tetano
Editor, Senior Moderator
Clin Drug Investig
. 2022 Aug 23.
doi: 10.1007/s40261-022-01191-1. Online ahead of print.
Active Safety Surveillance of Four Types of COVID-19 Vaccines: A National Study from Jordan
Derar H Abdel-Qader[SUP] 1 2 [/SUP], Hasan Abdel-Qader[SUP] 3 [/SUP], Jennifer Silverthorne[SUP] 4 [/SUP], Chuenjid Kongkaew[SUP] 5 [/SUP], Ahmad Z Al Meslamani[SUP] 6 7 [/SUP], Wail Hayajneh[SUP] 8 9 [/SUP], Osama M Abu Ata[SUP] 10 [/SUP], Walid Shnaigat[SUP] 11 [/SUP], Salah AbuRuz[SUP] 12 13 [/SUP], Mohannad Al Nsour[SUP] 14 [/SUP], Abdallah Alhariri[SUP] 15 [/SUP], Khaldoun Shnewer[SUP] 15 [/SUP], Mohammad Da'ssan[SUP] 15 16 [/SUP], Nathir M Obeidat[SUP] 15 16 [/SUP], Khaldoon E Nusair[SUP] 17 [/SUP], Mothafer S Jalamdeh[SUP] 18 [/SUP], Feras Hawari[SUP] 3 [/SUP], Khaldoun Khader[SUP] 3 [/SUP], Tareq Hakim[SUP] 3 [/SUP], Fatima A Hammad[SUP] 3 [/SUP], Mustafa Al Qudah[SUP] 3 [/SUP], Mohammad Asad[SUP] 14 [/SUP]
Affiliations
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.
. 2022 Aug 23.
doi: 10.1007/s40261-022-01191-1. Online ahead of print.
Active Safety Surveillance of Four Types of COVID-19 Vaccines: A National Study from Jordan
Derar H Abdel-Qader[SUP] 1 2 [/SUP], Hasan Abdel-Qader[SUP] 3 [/SUP], Jennifer Silverthorne[SUP] 4 [/SUP], Chuenjid Kongkaew[SUP] 5 [/SUP], Ahmad Z Al Meslamani[SUP] 6 7 [/SUP], Wail Hayajneh[SUP] 8 9 [/SUP], Osama M Abu Ata[SUP] 10 [/SUP], Walid Shnaigat[SUP] 11 [/SUP], Salah AbuRuz[SUP] 12 13 [/SUP], Mohannad Al Nsour[SUP] 14 [/SUP], Abdallah Alhariri[SUP] 15 [/SUP], Khaldoun Shnewer[SUP] 15 [/SUP], Mohammad Da'ssan[SUP] 15 16 [/SUP], Nathir M Obeidat[SUP] 15 16 [/SUP], Khaldoon E Nusair[SUP] 17 [/SUP], Mothafer S Jalamdeh[SUP] 18 [/SUP], Feras Hawari[SUP] 3 [/SUP], Khaldoun Khader[SUP] 3 [/SUP], Tareq Hakim[SUP] 3 [/SUP], Fatima A Hammad[SUP] 3 [/SUP], Mustafa Al Qudah[SUP] 3 [/SUP], Mohammad Asad[SUP] 14 [/SUP]
Affiliations
- PMID: 35999428
- DOI: 10.1007/s40261-022-01191-1
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.