TY - JOUR
T1 - Active Safety Surveillance of Four Types of COVID-19 Vaccines
T2 - A National Study from Jordan
AU - Abdel-Qader, Derar H.
AU - Abdel-Qader, Hasan
AU - Silverthorne, Jennifer
AU - Kongkaew, Chuenjid
AU - Al Meslamani, Ahmad Z.
AU - Hayajneh, Wail
AU - Ata, Osama M.Abu
AU - Shnaigat, Walid
AU - AbuRuz, Salah
AU - Al Nsour, Mohannad
AU - Alhariri, Abdallah
AU - Shnewer, Khaldoun
AU - Da’ssan, Mohammad
AU - Obeidat, Nathir M.
AU - Nusair, Khaldoon E.
AU - Jalamdeh, Mothafer S.
AU - Hawari, Feras
AU - Khader, Khaldoun
AU - Hakim, Tareq
AU - Hammad, Fatima A.
AU - Al Qudah, Mustafa
AU - Asad, Mohammad
N1 - Funding Information:
This study was funded by the Smart Labs Group and The Deanship of Scientific Research and Graduate Studies at the University of Petra.
Funding Information:
The authors thank all participants who volunteered to take part in this study, as well as all sub-investigators, study coordinators and site staff who contributed to the conduct of the study. The authors wish to acknowledge the Ministry of Health colleagues from the COVID-19 Vaccines Pharmacovigilance Committee, IT Department, and Project Management for their contributions to the overall project. The authors also wish to acknowledge EMPHNET for their technical assistance, digital solutions, and logistic and operational support related to this work.
Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Nature Switzerland AG.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
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U2 - 10.1007/s40261-022-01191-1
DO - 10.1007/s40261-022-01191-1
M3 - Article
C2 - 35999428
AN - SCOPUS:85136831715
SN - 1173-2563
VL - 42
SP - 813
EP - 827
JO - Clinical Drug Investigation
JF - Clinical Drug Investigation
IS - 10
ER -