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

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. Supplementary Information The online version contains supplementary material available at 10.1007/s40261-022-01191-1.

Comparison of Adverse Effects of Two SARS-CoV-2 Vaccines Administered in Workers of the University of Padova

“…For the BNT162b2 vaccine, the number of systemic adverse events following immunization was lower after the first dose (13.5% of participants) and higher after the second dose (22% of participants). A similar trend was confirmed by another study of safety profiles conducted in Australia, Jordan, and the Netherlands [ 5 , 6 , 7 ].…”

Phase II/III Double-Blind Study Evaluating Safety and Immunogenicity of a Single Intramuscular Booster Dose of the Recombinant SARS-CoV-2 Vaccine “Patria” (AVX/COVID-12) Using an Active Newcastle Disease Viral Vector (NDV) during the Omicron Outbreak in Healthy Adults with Elevated Baseline Antibody Titers from Prior COVID-19 and/or SARS-CoV-2 Vaccination

“…Moreover, primary-series AZ/ChAdOx-1-S vaccination protects against COVID-19 hospitalization with enduring levels of vaccine effectiveness through ≥6 months, as indicated by consistent results in a meta-regression analysis. The analysis showed ≥80% protection against COVID-19 hospitalization through approximately 43 weeks post-second dose, with a certain decline (17,18). This vaccine was the most widely used in vaccination campaigns in Mexico and is the most utilized globally, distributed in 185 countries (2,17).…”

“…The analysis showed ≥80% protection against COVID-19 hospitalization through approximately 43 weeks post-second dose, with a certain decline (17,18). This vaccine was the most widely used in vaccination campaigns in Mexico and is the most utilized globally, distributed in 185 countries (2,17). Therefore, it serves as an excellent active control for the non-inferiority study of the AVX/COVID-12 vaccine.…”

“…Additionally, we conducted an active-controlled non-inferiority study (immunobridging) using the AZ/ChAdOx-1-S vaccine as the comparator, as both are vectorized vaccines. The AZ/ChAdOx-1-S vaccine has proven to be safe and effective against SARS-CoV-2 infection, demonstrating an effectiveness of 84.3% against asymptomatic SARS-CoV-2 infection and 98.9% against COVID-19 hospitalization (17,18). Moreover, it has become the most widely used vaccine globally, deployed in 185 countries since its approval for emergency use (19).…”

Real-World Effectiveness of Four Types of COVID-19 Vaccines

“…This study was part of a national research project in Jordan which evaluated the safety and effectiveness of COVID-19 vaccines among the general population. The first part of the project was an active safety surveillance of four types of COVID-19 vaccines [ 12 ]. The present study provided real-world evidence of the effectiveness of four vaccines (BNT162b2, BBIBP-CorV, ChAdOx1 nCoV-19, and Sputnik V) for the prevention of COVID-19 infection, hospitalization, and death.…”