Active Safety Surveillance of Four Types of COVID-19 Vaccines: A National Study from Jordan

Derar H. Abdel-Qader, Hasan Abdel-Qader, Jennifer Silverthorne, Chuenjid Kongkaew, Ahmad Z. Al Meslamani, Wail Hayajneh, Osama M.Abu Ata, Walid Shnaigat, Salah AbuRuz, Mohannad Al Nsour, Abdallah Alhariri, Khaldoun Shnewer, Mohammad Da’ssan, Nathir M. Obeidat, Khaldoon E. Nusair, Mothafer S. Jalamdeh, Feras Hawari, Khaldoun Khader, Tareq Hakim, Fatima A. HammadMustafa Al Qudah, Mohammad Asad

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)813-827
Number of pages15
JournalClinical Drug Investigation
Volume42
Issue number10
DOIs
Publication statusPublished - Oct 2022

ASJC Scopus subject areas

  • Pharmacology (medical)

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