022 Oct.
Article in English | MEDLINE | ID: covidwho-2000149
ABSTRACT

BACKGROUND:

Although the Pfizer-BioNTech (BNT162b2), Oxford-AstraZeneca (ChAdOx1 nCoV-19), Sinopharm (BBIBP-CorV), and Sputnik V coronavirus disease 2019 (COVID-19) vaccines have been granted emergency approval in many nations, their safety has never been studied and compared in one community-based study. This study aimed to investigate and compare the incidence, nature, severity, and predictors of adverse events following immunization (AEFIs) with COVID-19 vaccines.

METHOD:

This was a prospective observational study conducted in Jordan between 1 January and 21 September 2021. A team of pharmacists and nurses (n = 407) collected the local and systemic AEFIs of four COVID-19 vaccines by prospectively contacting participants registered in the national vaccination program platform. A red-flag technology was inserted to classify and track rare and serious AEFIs.

RESULTS:

This study included 658,428 participants who were vaccinated with 1,032,430 doses; 610,591, 279,606, 140,843, and 1390 participants received the first and second doses of the BNT162b2, BBIBP-CorV, ChAdOx1 nCoV-19, and Sputnik V vaccines, respectively. The overall incidence of AEFIs was 28.8%, and the overall rates of systemic, local, and immediate hypersensitivity AEFIs were 22.2%, 18.8%, and 0.5%, respectively. The highest proportions of immediate hypersensitivity AEFIs and systemic AEFIs were reported after administration of the Sputnik V vaccine and ChAdOx1 nCoV-19 first dose, respectively. The most severe AEFIs were reported after ChAdOx1 nCoV-19 first dose and BNT162b2 second dose. The hospitalization and mortality rates after vaccination were 20 in 10,000 and 1 in 10,000, respectively. Based on red-flag tracking, the top three outcome events were lymphadenopathy (157.9/100,000), anxiety disorders (136.6/100,000), and lower respiratory tract infection (100.9/100,000), with Guillain-Barré syndrome (1.8/100,000), vasculitis (3.0/100,000), and myopericarditis (4.8/100,000) being the least common.

CONCLUSION:

The incidence rates of local, systemic, and immediate hypersensitivity AEFIs of four COVID-19 vaccines occur frequently. High incidence rates of rare and serious AEFIs were reported in this study. Younger participants, females, those who had previously had COVID-19, and smokers were more likely to encounter AEFIs.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 / Hypersensitivity, Immediate Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Female / Humans Country/Region as subject: Asia Language: English Journal: Clin Drug Investig Journal subject: Pharmacology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: S40261-022-01191-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 / Hypersensitivity, Immediate Type of study: Observational study / Prognostic study Topics: Vaccines Limits: Female / Humans Country/Region as subject: Asia Language: English Journal: Clin Drug Investig Journal subject: Pharmacology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: S40261-022-01191-1